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October 25, 2026 3:33 am

BioNTech and Bristol Myers Squibb Report Encouraging Global Phase 2 Data for Pumitamig in Advanced NSCLC After Progression on Immunotherapy Plus Chemotherapy

Pumitamig plus docetaxel demonstrated encouraging responses in squamous and non-squamous non-small cell lung cancer across PD-L1 expression levels with a confirmed objective response rate of 36.7% following progression on or after immunotherapy plus chemotherapy
An early median progression-free survival of 6.9 months was observed
Significant unmet need remains for patients who have progressed on an
immunotherapy-containing regimen, with
the average progression-free survival below 4 months for standard of care
docetaxel
Data represent the third global Phase 2 dataset for pumitamig in lung cancer and reinforce its potential to improve outcomes over current standards of care

MAINZ, Germany, and PRINCETON, USA, October 25, 2026 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Bristol Myers Squibb Company (NYSE: BMY, “BMS”) today announced first data from the global Phase 2 ROSETTA Lung-107 clinical trial (NCT06841055) evaluating pumitamig, an investigational PD-L1xVEGF-A bispecific immunomodulator (BNT327/BMS986545), in combination with docetaxel in patients with metastatic non-small cell lung cancer (“NSCLC”) whose disease progressed on or after first-line immunotherapy plus chemotherapy.

The data showed encouraging antitumor activity, with responses observed in both squamous and non-squamous NSCLC and across PD-L1 expression levels, together with a manageable safety profile consistent with prior global datasets for pumitamig. The data were presented today in a late-breaking rapid oral presentation (abstract #LBA76) at the European Society for Medical Oncology (“ESMO”) Congress 2026 in Madrid, Spain.

“Despite meaningful advances in first-line treatment, outcomes remain poor for the many patients with non-small cell lung cancer whose disease progresses after immunotherapy plus chemotherapy, a setting where docetaxel has remained the standard of care for years,”¹ said Byoung Chul Cho, M.D., Ph.D., Trial Investigator and Professor of Medical Oncology at Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea. “These first data from ROSETTA Lung-107 show encouraging response rates and progression-free survival across PD-L1 expression levels and histology, suggesting that pumitamig may help re-engage antitumor immunity in patients who have progressed on prior immunotherapy plus chemotherapy. These findings support continued investigation of pumitamig in this population with high unmet need.”

ROSETTA Lung-107 is evaluating pumitamig 1400 mg in combination with docetaxel every three weeks. The July 10, 2026, data cut-off included 50 patients with a median follow-up of 12.2 weeks, and 33 patients remained on treatment. Among 30 efficacy-evaluable patients, pumitamig plus docetaxel showed a confirmed objective response rate (“cORR”) of 36.7% with a disease control rate (“DCR”) of 90.0%. Responses were observed across PD-L1 expression levels (cORR: 42.9% TPS ˂ 1%; 33.3% TPS 1–49%; 40.0% TPS ≥ 50%) and histologies (cORR: 57.1% squamous; 30.4% non-squamous), with DCRs above 80% in all subgroups. Median time to response was 1.4 months. In the overall treated population (n=50), median progression-free survival (“PFS”) was 6.9 months (95% CI: 4.2 – not reached), with a six-month PFS rate of 63.3%. Historically, standard-of-care docetaxel has delivered a median PFS of approximately 3.6 or 3.9 months for non-squamous and squamous metastatic NSCLC patients, respectively, following prior immunotherapy plus chemotherapy.¹

“Our ambition is to improve outcomes for patients across the full spectrum of lung cancer, spanning disease subtypes, stages and lines of therapy,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “These encouraging results for pumitamig plus docetaxel extend the clinical evidence to patients whose disease has progressed after immunotherapy plus chemotherapy, a setting in which treatment options remain limited. Together with our findings in first-line NSCLC and extensive-stage small cell lung cancer, they support our strategy to develop pumitamig across a broad range of lung cancer settings, including those with particularly high unmet medical need.”

“This is the third global Phase 2 dataset to show consistent activity for pumitamig in lung cancer across PD-L1 expression levels, and it extends our evidence into a second-line setting where current options fall short,” said Cristian Massacesi, Executive Vice President, Chief Medical Officer and Head of Development at Bristol Myers Squibb. “Together with BioNTech, we are advancing one of the broadest development programs in the class as we continue to build the growing body of clinical evidence for pumitamig across multiple types and treatment lines of lung cancer, with four ongoing global Phase 3 trials, and we look forward to defining the path forward for pumitamig in second-line NSCLC.”

Across 50 patients in the safety evaluation, pumitamig plus chemotherapy showed a manageable safety profile, with no new safety signals. Pumitamig treatment-related adverse events (“TRAEs”) of any grade were reported in 52.0% of patients and grade ≥ 3 TRAEs in 18.0%, leading to treatment discontinuation in four (8.0%) patients. Immune- related AEs occurred in 11 (22.0%) patients and grade ≥ 3 immune- related AEs in five (10.0%) patients. VEGF-related events were reported in 13 (26.0%) patients; grade 3 events were rare (two patients, 4.0%), with no grade 4 or 5 events. Bleeding events occurred in eight (16.0%) patients and were limited to grade 1 or 2 severity. There were no pumitamig-related deaths or dose-limiting toxicities (“DLTs”).

BioNTech and BMS are advancing a broad development plan for pumitamig in multiple cancer types, including lung cancer across disease stages, subgroups and lines of therapy. ROSETTA Lung-107 extends the program into the second-line NSCLC setting, and these data will inform the further development of pumitamig in this underserved patient population.

About ROSETTA Lung-107

The global, open-label, single-arm Phase 2 ROSETTA Lung-107 trial (NCT06841055) is evaluating pumitamig (BNT327/BMS986545) in combination with docetaxel in patients with stage IV squamous or non-squamous NSCLC whose disease progressed following first-line immunotherapy plus chemotherapy, with any level of PD-L1 expression. Patients with prior exposure to anti-VEGF monoclonal antibodies or PD-(L)1xVEGF bispecific antibodies were excluded. In Part 1 (safety run-in), patients received pumitamig 1400 mg or 2000 mg plus docetaxel 75 mg/m² every three weeks (Q3W). In Part 2 (dose expansion), patients received pumitamig 1400 mg plus docetaxel 75 mg/m² Q3W, the dose recommended by the internal review committee based on the totality of evidence from Part 1 and the broader pumitamig lung cancer program. The primary endpoints are dose-limiting toxicities (Part 1 only), safety, and objective response rate (“ORR”) per investigator’s assessment (RECIST 1.1). Secondary endpoints include disease control rate (“DCR”), duration of response (“DOR”), depth of response, time to response, progression-free survival (“PFS”), overall survival (“OS”), pharmacokinetics, and antidrug antibody prevalence. The trial enrolled 59 patients at sites in Australia, the Republic of Korea, Spain, Türkiye, the United Kingdom, and the United States.

About Pumitamig

Pumitamig is an investigational bispecific immunomodulator, jointly developed by BioNTech and BMS, designed to cooperatively bind to PD-L1 and VEGF-A. It is aimed at restoring the immune system’s ability to recognize and destroy tumor cells while simultaneously cutting off the blood and oxygen supply that feeds tumor cells (anti-angiogenesis effect), preventing them from growing and proliferating. By anchoring to PD-L1 receptors on tumor cells, we believe pumitamig localizes VEGF-A blockade within the tumor microenvironment, potentially enhancing antitumor activity while minimizing systemic exposure.

More than 4,000 patients have been treated with pumitamig in clinical trials to date. Seven global Phase 3 trials with registrational potential are currently ongoing, evaluating pumitamig plus chemotherapy compared to standard of care treatments, in first-line small cell lung cancer (ROSETTA Lung-01, NCT06712355); first-line non-small cell lung cancer (ROSETTA Lung-02, NCT06712316); unresectable stage III non-small cell lung cancer (ROSETTA Lung-201, NCT07361497); first-line advanced PD-L1 ≥ 50% non-small cell lung cancer (ROSETTA Lung-202, NCT07361510); first-line triple-negative breast cancer (ROSETTA Breast-01, NCT07173751); first-line microsatellite stable colorectal cancer (ROSETTA CRC-203, NCT07221357); and first-line gastric cancer (ROSETTA Gastric-204, NCT07221149). Pumitamig is also being explored in 10+ novel-novel combination trials with ADCs and other novel modalities, with the aim of expanding its role across tumor types and identifying additional pivotal opportunities.

About NSCLC

Non-small cell lung cancer (NSCLC) covers all epithelial lung cancers other than small cell lung cancer and includes squamous cell carcinoma, large cell carcinoma, and adenocarcinoma of the lung. It is the most common type of lung cancer, accounting for approximately 85% of cases, and is the leading cause of cancer-related deaths worldwide.² Scientific advances have transformed the treatment of NSCLC, improving outcomes for many patients. However, NSCLC remains an aggressive disease with a poor prognosis and a 5-year survival rate of 18 to 22% in advanced stages.³ Patients with low levels of PD-L1 expression typically do not respond well to checkpoint inhibitor-based regimens creating a significant unmet need for new treatment options that provide durable responses to a broad range of patients.

About BioNTech

BioNTech is a global next generation biopharmaceutical company pioneering novel investigative therapies for cancer and other serious diseases. In oncology, BioNTech is committed to transforming how cancer is treated. Its ambition is to develop innovative medicines with pan-tumor or synergistic potential to address cancer from multiple angles and across the full continuum of the disease from early- to late-stage. Its growing late-stage oncology pipeline comprises complementary treatment approaches spanning immunomodulators, antibody-drug conjugates, and mRNA cancer immunotherapies. BioNTech has partnered with multiple global and specialized pharmaceutical collaborators leveraging complementary expertise and resources to accelerate innovation and drive progress, including Bristol Myers Squibb, Duality Biologics, Genentech, a member of the Roche Group, Genmab, MediLink, OncoC4, and Pfizer.

For more information, please visit www.BioNTech.com.

BioNTech Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: BioNTech’s collaboration with Bristol Myers Squibb (BMS); BioNTech and BMS’s ability to successfully co-develop and co-commercialize pumitamig (also known as BNT327 or BMS986545), if approved; the rate and degree of market acceptance of pumitamig, if approved; the initiation, timing, progress, and results of BioNTech’s research and development programs, including BioNTech’s current and future clinical trials, including statements regarding the expected timing of initiation, enrollment, and completion of trials and related preparatory work and the availability of results, and the timing and outcome of applications for regulatory approvals and marketing authorizations, including expectations regarding the potential indications in which pumitamig may be approved, if at all; the targeted timing and number of additional potentially registrational trials, and the registrational potential of any trial BioNTech may initiate; and discussions with regulatory agencies. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.

The forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events and are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control and which could cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with clinical data, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the nature of clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the impact of tariffs and escalations in trade policy; competition related to BioNTech’s product candidates; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for its product candidates; BioNTech’s ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech’s third-party collaborators to continue research and development activities relating to BioNTech’s product candidates and investigational medicines; unforeseen safety issues and potential claims that are alleged to arise from the use of products and product candidates developed or manufactured by BioNTech; BioNTech’s and its collaborators’ ability to commercialize and market its product candidates, if approved; BioNTech’s ability to manage its development and related expenses; regulatory and political developments in the United States and other countries; BioNTech’s ability to effectively scale its production capabilities and manufacture its products and product candidates; and other factors not known to BioNTech at this time.

You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech’s Report on Form 6-K for the period ended June 30, 2026 and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at www.sec.gov. These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise.

About Bristol Myers Squibb

At Bristol Myers Squibb, our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We are pursuing bold science to define what’s possible for the future of medicine and the patients we serve. For more information, visit us at BMS.com and follow us on LinkedIn, X, YouTube, Facebook and Instagram.

Bristol Myers Squibb Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about Bristol Myers Squibb’s future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that the expected benefits of, and opportunities related to the collaboration with BioNTech may not be realized by Bristol Myers Squibb or may take longer to realize than anticipated, that future study results may not be consistent with the results to date, that pumitamig (also known as BNT327 or BMS986545) alone or in combination with chemotherapy (such as docetaxel) may not achieve its primary study endpoint or receive regulatory approval for the indications described in this release in the currently anticipated timeline or at all, any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether pumitamig alone or in combination with chemotherapy will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2025, as updated by Bristol Myers Squibb’s subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

CONTACTS

BioNTech

Media Relations

Jasmina Alatovic
[email protected]

Investor Relations

Douglas Maffei, PhD
[email protected]

Bristol Myers Squibb

Media Relations

[email protected]

Investor Relations

[email protected]

1. Ahn MJ et al. J Clin Oncol. 2025;43(3):260–272.
2. Lin Z et al. Medicine (Baltimore). 2025 Jul 25;104(30):e43300.
3. Liu SV et al. Immunotherapy. 2025 Oct;17(14):1005-1013.

October 24, 2026 7:33 pm

Climb Bio Presents Initial PrisMN Phase 2 Data from Budoprutug in pMN at an Oral Session at ASN Kidney Week 2026

Low dose (200 mg) budoprutug demonstrated B-cell depletion, PLA2R Ab reduction, and immunologic remission at 12 weeks, consistent with Phase 1b data; additional data from the PrisMN Phase 2 study anticipated in 2027

200 mg and 600 mg doses have been generally well-tolerated

Separate MCD case study described three-year steroid-free remission following budoprutug treatment, supporting further investigation

WELLESLEY HILLS, Mass., Oct. 24, 2026 (GLOBE NEWSWIRE) — Climb Bio, Inc. (Nasdaq: CLYM), a clinical stage biotechnology company developing therapeutics for patients with immune-mediated diseases, today announced new clinical data for budoprutug, its anti-CD19 monoclonal antibody (mAb), in two immune-mediated renal diseases, primary membranous nephropathy (pMN) and minimal change disease (MCD). These data were presented at the American Society of Nephrology (ASN) Kidney Week 2026, which is taking place October 21-25, 2026, in Denver, Colorado.

PrisMN is an ongoing Phase 2 dose-escalation trial evaluating budoprutug at three dose levels (200 mg, 600 mg, and 1000 mg) in patients with moderate to severe pMN. Patients enrolled in the reported cohorts were treatment-experienced, with high proteinuria and elevated PLA2R antibody levels at baseline. At Week 12, the 200 mg cohort demonstrated B-cell depletion, reductions in PLA2R antibody levels, and immunologic remission. Initial data from the ongoing 600 mg cohort suggest greater drug exposure and deeper peripheral B-cell depletion compared with 200 mg. Budoprutug has been generally well tolerated in both cohorts to date, with follow-up through Week 12 for 200 mg and Week 6 for 600 mg. Enrollment is ongoing in the 1000 mg cohort.

In a separate case study presented yesterday, one patient with frequently relapsing MCD received 100 mg of budoprutug. The patient experienced three-year steroid-free remission and remained in remission for one year following B-cell reconstitution. This observation supports further investigation of budoprutug in MCD.

“Current treatment strategies fail to induce complete remission in most patients with pMN, underscoring the need for more effective treatments,” said Dr. Frank Cortazar, Director of the New York Nephrology Vasculitis and Glomerular Center. “While complete remission often takes more than a year to achieve, changes in PLA2R antibody levels can be appreciated much earlier in the treatment course and serve as an early indicator of therapeutic efficacy. Reductions in PLA2R antibody levels have been shown to correlate with downstream improvements in proteinuria, and ultimately complete remission. In the PrisMN study, the low-dose budoprutug cohort demonstrated encouraging PLA2R antibody reductions and immunologic remission rates in patients with moderate to severe pMN. These early results are highly promising, and I look forward to seeing how these data evolve as follow-up continues and higher-dose cohorts read out. These data provide further evidence that targeting CD19 with budoprutug may be a compelling approach in the treatment of pMN.”

“These initial PrisMN results build on our Phase 1b findings, demonstrating early immunologic activity at 200 mg and the potential for increased activity at higher doses,” said Aoife Brennan, M.B., Ch.B., President and Chief Executive Officer of Climb Bio. “The observed pharmacokinetics confirm that patients with pMN have increased clearance of budoprutug compared to patients who do not have proteinuria. We are encouraged by the greater exposure and deeper B-cell depletion we are seeing at these early time points in the 600 mg cohort. As enrollment and follow-up continue, we look forward to sharing additional data. Beyond pMN, we are encouraged by the sustained steroid-free remission reported in the MCD case, supporting further investigation of budoprutug in additional glomerular diseases and highlighting its potential impact across different B-cell mediated diseases.”

Key highlights from the oral presentation:

Early immunologic activity at 200 mg
- Mean PLA2R antibody reduction of 70% at Week 12; five of 13 patients (38%) achieved immunologic remission. Mean reduction of 80% at Week 12 for patients with baseline PLA2R antibody (Ab) <175 RU/mL
- Phase 2 Week 12 data consistent with Phase 1b Week 12 data across B-cell depletion, anti-PLA2R antibody reduction, and immunologic remission rate
Population PK analysis and emerging 600 mg data support the evaluation of higher doses
- Population PK analysis completed across all budoprutug studies (n≈120) found that patients with high proteinuria (median UPCR of 6.8 g/g) clear budoprutug ≥2-fold faster than non-proteinuric individuals, supporting the use of higher doses in pMN
- Mean peripheral CD20+ B-cell suppression at Week 4 was 98% at 600 mg, compared with 74% at 200 mg
Safety and tolerability
- Budoprutug was generally well tolerated in the 200 mg and 600 mg cohorts
- Most adverse events were mild to moderate (Grade 1 or 2), with no treatment-related serious adverse events, adverse events leading to treatment discontinuation, or deaths reported

Following the oral presentation at 5:30 p.m. MT., the presentation and poster will be available on the Pipeline & Science—Publications page of the Company’s website here.

About Primary Membranous Nephropathy (pMN)

Primary membranous nephropathy is an autoantibody mediated disease characterized by proteinuria, nephrotic syndrome, and progressive loss of renal function. Patients with uncontrolled disease may develop chronic kidney disease or end-stage kidney disease, requiring dialysis or transplantation. There are about 75,000 people in the U.S. living with pMN. Currently, there are no FDA approved therapies for pMN.

About Climb Bio, Inc.

Climb Bio, Inc. is a clinical-stage biotechnology company with a mission to deliver high impact, disease-modifying medicines for individuals living with immune-mediated diseases, including those affecting kidney health. The Company’s pipeline includes, budoprutug, an anti-CD19 monoclonal antibody that has potential to treat a broad range of B-cell mediated diseases, and CLYM116, an anti-APRIL monoclonal antibody being developed for IgA nephropathy. For more information, please visit climbbio.com.

About Budoprutug

Budoprutug is a clinical-stage, anti-CD19 monoclonal antibody with the potential to address a broad range of B-cell mediated, immune-driven diseases. Designed with enhanced effector function and low picomolar affinity, budoprutug targets and depletes CD19-expressing B cells, including plasmablasts and certain plasma cells, key sources of pathogenic autoantibodies. Early clinical data suggest budoprutug may offer durable B-cell depletion, rapid reductions in autoantibodies, and clinical remission in primary membranous nephropathy (pMN). Budoprutug is being evaluated in clinical trials for pMN, immune thrombocytopenia (ITP), and systemic lupus erythematosus (SLE). A subcutaneous formulation is also in development to enable broader patient access. Budoprutug has been granted Orphan Drug Designation and Fast Track Designation by the FDA for the treatment of pMN.

Forward-Looking Statements

This press release contains “forward-looking statements” including, without limitation, statements regarding: future expectations, plans and prospects for Climb Bio; expectations regarding the therapeutic benefits, clinical potential and clinical development of budoprutug; the anticipated timelines for announcing data from Climb Bio’s ongoing and planned clinical trials; the anticipated timelines for enrolling patients in planned clinical trials; and other statements containing the words “anticipate,” “continue,” “could,” “expect,” “intend,” “may,” “plan,” “potential,” “should,” “suggest,” “target,” “will” and similar expressions. Forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. Climb Bio may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. These risks and uncertainties include, but are not limited to, important risks and uncertainties associated with: the ability of Climb Bio to timely and successfully achieve or recognize the anticipated benefits of its technology transfer and exclusive license agreement with Mabworks; Climb Bio’s ability to advance budoprutug and CLYM116 on the timelines expected or at all and to obtain and maintain necessary approvals from the U.S. Food and Drug Administration and other regulatory authorities; obtaining and maintaining the necessary approvals from investigational review boards at clinical trial sites and independent data safety monitoring boards; replicating in clinical trials positive results found in early-stage clinical trials or nonclinical studies; competing successfully with other companies that are seeking to develop treatments for primary membranous nephropathy, immune thrombocytopenia, systemic lupus erythematosus, IgA nephropathy and other immune-mediated diseases; maintaining or protecting intellectual property rights related to budoprutug, CLYM116 and/or its other product candidates; managing expenses; changes in applicable laws or regulations; the possibility that Climb Bio may be adversely affected by other economic, business and/or competitive factors; and raising the substantial additional capital needed, on the timeline necessary, to continue development of budoprutug, CLYM116 and any other product candidates Climb Bio may develop. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Climb Bio’s actual results to differ materially from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in Climb Bio’s most recent filings with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Climb Bio’s views as of the date hereof and should not be relied upon as representing Climb Bio’s views as of any date subsequent to the date hereof. Climb Bio anticipates that subsequent events and developments will cause Climb Bio’s views to change. However, while Climb Bio may elect to update these forward-looking statements at some point in the future, Climb Bio specifically disclaims any obligation to do so, except as required by law.

Investors and Media

Carlo Tanzi, Ph.D.
Kendall Investor Relations
[email protected]

October 24, 2026 2:34 pm

CCC Investors Have Opportunity to Join CCC Intelligent Solutions Holdings Inc. Fraud Investigation with SBS Law

CCC Investors Have Opportunity to Join CCC Intelligent Solutions Holdings Inc. Fraud Investigation with SBS Law

LOS ANGELES–(BUSINESS WIRE)–Schall, Brown & Schwartz LLP (“SBS”), a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors in CCC Intelligent Solutions Holdings Inc. (“CCC” or “the Company”) (NASDAQ: CCC) for potential breaches of fiduciary duty on the part of its directors and management.

INVESTIGATION DETAILS: The investigation focuses on determining if the CCC board breached its fiduciary duties to shareholders. The Company agreed to be taken private by a group including GTRC LLC and Elliott Investment Management L.P., with shareholders receiving $7.75 per share. CCC Chairman Githesh Ramamurthy and CCC President Tim Welsh will roll over their equity into the private company.

If you are a shareholder who suffered a loss, click here to participate.

We also encourage you to contact Brian Schall or David Schwartz of Schall, Brown & Schwartz LLP, 2049 Century Park East, Suite 2460, Los Angeles, CA 90067, at 310-301-3335, to discuss your rights free of charge. You can also reach us through the firm’s website at www.schallfirm.com, or by email at [email protected]

WHY SBS? Schall, Brown & Schwartz LLP represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation. Bringing together the extensive experience and diverse skillsets of founding partners Brian Schall, Andrew Brown, and David Schwartz, SBS is dedicated to aggressively advocating for every investor.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics.

View source version on businesswire.com: https://www.businesswire.com/news/home/20261024303997/en/

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October 24, 2026 11:21 am

Pfizer’s 25-Valent Pediatric Pneumococcal Conjugate Vaccine Candidate Shows Robust Phase 2 Data at IDWeek 2026

Pfizer’s 25-Valent Pediatric Pneumococcal Conjugate Vaccine Candidate Shows Robust Phase 2 Data at IDWeek 2026

Investigational vaccine shows strong immune responses in infants equivalent to PREVNAR 20^®on shared serotypes and for five new serotypes, potentially offering the broadest protection against invasive pneumococcal disease (IPD) for pediatric population in the U.S.

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) today announced detailed results across serotypes from a Phase 2 study (NCT06524414) for its investigational 25-valent pneumococcal conjugate vaccine candidate, PF-07872412 (25vPnC), in infants. In the study, a four-dose series of 25vPnC elicited robust immune responses against all 25 serotypes and showed safety and tolerability comparable to four doses of PREVNAR 20^® (Pneumococcal 20-valent Conjugate Vaccine). These findings were shared today in an oral presentation at IDWeek 2026 in Washington, D.C.¹

These data support the ongoing Phase 3 development program for 25vPnC, which, if successful, could help provide protection against serotypes collectively responsible for approximately 84% of invasive pneumococcal disease (IPD) cases among children under five years of age in the U.S.²

“These encouraging data build on more than 25 years of progress in protecting children from serious pneumococcal disease with PREVNAR vaccines. By expanding serotype coverage and applying next-generation technology to the historically challenging serotype 3, this candidate aims to extend the substantial reductions in disease that existing vaccines have achieved. If successful, it could help provide children with the broadest protection against invasive pneumococcal disease to date.”

— Annaliesa Anderson, Ph.D., Senior Vice President and Chief Vaccines Officer, Pfizer

Phase 2 Study Results Across 25 Serotypes

The Phase 2 study is evaluating the safety, tolerability, and immunogenicity of the 25-valent vaccine candidate(25vPnC) compared with PREVNAR 20 in healthy infants. These data build on results announced earlier this year showing:

Robust immune responses against all 25 serotypes one month after Dose 3 and one month after Dose 4, including against all five new serotypes (15A, 23A, 23B, 24F, and 35B).^{Rates of local reactions, systemic events, and adverse events were balanced across the 25-valent vaccine candidate and PREVNAR 20 groups in the Phase 2 trial. Adverse events were consistent with conditions commonly diagnosed in this age group. There were no related serious adverse events identified in the study. ¹}

The 25-valent vaccine candidate elicited an enhanced immune response against serotype 3 compared with PREVNAR 20, generating GMCs that were 8.8-fold higher one month after Dose 3 and approximately 15-fold higher one month after Dose 4. ¹It utilizes next-generation technology specifically designed to elicit a more robust immune response against serotype 3, which accounts for 10.6% of all IPD in children under five years old in the U.S. ²

25-valent vaccine candidate also elicited functional responses in the opsonophagocytic activity assay (OPA) one month after Dose 4 for all 25 target serotypes, demonstrating booster effects. ¹This result demonstrates the vaccine candidate’s potential to generate antibodies that can contribute to the functional killing of pneumococcal bacteria.³

Detailed results from the presentation can be found online here.

Continuing Pfizer’s Commitment to Pneumococcal Disease Prevention

These results build on Pfizer’s long-standing commitment to protecting people from pneumococcal disease. Pfizer is advancing two next-generation pneumococcal conjugate vaccine candidates across pediatric and adult populations.

In children, 25vPnC is being evaluated in three Phase 3 studies that began earlier in 2026, with up to 6,830 participants randomized to receive 25vPnC or PREVNAR 20.^4,5,6Additionally, Pfizer has completed enrollment of a Phase 3 study to demonstrate the consistency of three manufacturing lots of 25vPnC.⁷

The five new serotypes (15A, 23A, 23B, 24F, and 35B) are estimated to account for an additional ~30% of pediatric invasive pneumococcal disease cases in the U.S. compared with PREVNAR 20.² It also uses next-generation technology designed to improve responses to serotype 3, which accounts for 10.6% of invasive pneumococcal disease in U.S. children under five years of age.^1,2

In adults, Pfizer plans to bring a fifth-generation, 35-valent vaccine candidate into clinical development by the end of 2026, pending alignment from regulatory authorities.

For more information on Pfizer’s Commitment to Vaccines, please visit: Vaccines | Pfizer | Pfizer. More information on Pfizer’s overall presence at IDWeek 2026 is here.

U.S. INDICATION AND IMPORTANT SAFETY INFORMATION FOR PREVNAR 20

INDICATION

PREVNAR 20 is a vaccine approved for:

the prevention of invasive disease caused by 20 Streptococcus pneumoniae strains (1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F) in individuals 6 weeks of age and older.

the prevention of otitis media (middle ear infection) caused by 7 of the 20 strains in individuals 6 weeks through 5 years.

active immunization for the prevention of pneumonia caused by Streptococcus pneumoniae strains 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 18 years of age and older.

The indication for the prevention of pneumonia caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F in individuals 18 years of age and older is approved based on immune responses. Continued approval may depend on a supportive study.

IMPORTANT SAFETY INFORMATION

PREVNAR 20 should not be given to anyone who has had a severe allergic reaction to any component of Prevnar 20 or to diphtheria toxoid.

Individuals with weakened immune systems may have a lower immune response. Safety data are not available for these groups.

A temporary pause in breathing after getting a vaccine has been observed in some infants who were born prematurely. For premature infants, talk to your healthcare provider about the infant’s medical status when deciding to get vaccinated with Prevnar 20.

In individuals 2, 4, 6, and 12 through 15 months of age vaccinated with a 4-dose schedule, the most common side effects reported at a rate of >10% were irritability, pain at the injection site, drowsiness, decreased appetite, injection site redness, injection site swelling, and fever.

In individuals 15 months through 17 years of age vaccinated with a single dose, the most common side effects reported at a rate of >10% were irritability, pain at the injection site, drowsiness, fatigue, muscle pain, decreased appetite, injection site swelling, injection site redness, headache, and fever.

In individuals 18 years and older, the most common side effects reported at a rate of >10% were pain at the injection site, muscle pain, fatigue, headache, and joint pain. Also, injection site swelling was common in individuals 18 years through 59 years of age.

Ask your healthcare provider about the risks and benefits of Prevnar 20. Only a healthcare provider can decide if PREVNAR 20 is right for you or your child.

Please click for PREVNAR 20 Full Prescribing Information.

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our websiteatwww.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at www.facebook.com/Pfizer/.

Disclosure Notice

The information contained in this release is as of October 24, 2026. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about an investigational pediatric 25-valent pneumococcal conjugate vaccine candidate PF-07872412 (25vPnC) and an investigational adult fifth-generation, 35-valent vaccine candidate vaccine candidate (35vPnC), including their potential benefits, results from a Phase 2 study of 25vPvC in infants and clinical development plans and timing for 25vPnC and 35vPnC, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with initial, preliminary or interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when applications may be filed in any jurisdictions for 25vPnC or 35vPnC; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether 25vPnC and 35vPnC will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of 25vPnC and 35vPnC; uncertainties regarding the ability to obtain or maintain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; risks and uncertainties related to changes to vaccine or other healthcare policy in the U.S.; challenges related to public vaccine confidence or awareness; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws or regulations; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

References

Smith M, Flint L, Trammel J, et al. Immunogenicity of a 25-Valent Pneumococcal Coverage Vaccine Compared with PCV20 in Healthy Infants: Evaluating A Candidate to Improve Pneumococcal Coverage in a Phase 2 Trial. Presented at IDWeek 2026; October 24, 2026; Washington DC.

Centers for Disease Control and Prevention. Surveillance Reports, 2020-2024. Active Bacterial Core surveillance (ABCs). Accessed October 12, 2026. https://www.cdc.gov/abcs/reports/index.html

Paschall AV, Middleton DR, Avci FY. Opsonophagocytic Killing Assay to Assess Immunological Responses Against Bacterial Pathogens. J Vis Exp. 2019;(146):10.3791/59400.

ClinicalTrials.gov. A Study to Learn About How a New Pneumococcal Vaccine Works in Infants. Updated September 8, 2026. Accessed October 12, 2026. https://clinicaltrials.gov/study/NCT07629440

ClinicalTrials.gov. A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants. Updated September 15, 2026. Accessed October 12, 2026. https://clinicaltrials.gov/study/NCT07573462

ClinicalTrials.gov. Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and Adolescents (NCT07660198). Updated August 31, 2026. Accessed October 12, 2026. https://clinicaltrials.gov/study/NCT07660198

ClinicalTrials.gov. A Study to Assess the Safety, Tolerability, and Immunogenicity of 3 Lots of a Multivalent Pneumococcal Conjugate Vaccine Administered to Adults. Updated September 23, 2026. Accessed October 12, 2026. https://clinicaltrials.gov/study/NCT07794748

View source version on businesswire.com: https://www.businesswire.com/news/home/20261024078788/en/

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Posted on October 24, 2026 10:38 am
IMFINZI® (durvalumab)plus tarlatamab-dlle reduced the risk of death by 58% in 1st-line extensive-stage small cell lung cancer in the DeLLphi-305 Phase III trial

IMFINZI^® (durvalumab)plus tarlatamab-dlle reduced the risk of death by 58% in 1st-line extensive-stage small cell lung cancer in the DeLLphi-305 Phase III trial

Novel combination demonstrated a median overall survival of nearly two years, the longest benefit ever reported in extensive stage disease in a Phase III trial

Results reinforce IMFINZI as the backbone immunotherapy across stages of small cell lung cancer

WILMINGTON, Del.–(BUSINESS WIRE)–
Landmark results from the DeLLphi-305 Phase III trial showed IMFINZI^® (durvalumab) plus Amgen’s tarlatamab-dlle demonstrated a statistically significant and highly clinically meaningful improvement in the primary endpoint of overall survival (OS) and in the key secondary endpoint of progression-free survival (PFS) versus IMFINZI alone as a 1st-line maintenance treatment. The trial included patients with extensive-stage small cell lung cancer (ES-SCLC) who had not progressed following standard induction treatment with IMFINZI plus platinum chemotherapy (investigator’s choice of carboplatin or cisplatin) and etoposide.

These results will be presented today in a Proffered Paper session during Presidential Symposium I at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain (abstract #LBA3).¹ They were also simultaneously published in The New England Journal of Medicine.

In a planned interim analysis, IMFINZI plus tarlatamab-dlle reduced the risk of death by 58% compared to IMFINZI alone (based on an OS hazard ratio [HR] of 0.42; 95% confidence interval [CI] 0.32-0.54; p<0.001) at a median follow-up of approximately 16 months. Median OS was 21.1 months for the combination versus 12.7 months for IMFINZI alone. An estimated 79% of patients treated with the combination were alive at one year compared to 53% for IMFINZI alone.

Results from the key secondary endpoint of PFS showed the combination reduced the risk of disease progression or death by 66% compared to IMFINZI alone (based on a PFS HR of 0.34; 95% CI 0.28-0.42; p<0.001) at a median follow-up of 13.9 months. Median PFS was 7.4 months for the combination versus 1.9 months for IMFINZI alone. An estimated 38% of patients treated with the combination were alive and had not experienced disease progression at one year compared to 10% for IMFINZI alone.

The OS and PFS benefits observed were consistent across all prespecified subgroups, including patients with brain or liver metastases.

Confirmed objective response rate (ORR) with the combination was six times higher compared to IMFINZI alone (26.4% versus 4.1%; p<0.001). Median duration of response (DOR) for the combination exceeded 1 year (12.7 months) versus 5.6 months for IMFINZI alone.

Jacob Sands, MD, Associate Chief of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute and international coordinating investigator for the trial, said: “For a disease where durable survival has remained extremely difficult to achieve, the magnitude and consistency of benefit in DeLLphi-305 are striking. Importantly, the benefit was seen across clinically relevant groups, including patients with brain metastases. Today’s remarkable results demonstrate substantial progress in our work to achieve meaningfully longer disease control and survival for patients with extensive-stage small cell lung cancer, further highlighting the importance of effective treatment at the earliest possible opportunity.”

Leora Horn, Senior Vice President, Late Development Oncology, Oncology R&D, AstraZeneca, said: “IMFINZI-based induction therapy followed by maintenance treatment with IMFINZI plus tarlatamab-dlle will redefine treatment standards for patients with extensive-stage small cell lung cancer. As the only immunotherapy to demonstrate a significant survival benefit across stages of small cell lung cancer, and now the first in combination with a T-cell engager, these important data further reinforce IMFINZI as the backbone immunotherapy in this setting.”

Summary of results: DeLLphi-305ⁱ

IMFINZIplus tarlatamab-dlle

(n=282)

IMFINZI

(n=281)

OS

Median OS (95% CI) (in months)

21.1

(20.8-NEⁱⁱ)

12.7

(11.2-14.8)

HR (95% CI)

0.42

(0.32-0.54)

Stratified log-rank, 2-sided p-value

p<0.001

OS rate at 12 months (%)

79

53

Median follow-up (in months)

15.9

16.1

PFS

Median PFS (95% CI) (in months)

7.4

(5.6-9.1)

1.9

(1.9-2.0)

HR (95% CI)

0.34

(0.28-0.42)

Stratified log-rank, 2-sided p-value

p<0.001

PFS rate at 12 months (%)

38

10

Median follow-up (in months)

13.9

13.9

IMFINZI plus tarlatamab-dlle

(n=235)

IMFINZI

(n=244)

BORⁱⁱⁱ % (n)

Confirmed complete response^iv

0.9 (2)

0.4 (1)

Confirmed partial response^iv

25.5 (60)

3.7 (9)

Stable disease

54.0 (127)

30.3 (74)

Progressive disease

18.3 (43)

61.5 (150)

ORR

Confirmed ORR (%) (95% CI)

26.4

(20.9-32.5)

4.1

(2.0-7.4)

2-sided p-value

p<0.001

Median DOR in months (95% CI)

12.7

(7.4-NE)

5.6

(3.5-NE)

DOR rate at 12 months (%)

52

0

Remaining on treatment as of data cut-offⁱ (%)

43.6

11.4

Median follow-up (in months)

10.2

8.3

IMFINZI plus tarlatamab-dlle

(n=282)

IMFINZI

(n=278)

Median duration of treatment, weeks (IQR^v)

46.9 (16.4-65.6)

8.1 (4.1-20.1)

Data cut-off was July 7, 2026

Not estimable

Best overall response: Objective response was assessed in patients with measurable disease at randomization (after chemoimmunotherapy) (mITT Analysis Set) by Investigator. Events were based on RECIST 1.1 guidelines; complete response and partial response should be confirmed responses. Postbaseline scan data not available for 3 (1.3%) patients who received the IMFINZI combination and 10 (4.1%) who received IMFINZI alone.

Confirmation of a complete response (CR) or a partial response (PR) was required and had to take place no fewer than 4 weeks after the initial documentation of a CR or a PR.

Interquartile range.

The safety and tolerability of IMFINZI plus tarlatamab-dlle was consistent with the known safety profiles of the individual medicines. Grade 3 and 4 treatment-related adverse events related to any treatment occurred in 20.9% of patients treated with the combination and 10.8% of patients treated with IMFINZI alone. Treatment with the combination resulted in a low frequency of treatment discontinuations and no treatment-related fatalities.

IMPORTANT SAFETY INFORMATION

There are no contraindications for IMFINZI^® (durvalumab) or IMJUDO^® (tremelimumab-actl).

Severe and Fatal Immune-Mediated Adverse Reactions

Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue IMFINZI and IMJUDO depending on severity. See USPI Dosing and Administration for specific details. In general, if IMFINZI and IMJUDO requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.

Immune-Mediated Pneumonitis

IMFINZI and IMJUDO can cause immune-mediated pneumonitis, which may be fatal. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation.

IMFINZI as a Single Agent

In patients who did not receive recent prior radiation, the incidence of immune-mediated pneumonitis was 2.4% (34/1414), including fatal (<0.1%), and Grade 3-4 (0.4%) adverse reactions.

In patients who received recent prior radiation, the incidence of pneumonitis (including radiation pneumonitis) in patients with unresectable Stage III NSCLC following definitive chemoradiation within 42 days prior to initiation of IMFINZI in PACIFIC was 18.3% (87/475) in patients receiving IMFINZI and 12.8% (30/234) in patients receiving placebo. Of the patients who received IMFINZI (475), 1.1% were fatal and 2.7% were Grade 3 adverse reactions.

The incidence of pneumonitis (including radiation pneumonitis) in patients with LS-SCLC following chemoradiation within 42 days prior to initiation of IMFINZI in ADRIATIC was 14% (37/262) in patients receiving IMFINZI and 6% (16/265) in patients receiving placebo. Of the patients who received IMFINZI (262), 0.4% had a fatal adverse reaction and 2.7% had Grade 3 adverse reactions.

The frequency and severity of immune-mediated pneumonitis in patients who did not receive definitive chemoradiation prior to IMFINZI were similar in patients who received IMFINZI as a single agent or with ES-SCLC or BTC when given in combination with chemotherapy.

IMFINZI with IMJUDO

Immune‑mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions.

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

Immune-mediated pneumonitis occurred in 3.5% (21/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.5%), and Grade 3 (1%) adverse reactions.

Immune-Mediated Colitis

IMFINZI with IMJUDO and platinum-based chemotherapy can cause immune-mediated colitis, which may be fatal. IMFINZI and IMJUDO can cause immune-mediated colitis that is frequently associated with diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies.

IMFINZI as a Single Agent

Immune-mediated colitis occurred in 2% (37/1889) of patients receiving IMFINZI, including Grade 4 (<0.1%) and Grade 3 (0.4%) adverse reactions.

IMFINZI with IMJUDO

Immune‑mediated colitis or diarrhea occurred in 6% (23/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (3.6%) adverse reactions. Intestinal perforation has been observed in other studies of IMFINZI and IMJUDO.

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

Immune-mediated colitis occurred in 6.5% (39/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including fatal (0.2%) and Grade 3 (2.5%) adverse reactions. Intestinal perforation and large intestine perforation were reported in 0.1% of patients.

Immune-Mediated Hepatitis

IMFINZI and IMJUDO can cause immune-mediated hepatitis, which may be fatal.

IMFINZI as a Single Agent

Immune-mediated hepatitis occurred in 2.8% (52/1889) of patients receiving IMFINZI, including fatal (0.2%), Grade 4 (0.3%) and Grade 3 (1.4%) adverse reactions.

IMFINZI with IMJUDO

Immune‑mediated hepatitis occurred in 7.5% (29/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.8%), Grade 4 (0.3%) and Grade 3 (4.1%) adverse reactions.

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

Immune-mediated hepatitis occurred in 3.9% (23/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.3%), Grade 4 (0.5%), and Grade 3 (2%) adverse reactions.

Immune-Mediated Endocrinopathies

Adrenal Insufficiency:IMFINZI and IMJUDO can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated.

IMFINZI as a Single Agent

Immune-mediated adrenal insufficiency occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.

IMFINZI with IMJUDO

Immune-mediated adrenal insufficiency occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

Immune-mediated adrenal insufficiency occurred in 2.2% (13/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.8%) adverse reactions.

Thyroid Disorders:IMFINZI and IMJUDO can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement therapy for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated.

IMFINZI as a Single Agent

Immune-mediated thyroiditis occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.

Immune-mediated hyperthyroidism occurred in 2.1% (39/1889) of patients receiving IMFINZI.

Immune-mediated hypothyroidism occurred in 8.3% (156/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.

IMFINZI with IMJUDO

Immune-mediated thyroiditis occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO.

Immune-mediated hyperthyroidism occurred in 4.6% (18/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.

Immune-mediated hypothyroidism occurred in 11% (42/388) of patients receiving IMFINZI and IMJUDO.

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

Immune-mediated thyroiditis occurred in 1.2% (7/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy.

Immune-mediated hyperthyroidism occurred in 5% (30/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions.

Immune-mediated hypothyroidism occurred in 8.6% (51/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions.

IMFINZI with Carboplatin and Paclitaxel

Immune-mediated hypothyroidism occurred in 14% (34/235) of patients receiving IMFINZI in combination with carboplatin and paclitaxel.

Type 1 Diabetes Mellitus, which can present with diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated.

IMFINZI as a Single Agent

Grade 3 immune-mediated Type 1 diabetes mellitus occurred in <0.1% (1/1889) of patients receiving IMFINZI.

IMFINZI with IMJUDO

Two patients (0.5%, 2/388) had events of hyperglycemia requiring insulin therapy that had not resolved at last follow-up.

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

Immune-mediated Type 1 diabetes mellitus occurred in 0.5% (3/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including Grade 3 (0.3%) adverse reactions.

Immune-Mediated Nephritis with Renal Dysfunction

IMFINZI and IMJUDO can cause immune-mediated nephritis.

IMFINZI as a Single Agent

Immune-mediated nephritis occurred in 0.5% (10/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.

IMFINZI with IMJUDO

Immune-mediated nephritis occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.5%) adverse reactions.

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

Immune-mediated nephritis occurred in 0.7% (4/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions.

Immune-Mediated Dermatology Reactions

IMFINZI and IMJUDO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson Syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), has occurred with PD-1/L-1 and CTLA-4 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes.

IMFINZI as a Single Agent

Immune-mediated rash or dermatitis occurred in 1.8% (34/1889) of patients receiving IMFINZI, including Grade 3 (0.4%) adverse reactions.

IMFINZI with IMJUDO

Immune-mediated rash or dermatitis occurred in 4.9% (19/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions.

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

Immune-mediated rash or dermatitis occurred in 7.2% (43/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.3%) adverse reactions.

Immune-Mediated Pancreatitis

IMFINZI in combination with IMJUDO can cause immune-mediated pancreatitis. Immune-mediated pancreatitis occurred in 2.3% (9/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions.

Other Immune-Mediated Adverse Reactions

The following clinically significant, immune-mediated adverse reactions occurred at an incidence of less than 1% each in patients who received IMFINZI and IMJUDO or were reported with the use of other immune-checkpoint inhibitors.

Cardiac/vascular: Myocarditis, pericarditis, vasculitis.

Nervous system: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy.

Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss.

Gastrointestinal: Pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis.

Musculoskeletal and connective tissue disorders: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatica.

Endocrine: Hypoparathyroidism.

Hematologic/Immune: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection, other transplant (including corneal graft) rejection.

Other: Myocarditis-Myositis-Myasthenia Gravis (or Myasthenia-Like) Overlap Syndrome, reported as the co-occurrence of either two or all three adverse reactions

Infusion-Related Reactions

IMFINZI and IMJUDO can cause severe or life-threatening infusion-related reactions. Monitor for signs and symptoms of infusion-related reactions. Interrupt, slow the rate of, or permanently discontinue IMFINZI and IMJUDO based on the severity. See USPI Dosing and Administration for specific details. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses.

IMFINZI as a Single Agent

Infusion-related reactions occurred in 2.2% (42/1889) of patients receiving IMFINZI, including Grade 3 (0.3%) adverse reactions.

IMFINZI with IMJUDO

Infusion-related reactions occurred in 2.6% (10/388) of patients receiving IMFINZI and IMJUDO.

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

Infusion-related reactions occurred in 2.9% (17/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.3%) adverse reactions.

Complications of Allogeneic HSCT after IMFINZI

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/L-1 blocking antibody. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/L-1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an allogeneic HSCT.

Embryo-Fetal Toxicity

Based on their mechanism of action and data from animal studies, IMFINZI and IMJUDO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. In females of reproductive potential, verify pregnancy status prior to initiating IMFINZI and IMJUDO and advise them to use effective contraception during treatment with IMFINZI and IMJUDO and for 3 months after the last dose of IMFINZI and IMJUDO.

Lactation

There is no information regarding the presence of IMFINZI and IMJUDO in human milk; however, because of the potential for serious adverse reactions in breastfed infants from IMFINZI and IMJUDO, advise women not to breastfeed during treatment and for 3 months after the last dose.

Adverse Reactions

Unresectable Stage III NSCLC

In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), the most common adverse reactions (≥20%) were cough (40%), fatigue (34%), pneumonitis or radiation pneumonitis (34%), upper respiratory tract infections (26%), dyspnea (25%), and rash (23%). The most common Grade 3 or 4 adverse reactions (≥3%) were pneumonia (7%) and pneumonitis/radiation pneumonitis (3.4%).

In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), discontinuation due to adverse reactions occurred in 15% of patients in the IMFINZI arm. Serious adverse reactions occurred in 29% of patients receiving IMFINZI. The most frequent serious adverse reactions (≥2%) were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%). Fatal pneumonitis or radiation pneumonitis and fatal pneumonia occurred in <2% of patients and were similar across arms.

Resectable NSCLC

In patients with resectable NSCLC in the AEGEAN study, the most common adverse reactions (occurring in ≥20% of patients) were anemia, nausea, constipation, fatigue, musculoskeletal pain, and rash.

In patients with resectable NSCLC in the neoadjuvant phase of the AEGEAN study receiving IMFINZI in combination with platinum-containing chemotherapy (n=401), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 6.7% of patients. Serious adverse reactions occurred in 21% of patients. The most frequent (≥1%) serious adverse reactions were pneumonia (2.7%), anemia (1.5%), myelosuppression (1.5%), vomiting (1.2%), neutropenia (1%), and acute kidney injury (1%). Fatal adverse reactions occurred in 2% of patients, including death due to COVID-19 pneumonia (0.5%), sepsis (0.5%), myocarditis (0.2%), decreased appetite (0.2%), hemoptysis (0.2%), and death not otherwise specified (0.2%). Of the 401 IMFINZI-treated patients who received neoadjuvant treatment and 398 placebo-treated patients who received neoadjuvant treatment, 1.7% (n=7) and 1% (n=4), respectively, did not receive surgery due to adverse reactions.

In patients with resectable NSCLC in the adjuvant phase of the AEGEAN study receiving IMFINZI as a single agent (n=265), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 8% of patients. Serious adverse reactions occurred in 13% of patients. The most frequent serious adverse reactions reported in >1% of patients were pneumonia (1.9%), pneumonitis (1.1%), and COVID-19 (1.1%). Four fatal adverse reactions occurred during the adjuvant phase of the study, including COVID-19 pneumonia, pneumonia aspiration, interstitial lung disease and aortic aneurysm.

Metastatic NSCLC

In patients with mNSCLC in the POSEIDON study receiving IMFINZI and IMJUDO plus platinum-based chemotherapy (n=330), the most common adverse reactions (occurring in ≥20% of patients) were nausea (42%), fatigue (36%), musculoskeletal pain (29%), decreased appetite (28%), rash (27%), and diarrhea (22%).

In patients with mNSCLC in the POSEIDON study receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy (n=330), permanent discontinuation of IMFINZI or IMJUDO due to an adverse reaction occurred in 17% of patients. Serious adverse reactions occurred in 44% of patients, with the most frequent serious adverse reactions reported in at least 2% of patients being pneumonia (11%), anemia (5%), diarrhea (2.4%), thrombocytopenia (2.4%), pyrexia (2.4%), and febrile neutropenia (2.1%). Fatal adverse reactions occurred in a total of 4.2% of patients.

Limited-stage Small Cell Lung Cancer

In patients with limited-stage SCLC in the ADRIATIC study receiving IMFINZI (n=262), the most common adverse reactions occurring in ≥20% of patients receiving IMFINZI were pneumonitis or radiation pneumonitis (38%), and fatigue (21%). The most common Grade 3 or 4 adverse reactions (≥3%) were pneumonitis or radiation pneumonitis and pneumonia.

In patients with limited-stage SCLC in the ADRIATIC study receiving IMFINZI (n=262), IMFINZI was permanently discontinued due to adverse reactions in 16% of the patients receiving IMFINZI. Serious adverse reactions occurred in 30% of patients receiving IMFINZI. The most frequent serious adverse reactions reported in ≥1% of patients receiving IMFINZI were pneumonitis or radiation pneumonitis (12%), and pneumonia (5%). Fatal adverse reactions occurred in 2.7% of patients who received IMFINZI including pneumonia (1.5%), cardiac failure, encephalopathy and pneumonitis (0.4% each).

Extensive-stage Small Cell Lung Cancer

In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), the most common adverse reactions (≥20%) were nausea (34%), fatigue/asthenia (32%), and alopecia (31%). The most common Grade 3 or 4 adverse reaction (≥3%) was fatigue/asthenia (3.4%).

In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), IMFINZI was discontinued due to adverse reactions in 7% of the patients receiving IMFINZI plus chemotherapy. Serious adverse reactions occurred in 31% of patients receiving IMFINZI plus chemotherapy. The most frequent serious adverse reactions reported in at least 1% of patients were febrile neutropenia (4.5%), pneumonia (2.3%), anemia (1.9%), pancytopenia (1.5%), pneumonitis (1.1%), and COPD (1.1%). Fatal adverse reactions occurred in 4.9% of patients receiving IMFINZI plus chemotherapy.

Locally Advanced or Metastatic Biliary Tract Cancers (BTCs)

In patients with locally advanced or metastatic BTCs in the TOPAZ-1 study receiving IMFINZI (n=338), the most common adverse reactions (occurring in ≥20% of patients) were fatigue (42%), nausea (40%), constipation (32%), decreased appetite (26%), abdominal pain (24%), rash (23%), and pyrexia (20%).

In patients with locally advanced or metastatic BTCs in the TOPAZ-1 study receiving IMFINZI (n=338), discontinuation due to adverse reactions occurred in 6% of the patients receiving IMFINZI plus chemotherapy. Serious adverse reactions occurred in 47% of patients receiving IMFINZI plus chemotherapy. The most frequent serious adverse reactions reported in at least 2% of patients were cholangitis (7%), pyrexia (3.8%), anemia (3.6%), sepsis (3.3%), and acute kidney injury (2.4%). Fatal adverse reactions occurred in 3.6% of patients receiving IMFINZI plus chemotherapy. These include ischemic or hemorrhagic stroke (4 patients), sepsis (2 patients), and upper gastrointestinal hemorrhage (2 patients).

Unresectable Hepatocellular Carcinoma (HCC)

In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and IMJUDO (n=388), the most common adverse reactions (occurring in ≥20% of patients) were rash (32%), diarrhea (27%), fatigue (26%), pruritus (23%), musculoskeletal pain (22%), and abdominal pain (20%).

In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and IMJUDO (n=388), serious adverse reactions occurred in 41% of patients. Serious adverse reactions in >1% of patients included hemorrhage (6%), diarrhea (4%), sepsis (2.1%), pneumonia (2.1%), rash (1.5%), vomiting (1.3%), acute kidney injury (1.3%), and anemia (1.3%). Fatal adverse reactions occurred in 8% of patients who received IMFINZI and IMJUDO, including death (1%), hemorrhage intracranial (0.5%), cardiac arrest (0.5%), pneumonitis (0.5%), hepatic failure (0.5%), and immune-mediated hepatitis (0.5%). Permanent discontinuation of treatment regimen due to an adverse reaction occurred in 14% of patients.

Primary Advanced or Recurrent dMMR Endometrial Cancer

In patients with primary advanced or recurrent dMMR endometrial cancer in the DUO-E study receiving IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent (n=44), the most common adverse reactions, including laboratory abnormalities (occurring in >20% of patients) were peripheral neuropathy (61%), musculoskeletal pain (59%), nausea (59%), alopecia (52%), fatigue (41%), abdominal pain (39%), constipation (39%), rash (39%), decreased magnesium (36%), increased ALT (32%), increased AST (30%), diarrhea (27%), vomiting (27%), cough (27%), decreased potassium (25%), dyspnea (25%), headache (23%), increased alkaline phosphatase (20%), and decreased appetite (18%). The most common Grade 3 or 4 adverse reactions (≥3%) were constipation (4.5%) and fatigue (4.5%).

In patients with primary advanced or recurrent dMMR endometrial cancer in the DUO-E study receiving IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent (n=44), permanent discontinuation of IMFINZI due to adverse reactions occurred in 11% of patients. Serious adverse reactions occurred in 30% of patients who received IMFINZI with carboplatin and paclitaxel; the most common serious adverse reactions (≥4%) were constipation (4.5%) and rash (4.5%).

BCG-Naive, High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC)

In patients with BCG-naive, HR-NMIBC in the POTOMAC study receiving IMFINZI in combination with BCG, the most common (≥20%) adverse reactions, including laboratory abnormalities were increased glucose (43%), increased AST (43%), increased lipase (42%), increased ALT (42%), increased GGT (40%), urinary tract infection (40%), increased potassium (39%), dysuria (37%), decreased hemoglobin (35%), hematuria (33%), increased serum creatinine (30%), musculoskeletal pain (28%), decreased lymphocytes (27%), urinary frequency (26%), decreased sodium (23%), fatigue (21%), rash (20%), and pyrexia (20%).

In patients with BCG-naive, HR-NMIBC in the POTOMAC study receiving IMFINZI in combination with BCG, permanent discontinuation of IMFINZI due to adverse reactions occurred in 18% of patients. The adverse reactions which resulted in permanent discontinuation of IMFINZI (≥1%) were hepatitis (1.8%), acute kidney injury (1.2%), and diarrhea (1.2%). Serious adverse reactions occurred in 32% of patients. The most common (≥1%) serious adverse reactions were urinary tract infection (4.5%), COVID (1.8%), hepatitis (1.5%), dysuria (1.2%), and prostate cancer (1.2%). Fatal adverse reactions occurred in 2.4% of patients who received IMFINZI in combination with BCG, including congestive cardiac failure (0.6%), COVID (0.3%), cardiovascular disorder (0.3%), dementia with Lewy bodies (0.3%), and pancreatic cancer (0.3%).

Muscle-Invasive Bladder Cancer (MIBC)

In patients with MIBC, the most common adverse reactions, including laboratory abnormalities, in the overall study (occurring in ≥20% of patients) were decreased hemoglobin, decreased neutrophils, increased blood creatinine, decreased sodium, nausea, increased ALT, decreased calcium, decreased platelets, fatigue, increased potassium, decreased lymphocytes, increased AST, constipation, decreased magnesium, decreased appetite, increased alkaline phosphatase, rash, pyrexia, diarrhea, vomiting and abdominal pain.

In patients with MIBC in the neoadjuvant phase of the NIAGARA study receiving IMFINZI in combination with gemcitabine and cisplatin (n=530), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 9% of patients. Serious adverse reactions occurred in 24% of patients; the most frequent (≥1%) serious adverse reactions were pulmonary embolism (1.9%), febrile neutropenia (1.5%), acute kidney injury (1.3%), thrombocytopenia (1.3%), urinary tract infection (1.3%), and pneumonia (1.3%). Fatal adverse reactions occurred in 1.1% of patients including sepsis, myocardial infarction, and pulmonary embolism (0.2% each). One fatal adverse reaction of pneumonia was reported in 1 (0.2%) patient in the post-surgery phase before adjuvant treatment started. Of the 530 patients in the IMFINZI treatment arm and 526 patients in the chemotherapy treatment arm who received neoadjuvant treatment, 1 (0.2%) patient in each treatment arm did not receive surgery due to adverse reactions. The adverse reaction that led to cancellation of surgery in the IMFINZI treatment arm was interstitial lung disease.

In patients with MIBC in the adjuvant phase of the NIAGARA study receiving IMFINZI as a single agent (n=383), permanent discontinuation of adjuvant IMFINZI due to an adverse reaction occurred in 5% of patients. Serious adverse reactions occurred in 26% of patients. The most frequent serious adverse reactions (occurring in ≥1% of patients) were urinary tract infection (7%), acute kidney injury (3.7%), hydronephrosis (2.1%), pyelonephritis (2.1%), urosepsis (1.8%) and sepsis (1.6%). Fatal adverse reactions occurred in 1.8% of patients, including COVID-19, severe acute respiratory syndrome, cardiopulmonary failure, gastrointestinal hemorrhage, and chronic hepatic failure (0.3% each).

Resectable Gastric Cancer/Gastroesophageal Junction Adenocarcinoma (GC/GEJC)

In patients with resectable GC/GEJC, the most common adverse reactions in the overall study (occurring in ≥20% of patients) were diarrhea, nausea, peripheral neuropathy, fatigue, alopecia, decreased appetite, rash, abdominal pain, vomiting, musculoskeletal pain, pyrexia, and stomatitis.

In patients with resectable GC/GEJC in the neoadjuvant phase of the MATTERHORN study receiving IMFINZI in combination with FLOT chemotherapy (n=475), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 2.5% of patients. Serious adverse reactions occurred in 21% of patients; the most frequent (≥2%) serious adverse reaction was diarrhea (2.5%). Deaths occurred in 1.9% of patients; deaths of ≥2 patients included septic shock (0.6%) and acute coronary syndrome (0.4%). Of the 475 patients in the IMFINZI + FLOT chemotherapy treatment arm and 469 patients in the placebo + FLOT chemotherapy treatment arm who received neoadjuvant treatment, 0.6% and 0.4% of patients, respectively, did not receive surgery due to adverse reactions, and 2.3% and 2.6% of patients, respectively, had a delay in surgery due to ARs.

In patients with resectable GC/GEJC in the adjuvant phase of the MATTERHORN study receiving IMFINZI in combination with FLOT chemotherapy (n=365), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 7% of patients. Serious adverse reactions occurred in 29% of patients; the most frequent (≥2%) serious adverse reaction was pneumonia (2.5%). Deaths occurred in 2.2% of patients; deaths of ≥2 patients included gastrointestinal perforation (0.5%) and COVID-19 (0.5%).

In patients with resectable GC/GEJC in the adjuvant phase of the MATTERHORN study receiving IMFINZI alone (n=345), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 6% of patients. Serious adverse reactions occurred in 14% of patients. Deaths occurred in 1.7% of patients; deaths of ≥2 patients included gastrointestinal perforation (0.6%) and COVID-19 (0.6%).

The safety and effectiveness of IMFINZI and IMJUDO have not been established in pediatric patients.

Indications:

IMFINZI, as a single agent, is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).

IMFINZI in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, is indicated for the treatment of adult patients with resectable (tumors ≥4 cm and/or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.

IMFINZI, in combination with IMJUDO and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations.

IMFINZI, as a single agent, is indicated for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).

IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

IMFINZI, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC).

IMFINZI in combination with IMJUDO is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).

IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) as determined by an FDA-authorized test.

IMFINZI in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-naive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC).

IMFINZI in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent IMFINZI as adjuvant treatment following radical cystectomy, is indicated for the treatment of adult patients with muscle-invasive bladder cancer (MIBC).

IMFINZI in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) as neoadjuvant and adjuvant treatment, followed by single agent IMFINZI, is indicated for the treatment of adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).

Please see Full Prescribing Information including Medication Guide for IMFINZI and IMJUDO.

Notes

Small cell lung cancer

Lung cancer is the leading cause of cancer death globally, accounting for almost one in five (19%) cancer deaths.^2,3 Lung cancer is broadly split into non-small cell lung cancer (NSCLC) and SCLC, with about 15% classified as SCLC.⁴

About two-thirds of SCLC patients are diagnosed with ES-SCLC, a highly aggressive, fast-growing form of lung cancer characterized by rapid tumor progression and metastatic spread to organs such as the brain and liver.⁵ In 2026, an estimated 195,000 people globally will be treated for ES-SCLC.⁶

Immune checkpoint inhibitors such as IMFINZIhave led to significant improvements in OS in ES-SCLC, establishing a 1st-line standard of care. However, many patients still experience disease progression due to the aggressive nature of the disease, and median OS with the current standard of care is approximately one year.⁵ Only 18.1% of limited-stage SCLC patients and 3.6% of ES-SCLC patients are alive five years after diagnosis.⁷

DeLLphi-305

The DeLLphi-305 trial is sponsored by Amgen, with partial funding and IMFINZI provided by AstraZeneca. It is a global Phase III, randomized, open-label clinical trial evaluating the efficacy and safety of IMFINZI in combination with tarlatamab-dlle compared to IMFINZI alone as 1st-line maintenance treatment for patients with ES-SCLC who have not progressed following induction treatment with IMFINZI in combination with platinum chemotherapy and etoposide.

Tarlatamab-dlle is a first-in-class targeted immunotherapy that binds to both DLL3 on tumor cells and CD3 on T cells, thereby activating T cells to kill DLL3-expressing SCLC cells. DLL3 is a protein that is expressed on the surface of SCLC cells in ~85-96% of patients with SCLC, but is minimally expressed on healthy cells.

In the trial, 563 patients who completed IMFINZI -based induction treatment were randomized 1:1 to receive either IMFINZI in combination with tarlatamab-dlle or IMFINZI alone until progression or unacceptable toxicity. Following tarlatamab-dlle infusion on Cycle 1 Day 1 and Cycle 1 Day 8, patients were monitored in a healthcare setting for 1 to 2 hours (6 to 8 hours in certain regions including Europe). The trial included patients with both treated and untreated asymptomatic brain metastases at baseline.

The primary endpoint is OS for IMFINZI plus tarlatamab-dlle versus IMFINZI alone. PFS is a key secondary endpoint.

IMFINZI

IMFINZI® (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumor’s immune-evading tactics and releasing the inhibition of immune responses.

IMFINZI is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III NSCLC in patients whose disease has not progressed after chemoradiotherapy (CRT). Additionally, IMFINZI is approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable NSCLC, and in combination with a short course of IMJUDO (tremelimumab) and chemotherapy for the treatment of metastatic NSCLC. IMFINZI is also approved for limited-stage SCLC and in combination with chemotherapy (etoposide and either carboplatin or cisplatin) for the treatment of ES-SCLC.

IMFINZI is also approved in combination with chemotherapy in locally advanced or metastatic biliary tract cancer and in combination with IMJUDO in unresectable hepatocellular carcinoma (HCC). It is also approved as a monotherapy in unresectable HCC in Japan, China and the EU, and in resectable, early-stage and locally advanced gastric and gastroesophageal junction cancers in the US, EU and Japan. Additionally, in April 2026, IMFINZI in combination with IMJUDO, lenvatinib and transarterial chemoembolization (TACE) demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of PFS versus TACE alone for patients with unresectable HCC eligible for embolization in the EMERALD-3 Phase III trial.

In bladder cancer, perioperative IMFINZI in combination with neoadjuvant chemotherapy is approved for cisplatin-eligible muscle-invasive bladder cancer (MIBC)IMFINZI in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy is approved in the US and other countries for patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer. In May 2026, positive high-level results from the VOLGA Phase III trial showed that perioperative treatment with IMFINZI in combination with neoadjuvant enfortumab vedotin (EV) demonstrated statistically significant and clinically meaningful improvements in event-free survival (EFS) and OS in patients with MIBC who were ineligible for or had refused cisplatin-based chemotherapy. In addition, perioperative IMFINZI plus IMJUDO in combination with neoadjuvant EV demonstrated a statistically significant and clinically meaningful improvement in EFS and a favorable trend for OS; however, the OS data were not statistically significant at this planned interim analysis and will be formally reassessed at a subsequent analysis. In July 2026, positive high-level results from the NILE Phase III trial showed IMFINZI plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS versus chemotherapy as 1st-line treatment for patients with PD-L1 high unresectable, locally advanced or metastatic urothelial cancer.

IMFINZI in combination with chemotherapy followed by IMFINZI monotherapy is approved as a 1st-line treatment for primary advanced or recurrent endometrial cancer (mismatch repair deficient disease only in US, EU and China). IMFINZI in combination with chemotherapy followed by olaparib and IMFINZI is approved for patients with mismatch repair proficient advanced or recurrent endometrial cancer in the EU and Japan.

Since the first approval in May 2017, more than 470,000 patients have been treated with IMFINZI. As part of a broad development program, IMFINZI is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with NSCLC, bladder cancer, breast cancer, ovarian cancer and several gastrointestinal cancers.

AstraZeneca in lung cancer

AstraZeneca is working to bring patients with lung cancer closer to cure through the detection and treatment of early-stage disease, while also pushing the boundaries of science to improve outcomes in the resistant and advanced settings. By defining new therapeutic targets and investigating innovative approaches, the Company aims to match medicines to the patients who can benefit most.

The Company’s comprehensive portfolio includes leading lung cancer medicines and the next wave of innovations, including osimertinib and gefitinib;IMFINZI and IMJUDO; fam-trastuzumab deruxtecan-nxki and datopotamab deruxtecan-dlnk in collaboration with Daiichi Sankyo; savolitinib in collaboration with HUTCHMED; as well as a pipeline of potential new medicines and combinations across diverse mechanisms of action.

AstraZeneca is a founding member of the Lung Ambition Alliance, a global coalition working to accelerate innovation and deliver meaningful improvements for people with lung cancer, including and beyond treatment.

AstraZeneca in immuno-oncology (IO)

AstraZeneca is a pioneer in introducing the concept of immunotherapy into dedicated clinical areas of high unmet medical need. The Company has a comprehensive and diverse IO portfolio and pipeline anchored in immunotherapies designed to overcome evasion of the anti-tumor immune response and stimulate the body’s immune system to attack tumors.

AstraZeneca strives to redefine cancer care and help transform outcomes for patients with IMFINZI as a monotherapy and in combination with IMJUDO as well as other novel immunotherapies and modalities. The Company is also investigating next-generation immunotherapies like bispecific antibodies and therapeutics that harness different aspects of immunity to target cancer, including cell therapy and T-cell engagers.

AstraZeneca is pursuing an innovative clinical strategy to bring IO-based therapies that deliver long-term survival to new settings across a wide range of cancer types. The Company is focused on exploring novel combination approaches to help prevent treatment resistance and drive longer immune responses. With an extensive clinical program, the Company also champions the use of IO treatment in earlier disease stages, where there is the greatest potential for cure.

AstraZeneca in oncology

AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

AstraZeneca

AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca-us.com and follow the Company on social media @AstraZeneca.

References

Sands J, et al. Tarlatamab plus durvalumab (durva) vs durva as 1L maintenance (1LM) therapy following durva, platinum, and etoposide (1L durva + EP) in extensive-stage small cell lung cancer (ES-SCLC): Primary analysis of the phase 3 DeLLphi-305 trial. Presented at the European Society for Medical Oncology Congress 2026, 24 October at 17:18 CEST.

World Health Organization. International Agency for Research on Cancer. Lung Fact Sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf. Accessed October 2026.

World Health Organization. International Agency for Research on Cancer. World Fact Sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/populations/900-world-fact-sheet.pdf. Accessed October 2026.

LUNGevity Foundation. Types of Lung Cancer. Available at: https://www.lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer. Accessed October 2026.

Shalata W, et al. Current and Emerging Therapeutic Strategies for Limited- and Extensive-Stage Small-Cell Lung Cancer. Med Sci (Basel). 2025;13(3):142.

AstraZeneca PLC. Investor relations epidemiology spreadsheet. Top 8 Countries. Available at: https://www.astrazeneca.com/investor-relations.html. Accessed October 2026.

Cao W, et al. Incidence, Risk Factors, and Impact of Immunotherapy on Brain Metastasis in Extensive-Stage Small Cell Lung Cancer Without Baseline Brain Involvement. JCO Oncol Pract. Published online 12 May 2026.

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Posted on October 24, 2026 10:33 am
Perioperative IMFINZI® (durvalumab) plus neoadjuvant enfortumab vedotin reduced risk of recurrence by 49% and risk of death by 42% in muscle-invasive bladder cancer

Perioperative IMFINZI® (durvalumab) plus neoadjuvant enfortumab vedotin reduced risk of recurrence by 49% and risk of death by 42% in muscle-invasive bladder cancer

More than three quarters of patients were still alive two years after treatment with perioperative IMFINZI plus three cycles of EV given before surgery

Data demonstrated statistically significant and clinically meaningful survival benefit and manageable safety profile

WILMINGTON, Del.–(BUSINESS WIRE)–
Positive results from the VOLGA Phase III trial showed perioperative treatment with AstraZeneca’s IMFINZI^® (durvalumab) in combination with neoadjuvant enfortumab vedotin (EV) demonstrated statistically significant and clinically meaningful improvements in the primary endpoint of event-free survival (EFS) and key secondary endpoint of overall survival (OS) in patients with muscle-invasive bladder cancer (MIBC) versus standard of care. Patients were ineligible for or had refused cisplatin-based chemotherapy. Patients in the comparator arm had a radical cystectomy (surgery to remove the bladder) with or without approved adjuvant treatment.

These results will be presented today in a Proffered Paper session during Presidential Symposium I at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain (abstract #LBA2).¹ They were also simultaneously published in TheNew England Journal of Medicine.

In a planned interim analysis, perioperative IMFINZI plus neoadjuvant EV demonstrated a 49% reduction in the risk of disease progression, recurrence, not undergoing surgery or death versus the comparator arm (based on an EFS hazard ratio [HR] of 0.51; 95% confidence interval [CI] 0.38-0.67; p<0.0001). Estimated median EFS was not yet reached for the IMFINZIcombination versus 12.1 months for the comparator arm. An estimated 64% of patients treated with the IMFINZI combination remained alive and event-free at two years compared to 45% in the comparator arm.

Results from the key secondary endpoint of OS showed that the IMFINZI combination reduced the risk of death by 42% compared to the comparator arm (based on an OS HR of 0.58; 95% CI 0.40-0.83; p=0.0027). Estimated median OS was not yet reached for the IMFINZI combination or comparator arm. An estimated 78% of patients treated with the IMFINZI combination were alive at two years compared to 69% in the comparator arm.

Thomas Powles, MD, Professor, Chair of Barts Cancer Centre, Barts Health NHS Trust, London, UK, and international coordinating investigator for the VOLGA trial, said: “Patients with muscle-invasive bladder cancer require life-changing bladder removal surgery. Despite this, the cancer returns in about half of patients. A new regimen of perioperative durvalumab combined with enfortumab vedotin before surgery reduced the risk of death by 42%, with a manageable safety profile. These practice-changing results support this approach as a patient centric, potential new standard of care in this setting.”

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “The VOLGA data show that more than three quarters of patients were still alive two years after treatment with the novel regimen of perioperative IMFINZI and neoadjuvant enfortumab vedotin, with quality of life maintained, allowing physicians to optimize treatment for patients in this curative-intent setting. These compelling results reinforce the potential for IMFINZI to become the immunotherapy backbone treatment across muscle-invasive and non-muscle-invasive bladder cancer.”

Summary of results: VOLGAⁱ

Perioperative IMFINZI

plus neoadjuvant EV

(n=233)

RCⁱⁱ with/without approved

adjuvant treatment

(n=229)

EFS

Number of patients with event, n (%)

84 (36)

123 (54)

Median EFS (95% CI) (in months)ⁱⁱⁱ

NR^iv

(33.2-NC^v)

12.1

(7.6-27.0)

HR (95% CI)

0.51

(0.38-0.67)

Stratified log-rank p-value^vi

<0.0001

EFS rate at 12 months (%)ⁱⁱⁱ

73

50

EFS rate at 24 months (%)ⁱⁱⁱ

64

45

OS

Number of deaths, n (%)

49 (21)

74 (32)

Median OS (95% CI) (in months)ⁱⁱⁱ

NR

(NC-NC)

NR

(37.7-NC)

HR (95% CI)

0.58

(0.40-0.83)

Stratified log-rank p-value^vii

0.0027

OS rate at 12 months (%)ⁱⁱⁱ

87

81

OS rate at 24 months (%)ⁱⁱⁱ

78

69

Data cut-off date was March 2, 2026

Radical cystectomy

Calculated by Kaplan-Meier method

Not reached

Not calculable

The threshold to declare statistical significance was based on a Lan-DeMets alpha spending function with O’Brien-Fleming boundary – with the observed number of events, the boundary for declaring statistical significance was 0.0218 for a 2.7% overall 2-sided alpha

The threshold to declare statistical significance was based on a Gamma family (-3) spending function – with the observed number of events, the boundary for declaring statistical significance was 0.0104 for a 5% overall 2-sided alpha

The safety and tolerability of the IMFINZI combination was consistent with the known safety profiles of the individual medicines with no new safety signals identified. Grade 3 and 4 adverse events due to any cause occurred in 64% of patients treated with the IMFINZI combination and 44% of patients in the comparator arm. Patient-reported quality of life was maintained after surgery in patients treated with the IMFINZI combination.

In September 2026, the Food and Drug Administration granted perioperative IMFINZI plus neoadjuvant EV Priority Review for the treatment of patients with MIBC who are ineligible for or have refused cisplatin-based chemotherapy based on these findings. Perioperative IMFINZI in combination with neoadjuvant chemotherapy is approved in over 50 countries for patients with cisplatin-eligible MIBC based on the NIAGARA Phase III trial.

IMPORTANT SAFETY INFORMATION

There are no contraindications for IMFINZI^® (durvalumab) or IMJUDO^® (tremelimumab-actl).

Severe and Fatal Immune-Mediated Adverse Reactions

Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue IMFINZI and IMJUDO depending on severity. See USPI Dosing and Administration for specific details. In general, if IMFINZI and IMJUDO requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.

Immune-Mediated Pneumonitis

IMFINZI and IMJUDO can cause immune-mediated pneumonitis, which may be fatal. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation.

IMFINZI as a Single Agent

In patients who did not receive recent prior radiation, the incidence of immune-mediated pneumonitis was 2.4% (34/1414), including fatal (<0.1%), and Grade 3-4 (0.4%) adverse reactions.

In patients who received recent prior radiation, the incidence of pneumonitis (including radiation pneumonitis) in patients with unresectable Stage III NSCLC following definitive chemoradiation within 42 days prior to initiation of IMFINZI in PACIFIC was 18.3% (87/475) in patients receiving IMFINZI and 12.8% (30/234) in patients receiving placebo. Of the patients who received IMFINZI (475), 1.1% were fatal and 2.7% were Grade 3 adverse reactions.

The incidence of pneumonitis (including radiation pneumonitis) in patients with LS-SCLC following chemoradiation within 42 days prior to initiation of IMFINZI in ADRIATIC was 14% (37/262) in patients receiving IMFINZI and 6% (16/265) in patients receiving placebo. Of the patients who received IMFINZI (262), 0.4% had a fatal adverse reaction and 2.7% had Grade 3 adverse reactions.

The frequency and severity of immune-mediated pneumonitis in patients who did not receive definitive chemoradiation prior to IMFINZI were similar in patients who received IMFINZI as a single agent or with ES-SCLC or BTC when given in combination with chemotherapy.

IMFINZI with IMJUDO

Immune‑mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions.

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

Immune-mediated pneumonitis occurred in 3.5% (21/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.5%), and Grade 3 (1%) adverse reactions.

Immune-Mediated Colitis

IMFINZI with IMJUDO and platinum-based chemotherapy can cause immune-mediated colitis, which may be fatal. IMFINZI and IMJUDO can cause immune-mediated colitis that is frequently associated with diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies.

IMFINZI as a Single Agent

Immune-mediated colitis occurred in 2% (37/1889) of patients receiving IMFINZI, including Grade 4 (<0.1%) and Grade 3 (0.4%) adverse reactions.

IMFINZI with IMJUDO

Immune‑mediated colitis or diarrhea occurred in 6% (23/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (3.6%) adverse reactions. Intestinal perforation has been observed in other studies of IMFINZI and IMJUDO.

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

Immune-mediated colitis occurred in 6.5% (39/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including fatal (0.2%) and Grade 3 (2.5%) adverse reactions. Intestinal perforation and large intestine perforation were reported in 0.1% of patients.

Immune-Mediated Hepatitis

IMFINZI and IMJUDO can cause immune-mediated hepatitis, which may be fatal.

IMFINZI as a Single Agent

Immune-mediated hepatitis occurred in 2.8% (52/1889) of patients receiving IMFINZI, including fatal (0.2%), Grade 4 (0.3%) and Grade 3 (1.4%) adverse reactions.

IMFINZI with IMJUDO

Immune‑mediated hepatitis occurred in 7.5% (29/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.8%), Grade 4 (0.3%) and Grade 3 (4.1%) adverse reactions.

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

Immune-mediated hepatitis occurred in 3.9% (23/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.3%), Grade 4 (0.5%), and Grade 3 (2%) adverse reactions.

Immune-Mediated Endocrinopathies

Adrenal Insufficiency:IMFINZI and IMJUDO can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated.

IMFINZI as a Single Agent

Immune-mediated adrenal insufficiency occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.

IMFINZI with IMJUDO

Immune-mediated adrenal insufficiency occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

Immune-mediated adrenal insufficiency occurred in 2.2% (13/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.8%) adverse reactions.

Hypophysitis:IMFINZI and IMJUDO can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate symptomatic treatment including hormone replacement as clinically indicated.

IMFINZI as a Single Agent

Grade 3 hypophysitis/hypopituitarism occurred in <0.1% (1/1889) of patients who received IMFINZI.

IMFINZI with IMJUDO

Immune-mediated hypophysitis/hypopituitarism occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO.

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

Immune-mediated hypophysitis occurred in 1.3% (8/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions.

Thyroid Disorders:IMFINZI and IMJUDO can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement therapy for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated.

IMFINZI as a Single Agent

Immune-mediated thyroiditis occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.

Immune-mediated hyperthyroidism occurred in 2.1% (39/1889) of patients receiving IMFINZI.

Immune-mediated hypothyroidism occurred in 8.3% (156/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.

IMFINZI with IMJUDO

Immune-mediated thyroiditis occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO.

Immune-mediated hyperthyroidism occurred in 4.6% (18/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.

Immune-mediated hypothyroidism occurred in 11% (42/388) of patients receiving IMFINZI and IMJUDO.

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

Immune-mediated thyroiditis occurred in 1.2% (7/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy.

Immune-mediated hyperthyroidism occurred in 5% (30/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions.

Immune-mediated hypothyroidism occurred in 8.6% (51/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions.

IMFINZI with Carboplatin and Paclitaxel

Immune-mediated hypothyroidism occurred in 14% (34/235) of patients receiving IMFINZI in combination with carboplatin and paclitaxel.

Type 1 Diabetes Mellitus, which can present with diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated.

IMFINZI as a Single Agent

Grade 3 immune-mediated Type 1 diabetes mellitus occurred in <0.1% (1/1889) of patients receiving IMFINZI.

IMFINZI with IMJUDO

Two patients (0.5%, 2/388) had events of hyperglycemia requiring insulin therapy that had not resolved at last follow-up.

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

Immune-mediated Type 1 diabetes mellitus occurred in 0.5% (3/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including Grade 3 (0.3%) adverse reactions.

Immune-Mediated Nephritis with Renal Dysfunction

IMFINZI and IMJUDO can cause immune-mediated nephritis.

IMFINZI as a Single Agent

Immune-mediated nephritis occurred in 0.5% (10/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.

IMFINZI with IMJUDO

Immune-mediated nephritis occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.5%) adverse reactions.

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

Immune-mediated nephritis occurred in 0.7% (4/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions.

Immune-Mediated Dermatology Reactions

IMFINZI and IMJUDO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson Syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), has occurred with PD-1/L-1 and CTLA-4 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes.

IMFINZI as a Single Agent

Immune-mediated rash or dermatitis occurred in 1.8% (34/1889) of patients receiving IMFINZI, including Grade 3 (0.4%) adverse reactions.

IMFINZI with IMJUDO

Immune-mediated rash or dermatitis occurred in 4.9% (19/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions.

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

Immune-mediated rash or dermatitis occurred in 7.2% (43/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.3%) adverse reactions.

Immune-Mediated Pancreatitis

IMFINZI in combination with IMJUDO can cause immune-mediated pancreatitis. Immune-mediated pancreatitis occurred in 2.3% (9/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions.

Other Immune-Mediated Adverse Reactions

The following clinically significant, immune-mediated adverse reactions occurred at an incidence of less than 1% each in patients who received IMFINZI and IMJUDO or were reported with the use of other immune-checkpoint inhibitors.

Cardiac/vascular: Myocarditis, pericarditis, vasculitis.

Nervous system: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy.

Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss.

Gastrointestinal: Pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis.

Musculoskeletal and connective tissue disorders: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatica.

Endocrine: Hypoparathyroidism.

Hematologic/Immune: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection, other transplant (including corneal graft) rejection.

Other: Myocarditis-Myositis-Myasthenia Gravis (or Myasthenia-Like) Overlap Syndrome, reported as the co-occurrence of either two or all three adverse reactions

Infusion-Related Reactions

IMFINZI and IMJUDO can cause severe or life-threatening infusion-related reactions. Monitor for signs and symptoms of infusion-related reactions. Interrupt, slow the rate of, or permanently discontinue IMFINZI and IMJUDO based on the severity. See USPI Dosing and Administration for specific details. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses.

IMFINZI as a Single Agent

Infusion-related reactions occurred in 2.2% (42/1889) of patients receiving IMFINZI, including Grade 3 (0.3%) adverse reactions.

IMFINZI with IMJUDO

Infusion-related reactions occurred in 2.6% (10/388) of patients receiving IMFINZI and IMJUDO.

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

Infusion-related reactions occurred in 2.9% (17/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.3%) adverse reactions.

Complications of Allogeneic HSCT after IMFINZI

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/L-1 blocking antibody. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/L-1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an allogeneic HSCT.

Embryo-Fetal Toxicity

Based on their mechanism of action and data from animal studies, IMFINZI and IMJUDO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. In females of reproductive potential, verify pregnancy status prior to initiating IMFINZI and IMJUDO and advise them to use effective contraception during treatment with IMFINZI and IMJUDO and for 3 months after the last dose of IMFINZI and IMJUDO.

Lactation

There is no information regarding the presence of IMFINZI and IMJUDO in human milk; however, because of the potential for serious adverse reactions in breastfed infants from IMFINZI and IMJUDO, advise women not to breastfeed during treatment and for 3 months after the last dose.

Adverse Reactions

Unresectable Stage III NSCLC

In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), the most common adverse reactions (≥20%) were cough (40%), fatigue (34%), pneumonitis or radiation pneumonitis (34%), upper respiratory tract infections (26%), dyspnea (25%), and rash (23%). The most common Grade 3 or 4 adverse reactions (≥3%) were pneumonia (7%) and pneumonitis/radiation pneumonitis (3.4%).

In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), discontinuation due to adverse reactions occurred in 15% of patients in the IMFINZI arm. Serious adverse reactions occurred in 29% of patients receiving IMFINZI. The most frequent serious adverse reactions (≥2%) were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%). Fatal pneumonitis or radiation pneumonitis and fatal pneumonia occurred in <2% of patients and were similar across arms.

Resectable NSCLC

In patients with resectable NSCLC in the AEGEAN study, the most common adverse reactions (occurring in ≥20% of patients) were anemia, nausea, constipation, fatigue, musculoskeletal pain, and rash.

In patients with resectable NSCLC in the neoadjuvant phase of the AEGEAN study receiving IMFINZI in combination with platinum-containing chemotherapy (n=401), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 6.7% of patients. Serious adverse reactions occurred in 21% of patients. The most frequent (≥1%) serious adverse reactions were pneumonia (2.7%), anemia (1.5%), myelosuppression (1.5%), vomiting (1.2%), neutropenia (1%), and acute kidney injury (1%). Fatal adverse reactions occurred in 2% of patients, including death due to COVID-19 pneumonia (0.5%), sepsis (0.5%), myocarditis (0.2%), decreased appetite (0.2%), hemoptysis (0.2%), and death not otherwise specified (0.2%). Of the 401 IMFINZI-treated patients who received neoadjuvant treatment and 398 placebo-treated patients who received neoadjuvant treatment, 1.7% (n=7) and 1% (n=4), respectively, did not receive surgery due to adverse reactions.

In patients with resectable NSCLC in the adjuvant phase of the AEGEAN study receiving IMFINZI as a single agent (n=265), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 8% of patients. Serious adverse reactions occurred in 13% of patients. The most frequent serious adverse reactions reported in >1% of patients were pneumonia (1.9%), pneumonitis (1.1%), and COVID-19 (1.1%). Four fatal adverse reactions occurred during the adjuvant phase of the study, including COVID-19 pneumonia, pneumonia aspiration, interstitial lung disease and aortic aneurysm.

Metastatic NSCLC

In patients with mNSCLC in the POSEIDON study receiving IMFINZI and IMJUDO plus platinum-based chemotherapy (n=330), the most common adverse reactions (occurring in ≥20% of patients) were nausea (42%), fatigue (36%), musculoskeletal pain (29%), decreased appetite (28%), rash (27%), and diarrhea (22%).

In patients with mNSCLC in the POSEIDON study receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy (n=330), permanent discontinuation of IMFINZI or IMJUDO due to an adverse reaction occurred in 17% of patients. Serious adverse reactions occurred in 44% of patients, with the most frequent serious adverse reactions reported in at least 2% of patients being pneumonia (11%), anemia (5%), diarrhea (2.4%), thrombocytopenia (2.4%), pyrexia (2.4%), and febrile neutropenia (2.1%). Fatal adverse reactions occurred in a total of 4.2% of patients.

Limited-stage Small Cell Lung Cancer

In patients with limited-stage SCLC in the ADRIATIC study receiving IMFINZI (n=262), the most common adverse reactions occurring in ≥20% of patients receiving IMFINZI were pneumonitis or radiation pneumonitis (38%), and fatigue (21%). The most common Grade 3 or 4 adverse reactions (≥3%) were pneumonitis or radiation pneumonitis and pneumonia.

In patients with limited-stage SCLC in the ADRIATIC study receiving IMFINZI (n=262), IMFINZI was permanently discontinued due to adverse reactions in 16% of the patients receiving IMFINZI. Serious adverse reactions occurred in 30% of patients receiving IMFINZI. The most frequent serious adverse reactions reported in ≥1% of patients receiving IMFINZI were pneumonitis or radiation pneumonitis (12%), and pneumonia (5%). Fatal adverse reactions occurred in 2.7% of patients who received IMFINZI including pneumonia (1.5%), cardiac failure, encephalopathy and pneumonitis (0.4% each).

Extensive-stage Small Cell Lung Cancer

In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), the most common adverse reactions (≥20%) were nausea (34%), fatigue/asthenia (32%), and alopecia (31%). The most common Grade 3 or 4 adverse reaction (≥3%) was fatigue/asthenia (3.4%).

In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), IMFINZI was discontinued due to adverse reactions in 7% of the patients receiving IMFINZI plus chemotherapy. Serious adverse reactions occurred in 31% of patients receiving IMFINZI plus chemotherapy. The most frequent serious adverse reactions reported in at least 1% of patients were febrile neutropenia (4.5%), pneumonia (2.3%), anemia (1.9%), pancytopenia (1.5%), pneumonitis (1.1%), and COPD (1.1%). Fatal adverse reactions occurred in 4.9% of patients receiving IMFINZI plus chemotherapy.

Locally Advanced or Metastatic Biliary Tract Cancers (BTCs)

In patients with locally advanced or metastatic BTCs in the TOPAZ-1 study receiving IMFINZI (n=338), the most common adverse reactions (occurring in ≥20% of patients) were fatigue (42%), nausea (40%), constipation (32%), decreased appetite (26%), abdominal pain (24%), rash (23%), and pyrexia (20%).

In patients with locally advanced or metastatic BTCs in the TOPAZ-1 study receiving IMFINZI (n=338), discontinuation due to adverse reactions occurred in 6% of the patients receiving IMFINZI plus chemotherapy. Serious adverse reactions occurred in 47% of patients receiving IMFINZI plus chemotherapy. The most frequent serious adverse reactions reported in at least 2% of patients were cholangitis (7%), pyrexia (3.8%), anemia (3.6%), sepsis (3.3%), and acute kidney injury (2.4%). Fatal adverse reactions occurred in 3.6% of patients receiving IMFINZI plus chemotherapy. These include ischemic or hemorrhagic stroke (4 patients), sepsis (2 patients), and upper gastrointestinal hemorrhage (2 patients).

Unresectable Hepatocellular Carcinoma (HCC)

In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and IMJUDO (n=388), the most common adverse reactions (occurring in ≥20% of patients) were rash (32%), diarrhea (27%), fatigue (26%), pruritus (23%), musculoskeletal pain (22%), and abdominal pain (20%).

In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and IMJUDO (n=388), serious adverse reactions occurred in 41% of patients. Serious adverse reactions in >1% of patients included hemorrhage (6%), diarrhea (4%), sepsis (2.1%), pneumonia (2.1%), rash (1.5%), vomiting (1.3%), acute kidney injury (1.3%), and anemia (1.3%). Fatal adverse reactions occurred in 8% of patients who received IMFINZI and IMJUDO, including death (1%), hemorrhage intracranial (0.5%), cardiac arrest (0.5%), pneumonitis (0.5%), hepatic failure (0.5%), and immune-mediated hepatitis (0.5%). Permanent discontinuation of treatment regimen due to an adverse reaction occurred in 14% of patients.

Primary Advanced or Recurrent dMMR Endometrial Cancer

In patients with primary advanced or recurrent dMMR endometrial cancer in the DUO-E study receiving IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent (n=44), the most common adverse reactions, including laboratory abnormalities (occurring in >20% of patients) were peripheral neuropathy (61%), musculoskeletal pain (59%), nausea (59%), alopecia (52%), fatigue (41%), abdominal pain (39%), constipation (39%), rash (39%), decreased magnesium (36%), increased ALT (32%), increased AST (30%), diarrhea (27%), vomiting (27%), cough (27%), decreased potassium (25%), dyspnea (25%), headache (23%), increased alkaline phosphatase (20%), and decreased appetite (18%). The most common Grade 3 or 4 adverse reactions (≥3%) were constipation (4.5%) and fatigue (4.5%).

In patients with primary advanced or recurrent dMMR endometrial cancer in the DUO-E study receiving IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent (n=44), permanent discontinuation of IMFINZI due to adverse reactions occurred in 11% of patients. Serious adverse reactions occurred in 30% of patients who received IMFINZI with carboplatin and paclitaxel; the most common serious adverse reactions (≥4%) were constipation (4.5%) and rash (4.5%).

BCG-Naive, High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC)

In patients with BCG-naive, HR-NMIBC in the POTOMAC study receiving IMFINZI in combination with BCG, the most common (≥20%) adverse reactions, including laboratory abnormalities were increased glucose (43%), increased AST (43%), increased lipase (42%), increased ALT (42%), increased GGT (40%), urinary tract infection (40%), increased potassium (39%), dysuria (37%), decreased hemoglobin (35%), hematuria (33%), increased serum creatinine (30%), musculoskeletal pain (28%), decreased lymphocytes (27%), urinary frequency (26%), decreased sodium (23%), fatigue (21%), rash (20%), and pyrexia (20%).

In patients with BCG-naive, HR-NMIBC in the POTOMAC study receiving IMFINZI in combination with BCG, permanent discontinuation of IMFINZI due to adverse reactions occurred in 18% of patients. The adverse reactions which resulted in permanent discontinuation of IMFINZI (≥1%) were hepatitis (1.8%), acute kidney injury (1.2%), and diarrhea (1.2%). Serious adverse reactions occurred in 32% of patients. The most common (≥1%) serious adverse reactions were urinary tract infection (4.5%), COVID (1.8%), hepatitis (1.5%), dysuria (1.2%), and prostate cancer (1.2%). Fatal adverse reactions occurred in 2.4% of patients who received IMFINZI in combination with BCG, including congestive cardiac failure (0.6%), COVID (0.3%), cardiovascular disorder (0.3%), dementia with Lewy bodies (0.3%), and pancreatic cancer (0.3%).

Muscle-Invasive Bladder Cancer (MIBC)

In patients with MIBC, the most common adverse reactions, including laboratory abnormalities, in the overall study (occurring in ≥20% of patients) were decreased hemoglobin, decreased neutrophils, increased blood creatinine, decreased sodium, nausea, increased ALT, decreased calcium, decreased platelets, fatigue, increased potassium, decreased lymphocytes, increased AST, constipation, decreased magnesium, decreased appetite, increased alkaline phosphatase, rash, pyrexia, diarrhea, vomiting and abdominal pain.

In patients with MIBC in the neoadjuvant phase of the NIAGARA study receiving IMFINZI in combination with gemcitabine and cisplatin (n=530), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 9% of patients. Serious adverse reactions occurred in 24% of patients; the most frequent (≥1%) serious adverse reactions were pulmonary embolism (1.9%), febrile neutropenia (1.5%), acute kidney injury (1.3%), thrombocytopenia (1.3%), urinary tract infection (1.3%), and pneumonia (1.3%). Fatal adverse reactions occurred in 1.1% of patients including sepsis, myocardial infarction, and pulmonary embolism (0.2% each). One fatal adverse reaction of pneumonia was reported in 1 (0.2%) patient in the post-surgery phase before adjuvant treatment started. Of the 530 patients in the IMFINZI treatment arm and 526 patients in the chemotherapy treatment arm who received neoadjuvant treatment, 1 (0.2%) patient in each treatment arm did not receive surgery due to adverse reactions. The adverse reaction that led to cancellation of surgery in the IMFINZI treatment arm was interstitial lung disease.

In patients with MIBC in the adjuvant phase of the NIAGARA study receiving IMFINZI as a single agent (n=383), permanent discontinuation of adjuvant IMFINZI due to an adverse reaction occurred in 5% of patients. Serious adverse reactions occurred in 26% of patients. The most frequent serious adverse reactions (occurring in ≥1% of patients) were urinary tract infection (7%), acute kidney injury (3.7%), hydronephrosis (2.1%), pyelonephritis (2.1%), urosepsis (1.8%) and sepsis (1.6%). Fatal adverse reactions occurred in 1.8% of patients, including COVID-19, severe acute respiratory syndrome, cardiopulmonary failure, gastrointestinal hemorrhage, and chronic hepatic failure (0.3% each).

Resectable Gastric Cancer/Gastroesophageal Junction Adenocarcinoma (GC/GEJC)

In patients with resectable GC/GEJC, the most common adverse reactions in the overall study (occurring in ≥20% of patients) were diarrhea, nausea, peripheral neuropathy, fatigue, alopecia, decreased appetite, rash, abdominal pain, vomiting, musculoskeletal pain, pyrexia, and stomatitis.

In patients with resectable GC/GEJC in the neoadjuvant phase of the MATTERHORN study receiving IMFINZI in combination with FLOT chemotherapy (n=475), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 2.5% of patients. Serious adverse reactions occurred in 21% of patients; the most frequent (≥2%) serious adverse reaction was diarrhea (2.5%). Deaths occurred in 1.9% of patients; deaths of ≥2 patients included septic shock (0.6%) and acute coronary syndrome (0.4%). Of the 475 patients in the IMFINZI + FLOT chemotherapy treatment arm and 469 patients in the placebo + FLOT chemotherapy treatment arm who received neoadjuvant treatment, 0.6% and 0.4% of patients, respectively, did not receive surgery due to adverse reactions, and 2.3% and 2.6% of patients, respectively, had a delay in surgery due to ARs.

In patients with resectable GC/GEJC in the adjuvant phase of the MATTERHORN study receiving IMFINZI in combination with FLOT chemotherapy (n=365), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 7% of patients. Serious adverse reactions occurred in 29% of patients; the most frequent (≥2%) serious adverse reaction was pneumonia (2.5%). Deaths occurred in 2.2% of patients; deaths of ≥2 patients included gastrointestinal perforation (0.5%) and COVID-19 (0.5%).

In patients with resectable GC/GEJC in the adjuvant phase of the MATTERHORN study receiving IMFINZI alone (n=345), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 6% of patients. Serious adverse reactions occurred in 14% of patients. Deaths occurred in 1.7% of patients; deaths of ≥2 patients included gastrointestinal perforation (0.6%) and COVID-19 (0.6%).

The safety and effectiveness of IMFINZI and IMJUDO have not been established in pediatric patients.

Indications:

IMFINZI, as a single agent, is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).

IMFINZI in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, is indicated for the treatment of adult patients with resectable (tumors ≥4 cm and/or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.

IMFINZI, in combination with IMJUDO and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations.

IMFINZI, as a single agent, is indicated for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).

IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

IMFINZI, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC).

IMFINZI in combination with IMJUDO is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).

IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) as determined by an FDA-authorized test.

IMFINZI in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-naive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC).

IMFINZI in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent IMFINZI as adjuvant treatment following radical cystectomy, is indicated for the treatment of adult patients with muscle-invasive bladder cancer (MIBC).

IMFINZI in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) as neoadjuvant and adjuvant treatment, followed by single agent IMFINZI, is indicated for the treatment of adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).

Please see Full Prescribing Information including Medication Guide for IMFINZI and IMJUDO.

Notes

Bladder cancer

Bladder cancer is the 8th most common cancer in the world, with more than 635,000 cases diagnosed each year.² The most common type is urothelial carcinoma, which begins in the urothelial cells of the urinary tract.³ Approximately one in four patients with bladder cancer has muscle-invasive disease, where the tumor invades the muscle wall of the bladder, without distant metastases.^4,5

In 2026, around 106,500 patients will be treated for MIBC.⁶ In 2025, the NIAGARA Phase III trial established a new standard of care by adding perioperative IMFINZI to neoadjuvant cisplatin-based chemotherapy and radical cystectomy.⁷ However, up to half of patients are not eligible to receive cisplatin due to impaired renal function or comorbidities.^8-10 The standard treatment for these patients has historically been radical cystectomy alone but, despite undergoing this major surgery, patients experience high rates of recurrence and have a poor prognosis.^8-10 New treatment options that prevent both progression before surgery and recurrence after surgery are critically needed in this curative-intent setting.

VOLGA

VOLGA is a Phase III, randomized, open-label, multi-center global trial evaluating perioperative IMFINZI with or without IMJUDO^® (tremelimumab-actl) in combination with neoadjuvant EV as treatment for patients with MIBC undergoing radical cystectomy who are ineligible for or have refused cisplatin compared to radical cystectomy with or without approved adjuvant therapy. In the trial, 695 patients were randomized 1:1:1 to Arm 1 (three cycles of IMFINZI and EV, plus two cycles of IMJUDO prior to surgery, followed by nine cycles of IMFINZI plus one cycle of IMJUDO as adjuvant therapy), Arm 2 (three cycles of IMFINZI and EV prior to surgery, followed by nine cycles of IMFINZI adjuvant monotherapy) and Arm 3, the comparator arm.

The trial was conducted in 182 centers across 25 countries in Europe, North America, South America and Asia. Its dual primary endpoints are EFS, defined as the time from randomization to first recurrence post-radical cystectomy, first progression in patients who did not undergo radical cystectomy, failure to undergo radical cystectomy in patients with residual disease or death due to any cause, for both experimental arms versus the comparator arm. Secondary endpoints include OS (Arm 1 vs. Arm 3 and Arm 2 vs. Arm 3), pathologic complete response, disease-free survival and pathologic downstaging across both experimental arms.

IMFINZI^® (durvalumab)

IMFINZI^® (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumor’s immune-evading tactics and releasing the inhibition of immune responses.

In addition to its indication in MIBC based on the NIAGARA data, IMFINZI in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy is approved in the US, Japan and other countries for patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer, based on the POTOMAC Phase III trial. In July 2026, positive high-level results from the NILE Phase III trial showed IMFINZI plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS versus chemotherapy as 1st-line treatment for patients with PD-L1 high unresectable, locally advanced or metastatic urothelial cancer.

In addition to its bladder cancer indications, IMFINZI is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy (CRT). Additionally, IMFINZI is approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable NSCLC, and in combination with a short course of IMJUDO^® (tremelimumab-actl) and chemotherapy for the treatment of metastatic NSCLC. IMFINZI is also approved for limited-stage small cell lung cancer (SCLC) and in combination with chemotherapy (etoposide and either carboplatin or cisplatin) for the treatment of extensive-stage SCLC.

IMFINZI is also approved in combination with chemotherapy in locally advanced or metastatic biliary tract cancer and in combination with IMJUDO in unresectable hepatocellular carcinoma (HCC). It is also approved as a monotherapy in unresectable HCC in Japan, China and the EU, and in resectable, early-stage and locally advanced gastric and gastroesophageal junction cancers in the US, EU and Japan. Additionally, in April 2026, IMFINZI in combination with IMJUDO, lenvatinib and transarterial chemoembolization (TACE) demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival versus TACE alone for patients with unresectable HCC eligible for embolization in the EMERALD-3 Phase III trial.

IMFINZI in combination with chemotherapy followed by IMFINZI monotherapy is approved as a 1st-line treatment for primary advanced or recurrent endometrial cancer (mismatch repair deficient disease only in the US, EU and China). IMFINZI in combination with chemotherapy followed by olaparib and IMFINZI is approved for patients with mismatch repair proficient advanced or recurrent endometrial cancer in the EU and Japan.

Since the first approval in May 2017, more than 470,000 patients have been treated with IMFINZI. As part of a broad development program, IMFINZI is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with NSCLC, bladder cancer, breast cancer, ovarian cancer and several gastrointestinal cancers.

AstraZeneca in immuno-oncology (IO)

AstraZeneca is a pioneer in introducing the concept of immunotherapy into dedicated clinical areas of high unmet medical need. The Company has a comprehensive and diverse IO portfolio and pipeline anchored in immunotherapies designed to overcome evasion of the anti-tumor immune response and stimulate the body’s immune system to attack tumors.

AstraZeneca strives to redefine cancer care and help transform outcomes for patients with IMFINZI as a monotherapy and in combination with IMJUDO as well as other novel immunotherapies and modalities. The Company is also investigating next-generation immunotherapies like bispecific antibodies and therapeutics that harness different aspects of immunity to target cancer, including cell therapy and T-cell engagers.

AstraZeneca is pursuing an innovative clinical strategy to bring IO-based therapies that deliver long-term survival to new settings across a wide range of cancer types. The Company is focused on exploring novel combination approaches to help prevent treatment resistance and drive longer immune responses. With an extensive clinical program, the Company also champions the use of IO treatment in earlier disease stages, where there is the greatest potential for cure.

AstraZeneca in oncology

AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

AstraZeneca

AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca-us.com and follow the Company on social media @AstraZeneca.

References

Powles T, et al. Perioperative durvalumab with or without tremelimumab plus neoadjuvant enfortumab vedotin in muscle-invasive bladder cancer: results from the Phase 3 VOLGA trial. Presented at the European Society for Medical Oncology Congress 2026, 24 October at 16:54 CEST.

World Health Organization. International Agency for Research on Cancer. Bladder Fact Sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/30-bladder-fact-sheet.pdf. Accessed October 2026.

American Cancer Society. What Is Bladder Cancer? Available at: https://www.cancer.org/cancer/types/bladder-cancer/about/what-is-bladder-cancer.html. Accessed October 2026.

Burger M, et al. Epidemiology and Risk Factors of Urothelial Bladder Cancer. Eur Urol. 2013;63(2):234-241.

National Collaborating Centre for Cancer. Bladder Cancer: Diagnosis and Management. London: National Institute for Health and Care Excellence (NICE). Available at: https://www.ncbi.nlm.nih.gov/books/NBK356289/. Accessed October 2026.

AstraZeneca PLC. Investor relations epidemiology spreadsheet. Available at: https://www.astrazeneca.com/investor-relations.html. Accessed October 2026.

AstraZeneca PLC. IMFINZI approved in the US as first and only perioperative immunotherapy for patients with muscle-invasive bladder cancer. Available at: https://www.astrazeneca.com/media-centre/press-releases/2025/imfinzi-approved-in-the-us-for-bladder-cancer.html. Accessed October 2026.

Dash A, et al. Impact of renal impairment on eligibility for adjuvant cisplatin-based chemotherapy in patients with urothelial carcinoma of the bladder. Cancer. 2006;107(3):506-513.

Holzbeierlein J, et al. Treatment of Non-Metastatic Muscle-Invasive Bladder Cancer: AUA/ASCO/SUO Guideline (2017; Amended 2020, 2024). J Urology. 2024;212(1):3-10.

Galsky MD, et al. Treatment of patients with metastatic urothelial cancer “unfit” for cisplatin-based chemotherapy. J Clin Oncol. 2011;29(17):2432-2438.

US-117641 Last Updated 10/26

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Posted on October 24, 2026 8:48 am
Parabilis Medicines Presents Updated Phase 1/2 Data for Zolucatetide Demonstrating Compelling Efficacy and Favorable Safety and Tolerability Profile in Patients with Desmoid Tumors

Objective response rate of 72.2% among response-evaluable patients receiving a starting dose of ≥450 mg at 32-week landmark

Disease control rate of 100% across all response-evaluable patients receiving a starting dose of ≥450 mg, with no disease progression and no treatment discontinuations due to TRAEs

Data informed FDA-aligned dose and regimen selection for upcoming PEDESTAL Phase 3 registrational trial, with initiation planned in the first half of 2027 and topline results anticipated in 2029

Company to host investor webcast on Saturday, October 24, 2026, at 18:00 CEST (12:00 p.m. EDT)

CAMBRIDGE, Mass., Oct. 24, 2026 (GLOBE NEWSWIRE) — Parabilis Medicines (Nasdaq: PBLS), a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for patients with serious diseases by unlocking historically undruggable targets, today announced updated safety and efficacy data for zolucatetide, the first and only direct inhibitor of the β-catenin:TCF interaction, in patients with desmoid tumors. The data were presented today in an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2026, taking place October 23–27, 2026, in Madrid, Spain.

The updated results, based on a June 22, 2026, data cutoff, include data from both the dose escalation and dose optimization portions of the ongoing Phase 1/2 trial and reinforce the strong efficacy and favorable safety and tolerability profile observed with zolucatetide. Among response-evaluable patients who began treatment at a starting dose of ≥450 mg, zolucatetide demonstrated an objective response rate (ORR) of 72.2% (13/18) in a 32-week landmark analysis. A disease control rate (DCR) of 100% was observed across all 46 response-evaluable patients who received a starting dose of ≥450 mg, with no disease progression.

Data from a three-arm randomized dose optimization trial supported selection of a 450 mg weekly induction regimen administered for four cycles, followed by 300 mg every two weeks for long-term maintenance. Following productive end-of-Phase 2 discussions, Parabilis has reached alignment with the U.S. Food and Drug Administration (FDA) on the selected dose and regimen, on the use of a placebo-controlled study design, and on progression-free survival (PFS) as the primary endpoint for registrational development.

Parabilis plans to initiate the randomized, double-blind PEDESTAL Phase 3 trial (Phase 3 Evaluation of DESmoid Tumor Activity with zoLucatetide) in the first half of 2027, with topline results anticipated in 2029.

“Desmoid tumors are chronic and life-altering for patients, often affecting people at a young age, and patients need treatments that can deliver rapid, deep and durable tumor responses with a tolerability profile suited for long-term treatment,” said Mathai Mammen, M.D., Ph.D., Chairman, CEO and President of Parabilis Medicines. “We designed zolucatetide to directly inhibit β-catenin:TCF, a historically undruggable target at the heart of the biology driving these tumors. The depth and consistency of responses we are seeing, together with the favorable safety and tolerability profile observed to date, reinforce our conviction that zolucatetide has the potential to deliver a truly differentiated medicine and meaningfully expand the number of patients who can benefit from treatment. We are very pleased with the clarity of the FDA’s feedback on our registrational development strategy, and with our Phase 3 regimen selected, we are moving with urgency to bring this medicine to patients.”

Updated Phase 1/2 Results
As of the June 22, 2026, data cutoff, 76 patients with desmoid tumors had been enrolled and treated across all dose levels in the dose escalation and dose optimization portions of the trial. Median age was 37 years (range 19–80), and 69.7% of patients were female. The population included both patients who had previously been treated with and failed gamma-secretase inhibitors (GSIs) and patients naive to GSIs.

A total of 48 patients began treatment at a starting induction dose of ≥450 mg, prior to down-dosing for maintenance. Two patients were started at 900 mg, but had an average dose of 400–500 mg over the first four months of treatment. Of these 48 patients, 46 were response-evaluable, and 18 had scans at 32 weeks. Median time on treatment for this cohort was 4.7 months (range 0.5–22.3), reflecting recent enrollment of a substantial portion of the cohort.

Efficacy

ORR per RECIST 1.1 was 72.2% (13/18) among all patients evaluable at the 32-week landmark

A disease control rate (DCR) of 100% was observed across all 46 response-evaluable patients

Responses were observed irrespective of prior gamma-secretase inhibitor (GSI) exposure or CTNNB1 or APC mutation status

No evidence of disease progression or resistance

Safety

Zolucatetide continued to demonstrate a favorable safety and tolerability profile at the selected doses for Phase 3 registrational development

Treatment-related adverse events (TRAEs) were predominantly low-grade; the most commonly reported TRAEs were fatigue, alopecia and nausea

No patients discontinued treatment due to TRAEs

Not associated with ovarian toxicity or high-grade gastrointestinal or skin toxicities commonly reported with GSIs

“The early clinical results with zolucatetide are encouraging, particularly the magnitude and apparent rapidity of tumor responses observed to date,” said Mrinal Gounder, M.D., Sarcoma Medical Oncologist and Early Drug Development Specialist at Memorial Sloan Kettering Cancer Center, and presenting author of the study. “Desmoid tumors can impose a substantial physical and emotional burden on patients, and therapies capable of achieving meaningful tumor shrinkage while maintaining acceptable tolerability remain an important clinical goal. These findings support further investigation of zolucatetide in the planned Phase 3 trial.”

The Phase 1/2 trial is ongoing in patients with desmoid tumors and a range of other tumor types driven by alterations in the Wnt/β-catenin pathway, and follow-up is continuing. Zolucatetide has received Fast Track and Orphan Drug Designations from the FDA for the treatment of desmoid tumors.

These findings provide further clinical validation of the potential of the Company’s Helicon™ platform to unlock disease-driving targets historically considered undruggable.

Investor Webcast
Parabilis will host an investor webcast on Saturday, October 24, 2026, at 18:00 CEST (12:00 p.m. EDT) to discuss the updated zolucatetide data that will be presented at ESMO Congress 2026. The webcast will be available on the Investors section of the Parabilis website at https://investors.parabilismed.com. Both the presentation and a replay of the webcast will be available following the event.

About Desmoid Tumors

Desmoid tumors are locally invasive soft-tissue tumors that arise in connective tissues and can be aggressive and recurrent, often causing chronic pain, limited mobility, disfigurement and organ dysfunction. An estimated 30,000 people in the U.S. alone are living with desmoid tumors, including approximately 11,000 who are actively managed, with significant unmet need globally as well. Desmoid tumors typically present in young adults, predominantly females, with many patients requiring prolonged or intermittent treatment. Wnt/β-catenin pathway-activating mutations are the causal driver of desmoid tumors, yet no approved therapies directly target this underlying biology of the disease.

About Zolucatetide
Zolucatetide is an investigational first-in-class and first and only direct inhibitor of the interaction between β-catenin and the T-cell factor (TCF) family of transcription factors, a genetically validated driver of numerous cancers and other serious diseases that has long been considered undruggable. Developed using Parabilis’ Helicon™ peptide platform, zolucatetide is designed to prevent the activation of disease-driving genes by directly targeting β-catenin:TCF, a key downstream node in the Wnt/β-catenin pathway. This approach has the potential to address aberrant Wnt/β-catenin signaling regardless of the upstream APC or β-catenin mutations driving pathway activation, potentially overcoming a key limitation of approaches targeting earlier steps in the pathway.

Zolucatetide is currently being evaluated in an ongoing Phase 1/2 clinical trial (NCT05919264) across a range of indications, including desmoid tumors, familial adenomatous polyposis (FAP), adamantinomatous craniopharyngioma (ACP), hepatocellular carcinoma (HCC) and additional Wnt-driven tumor types.

About Parabilis Medicines
Parabilis Medicines (Nasdaq: PBLS) is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for patients with serious diseases by unlocking biologically important targets long considered undruggable. The Company has pioneered a new class of alpha-helical peptides – Helicons™ – capable of modulating intracellular proteins that have historically been beyond the reach of conventional medicines. The Company’s lead investigational medicine, zolucatetide, is the first and only direct inhibitor of the β-catenin:TCF interaction, a central node in the Wnt/β-catenin pathway that has eluded drug developers for decades. Zolucatetide is being evaluated in the clinic across multiple Wnt/β-catenin-driven diseases, including desmoid tumors, familial adenomatous polyposis (FAP), adamantinomatous craniopharyngioma (ACP), hepatocellular carcinoma (HCC) and a range of other rare and common solid tumor indications. Beyond zolucatetide, Parabilis is pursuing a follow-on β-catenin degrader program and advancing additional Helicon-based programs focused on other challenging targets, including ERG and allosteric AR^ON in prostate cancer, where we believe our medicines could have life-altering impact. For more information, visit www.parabilismed.com or follow us on LinkedIn.

Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are forward-looking statements. These include, without limitation, statements regarding: the design, initiation, enrollment and timing of the planned PEDESTAL Phase 3 trial of zolucatetide in desmoid tumors, including expected initiation in the first half of 2027 and topline results anticipated in 2029; our interactions with the U.S. Food and Drug Administration (FDA) regarding the dose and regimen, trial design and primary endpoint for registrational development; the ongoing Phase 1/2 trial of zolucatetide, including continued follow-up of participants; the potential therapeutic benefit, safety, tolerability and differentiation of zolucatetide, and its potential to expand the number of patients who may benefit from treatment; the potential benefits of Fast Track and Orphan Drug Designations; the development of zolucatetide in additional indications, including FAP, ACP, HCC and other Wnt-driven tumors; our strategy, plans and objectives.

Words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Forward-looking statements are based on management’s current expectations and assumptions. They are subject to risks, uncertainties and other important factors that could cause actual results to differ materially from those expressed or implied. These include, among others: the Phase 1/2 data described in this press release are interim, based on a June 22, 2026 data cutoff, and involve a limited number of patients, and may change as patients continue to be followed. Results of earlier clinical trials may not be predictive of results of later trials, including the PEDESTAL trial; FDA feedback on our development plans is not binding, may change and may not be sufficient to support marketing approval; the risk of delays or difficulties in initiating or enrolling clinical trials; the risk of unexpected adverse events or safety findings as more patients are treated for longer periods; Fast Track and Orphan Drug Designations may not lead to faster development, regulatory review or approval.

For a further discussion of these and other risks, see “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, as well as our subsequent filings with the Securities and Exchange Commission. Any forward-looking statement in this press release speaks only as of the date of this press release. Except as required by law, we undertake no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Disclosure:

Dr. Gounder has financial interests related to Parabilis Medicines.

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Posted on October 24, 2026 8:03 am
Semtech Brings 5G Network Slicing, FIPS 140-3 to IACP 2026

Semtech Brings 5G Network Slicing, FIPS 140-3 to IACP 2026

AirLink 5G Solutions Keep First Responders Connected During Peak Network Demand

CAMARILLO, Calif.–(BUSINESS WIRE)–
Semtech Corporation (Nasdaq: SMTC), a leading provider of high-performance semiconductors powering AI data center networking and intelligent, connected Internet of Things (“IoT”) devices worldwide, is adding new resilient communications building blocks to its AirLink® 5G Networking Solutions. Semtech will demonstrate the new capabilities in booth #2964 at the International Association of Chiefs of Police (IACP) conference in Orlando, Fla.

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Semtech’s AirLink XR60, XR80 and XR90 in-vehicle 5G routers support network slicing, FIPS 140-3 and fleet management for public safety agencies.

First responders rely on in-vehicle connectivity for computer-aided dispatch, live video and mobile data. When a mass-casualty incident, large-scale event or natural disaster pushes commercial networks to capacity, public safety traffic can get caught in the same congestion. In a recent survey, 64% of first responders named unreliable network connectivity as their single biggest concern (Source: T-Mobile, “5G and Public Safety: Transforming Emergency Response with T-Priority,” T-Mobile Newsroom, 2025).

“Resilient communication is not a capacity problem; it’s a priority and a data security problem,” said Kinana Hussein, vice president of networking solutions at Semtech. “AirLink networking solutions help address both. Network slicing support gives public safety dedicated, prioritized access to network resources, and AirLink OS 6.1 helps agencies meet FIPS 140-3 through a software update, with no hardware replacement.”

AirLink XR90, XR80 and XR60 Routers

The AirLink XR90, XR80 and XR60 in-vehicle 5G routers are built for public safety fleets. All three are FirstNet Trusted™ for use on FirstNet, built with AT&T, and certified for both T-Mobile’s T-Priority and Verizon’s Frontline network slices, giving agencies dedicated, prioritized access to emergency network resources on either carrier.

FIPS 140-3 and Zero Trust

With the new AirLink OS 6.1 operating system release, compatible AirLink routers can meet the new Federal Information Processing Standards (FIPS) 140-3 through a software update, with no hardware replacement required. FIPS 140-3 replaces FIPS 140-2, whose certificates the National Institute of Standards and Technology’s Cryptographic Module Validation Program (CMVP) moved to its Historical List on Sept. 21, 2026. Semtech’s Zero Trust architecture builds on its recently announced integration with Palo Alto Networks Next-Generation Firewalls.

Fleet Management Built to Scale

New fleet management groups in Semtech’s AirLink Management Service platform let administrators set the software and configuration standard for each device model, check compliance across the fleet immediately and correct devices that are not configured to the standard. AirLink Manager / AirLink Mobility Manager 2.18.1 extends that flexibility further, adding on-premises management options across the full AirLink OS portfolio, so agencies can manage fleets in the cloud or air-gapped.

Semtech at IACP 2026 Booth 2964

Greg Hill, Semtech director of product management, AirLink Networking Solutions, and Dan Robinson, Semtech director of AirLink government sales and a former police chief, will present “5G Network Slicing, Satellite, Zero Trust: The New Building Blocks of Resilient Communications” on Monday, Oct. 26 from 3:15–3:45 PM EDT. At booth #2964, attendees can see an interactive network slicing demonstration, Semtech’s cloud and on-premises management platforms and integrations with in-vehicle technology providers.

About Semtech

Semtech Corporation (Nasdaq: SMTC) is a leading provider of high-performance semiconductors powering AI data center networking, IoT connectivity and intelligent connected devices worldwide. Our global teams are committed to empowering solution architects and application developers to develop breakthrough products for the infrastructure, industrial and consumer markets. To learn more, visit Semtech.com or follow us on LinkedIn or X.

Semtech, the Semtech logo and AirLink are registered trademarks or service marks of Semtech Corporation or its subsidiaries. All other trademarks, service marks and trade names mentioned in this press release are the property of their respective owners.

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Semtech’s AirLink XR60, XR80 and XR90 in-vehicle 5G routers support network slicing, FIPS 140-3 and fleet management for public safety agencies.

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Posted on October 24, 2026 7:04 am
Genmab and Incyte Announce Clinical Trial Collaboration in Metastatic Colorectal Cancer

Genmab and Incyte Announce Clinical Trial Collaboration in Metastatic Colorectal Cancer

Phase 1/2 study will evaluate petosemtamab plus INCB161734 and standard-of-care chemotherapy in first-line KRAS G12D-mutated metastatic colorectal cancer (mCRC)

COPENHAGEN, Denmark & WILMINGTON, Del.–(BUSINESS WIRE)–Genmab A/S (Nasdaq: GMAB) and Incyte (Nasdaq: INCY) today announced a clinical trial collaboration to evaluate petosemtamab, Genmab’s investigational IgG1-bispecific antibody targeting the epidermal growth factor receptor (EGFR) and leucine-rich repeat containing G-protein-coupled receptor 5 (LGR5), in combination with INCB161734, Incyte’s investigational, potent and selective KRAS G12D inhibitor, and standard-of-care chemotherapy as a first-line treatment for patients with metastatic colorectal cancer harboring a KRAS G12D mutation, an area with substantial unmet medical need.

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“This collaboration supports our broader development strategy for petosemtamab as we explore its potential across treatment settings and in novel combinations,” said Judith Klimovsky, M.D., Executive Vice President and Chief Development Officer, Genmab. “Partnering with Incyte enables us to evaluate this investigational combination in patients with KRAS G12D-mutated metastatic colorectal cancer, reflecting our commitment to research collaborations aimed at expanding potential treatment options for more patients.”

“Metastatic colorectal cancer remains difficult-to-treat, underscoring the importance of evaluating novel combinations grounded in complementary scientific approaches with the potential to enhance efficacy,” said Pablo J. Cagnoni, M.D., President, Incyte and Global Head of Research and Development. “Our collaboration with Genmab will explore the potential of combining KRAS G12D inhibition with LGR5-targeted EGFR inhibition and standard-of-care chemotherapy, with the goal of advancing a new first-line treatment approach for patients with metastatic colorectal cancer.”

Under the collaboration, Genmab will conduct the Phase 1/2 study evaluating petosemtamab in combination with INCB161734 and standard-of-care chemotherapy in patients with KRAS G12D-mutated mCRC in the first-line setting. Incyte will co-fund the study and provide clinical supply of INCB161734.

KRAS mutations occur in approximately 40% of colorectal cancers, with G12D being the most common KRAS mutation. These cancers are associated with poor prognosis, underscoring the need for new treatment approaches. The collaboration reflects a shared focus on investigating whether agents with distinct and potentially complementary mechanisms, combined with standard-of-care chemotherapy, may offer a path toward a new treatment option for patients with KRAS G12D-mutated metastatic colorectal cancer.

About Petosemtamab (GEN1158)

Petosemtamab is an investigational human IgG1-based bispecific antibody targeting the EGFR and the LGR5 and designed to support multiple anti-tumor mechanisms. It inhibits EGFR-mediated signaling by engaging a unique site on the receptor to prevent ligand binding. In addition, petosemtamab triggers EGFR degradation in cancer stem-like cells expressing both EGFR and LGR5. Petosemtamab is also engineered to enhance innate immune-mediated activity through interactions with macrophages and natural killer cells. It is currently being investigated in head and neck squamous cell carcinoma (HNSCC) and other solid tumors, including colorectal cancer (CRC). Petosemtamab is being evaluated in combination with chemotherapy in two Phase 3 trials in first- and second-line RAS/BRAF wild-type metastatic CRC. Please visit https://clinicaltrials.gov/ for more information.

About INCB161734

INCB161734 is an investigational, novel, selective and orally bioavailable small molecule ON/OFF KRAS G12D inhibitor. KRAS is one of the most frequently altered oncogenic drivers across solid tumors, and the KRAS G12D mutation is among the most common KRAS alterations, occurring in approximately 40% of pancreatic ductal adenocarcinoma (PDAC) cases and approximately 15% of colorectal cancer (CRC) cases.

INCB161734 is being evaluated in the global Phase 3 DAWN-303 (NCT07522073) study which is currently enrolling patients with previously untreated KRAS G12D-mutated pancreatic ductal adenocarcinoma (PDAC) to further evaluate the efficacy and safety of INCB161734 in combination with standard-of-care (SoC) chemotherapy.

INCB161734 is also being evaluated as a monotherapy and in combination with standard-of-care (SoC) chemotherapy (gemcitabine/nab-paclitaxel [GEMNabP] or modified FOLFIRINOX [mFOLFIRINOX]), in an ongoing open-label Phase 1 study across KRAS G12D-mutated solid tumors (NCT06179160).

About Genmab

Genmab is an international biotechnology company dedicated to improving the lives of people with cancer and other serious diseases through innovative antibody medicines. For over 25 years, its passionate, innovative and collaborative team has advanced a broad range of antibody-based therapeutic formats, including bispecific antibodies, antibody–drug conjugates (ADCs), immune-modulating antibodies and other next-generation modalities. Genmab’s science powers eight approved antibody medicines, and the company is advancing a strong late-stage clinical pipeline, including wholly owned programs, with the goal of delivering transformative medicines to patients.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com or follow us on LinkedIn, X, Facebook and Instagram.

About Incyte^®
Incyte is redefining what’s possible in biopharmaceutical innovation. Through deep scientific expertise and a relentless focus on patients, we have built an established portfolio of first-in-class medicines and an extensive portfolio of next-generation medicines across our key franchises: Hematology, Oncology and Inflammation & Autoimmunity.

To learn more, visit Incyte.com and Investor.Incyte.com. Follow us on social media: LinkedIn, X and Instagram.

Genmab Forward-Looking Statements

This Media Release contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.comand the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab^®; the Y-shaped Genmab logo^®; Genmab in combination with the Y-shaped Genmab logo^®; HuMax^®; DuoBody^®; HexaBody^®; DuoHexaBody^®, HexElect^®and KYSO^®.

Incyte Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding Incyte’s clinical trial collaboration with Genmab; the design, initiation, timing, conduct, sponsorship and funding of the planned studies; the potential presented by INCB161734, petosemtamab and the combination of these investigational therapies with standard-of-care chemotherapy; the potential for the combination to provide a new treatment option for patients with first-line KRAS G12D-mutated metastatic colorectal cancer; expectations regarding the initiation, timing, progress and results of ongoing and planned clinical trials for INCB161734; whether or when INCB161734, petosemtamab or any combination regimen will be approved or commercially available for use in humans anywhere in the world; Incyte’s oncology portfolio and development strategy; and Incyte’s aspirations and goals as set forth under the heading “About Incyte.”

Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including whether preclinical or early clinical results will be replicated in later-stage or larger clinical trials; the sufficiency of clinical trial data to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and to enroll subjects in accordance with planned schedules; changes in clinical development plans; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and regulatory approval; the efficacy or safety of Incyte’s products and product candidates; Incyte’s ability to successfully develop and commercialize its product candidates; Incyte’s reliance on third parties and collaboration partners, including with respect to the planned studies described herein; the availability and effectiveness of competing treatments; Incyte’s ability to obtain and maintain protection of intellectual property for its products and technology; greater than expected expenses, including expenses relating to clinical development, litigation or strategic activities; and those risks and uncertainties discussed in greater detail in Incyte’s reports filed with the U.S. Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2025 and its quarterly report on Form 10-Q for the quarter ended June 30, 2026. Incyte disclaims any intent or obligation to update these forward-looking statements.

View source version on businesswire.com: https://www.businesswire.com/news/home/20261024542855/en/

Genmab Contacts

Media:

Jyoti Sharma, Director, Global Communications & Corporate Affairs

T: +1 609 480 9844; E: [email protected]

Investor Relations:

Andrew Carlsen, Vice President, Head of Investor Relations

T: +45 3377 9558; E: [email protected]

Incyte Contacts

Media

[email protected]

Investors

[email protected]

KEYWORDS: Delaware Europe Denmark United States North America

INDUSTRY KEYWORDS: Oncology Health Clinical Trials Research Science Pharmaceutical Biotechnology

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Posted on October 24, 2026 7:03 am
NANOBIOTIX Announces Final Data from Phase 1 Study Evaluating JNJ-1900 (NBTXR3) With Immune Checkpoint Inhibitors as a 2L+ Therapy in Anti-PD-1-Resistant Primary Cutaneous Melanoma

In 24 heavily pre-treated patients with advanced primary cutaneous melanoma whose cancer had progressed after multiple prior lines of therapy including anti-PD-1 therapy, data continue to show an acceptable safety profile and early signals of efficacy

41.7% (10/24) overall response rate (ORR) per RECIST 1.1, including 4 complete responses

75% (18/24) disease control rate (DCR)

17.8 months median Overall Survival

Exploratory analysis in a subset of patients (n=8) identified IL-1β, a cytokine linked to treatment-induced anti-tumor immunity, as the most increased plasma cytokine after treatment

Investigators concluded that these preliminary findings warrant further evaluation in randomized clinical trials for patients with primary cutaneous melanoma naïve or refractory to anti-PD-1

Data presented at the 2026 Congress of the European Society for Medical Oncology

PARIS and CAMBRIDGE, Mass., Oct. 24, 2026 (GLOBE NEWSWIRE) — NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the “Company”), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer and other major diseases, today announced updated results from patients with anti-PD-1-resistant advanced primary cutaneous melanoma treated in the ongoing Phase 1 Study 1100. The study evaluates JNJ-1900 (NBTXR3), which works in the presence of radiotherapy, followed by an immune checkpoint inhibitor (nivolumab or pembrolizumab) in patients with advanced solid tumors. The data were presented by Jason Chan, MD, Associate Professor, Department of Radiation Oncology, UCSF Helen Diller Family Comprehensive Cancer Center, in a poster session on Saturday, October 24, 2026, at the 2026 Annual Meeting of the European Society for Medical Oncology (“ESMO”) in Madrid, Spain.

ABSTRACT #3956: Safety and Anti-Tumor Activity of NBTXR3/SBRT with Immune Checkpoint Inhibitors in Anti-PD-1 Resistant Melanoma: Results from a Phase I Dose Expansion

^{J. Chan, J. Lee, A. Lam, A. Daud, F. Collichio, H. Yu, P. Mody, J. Weiss, S. Moschos, S. Powell, S. Peck, M. Lohr, E. Redstone, Z. Li, W. Smith, A. Juloori, R. Gineste, D. Rolando, A. Rosenberg and C. Shen. UCSF Helen Diller Family Comprehensive Cancer Center; UNC Lineberger Comprehensive Cancer Center, The University of North Carolina at Chapel Hill; Sanford Cancer Center; St Luke’s University Hospital; The University of Chicago; Nanobiotix}

Patients with advanced anti-PD-1 resistant primary cutaneous melanoma whose disease has progressed after multiple prior lines of therapy have a poor prognosis; published series report a median progression-free survival of approximately three months¹ and a median overall survival of approximately one year² in this setting. Melanoma has historically been considered radioresistant, and higher radiation doses are often limited by exposure of the surrounding healthy tissue.

“Patients whose melanoma has progressed on anti-PD-1 therapy, and often on several other immunotherapies as well, have limited options left,” said Jason Chan, MD, Associate Professor, Department of Radiation Oncology, UCSF Helen Diller Family Comprehensive Cancer Center “In this study, a single injection followed by a short course of stereotactic radiotherapy was feasible across a wide range of tumor sizes and locations, and we saw responses in lesions that were injected and in lesions that were not. The observed increase in IL-1βsuggests treatment-related immune activation that warrants further investigation. These are early data from a single-arm study, and they support testing the approach in a randomized trial.”

All 24 heavily pre-treated patients had advanced primary cutaneous melanoma resistant to anti-PD-1; 14 had stage IV disease. Most had received other immunotherapies before enrolling, including anti-CTLA-4 (50%), anti-LAG-3 (33.3%) and T-VEC (25%), and 87.5% had received immunotherapy as their most recent therapy. Patients received a one-time intratumoral injection of JNJ-1900 (NBTXR3) at the recommended Phase 2 dose (33% of gross tumor volume), followed by stereotactic body radiotherapy (“SBRT”) to the injected lesion and then nivolumab or pembrolizumab. Investigators observed an acceptable safety profile and early signals of efficacy.

Safety and Feasibility

Treatment consisting of a single intratumoral JNJ-1900 (NBTXR3) injection, followed by a short course of radiotherapy was feasible across a wide range of melanoma lesions, providing a minimally invasive treatment approach with an acceptable safety profile. No new safety signals have been observed.

Preliminary Efficacy

An Overall Response Rate (ORR) of 41.7% (10/24 patients) was observed. Responses were observed in both injected (ORR 45.8%; 11/24 evaluable patients) and non-injected lesions (ORR 30.0%; 3/10 evaluable patients).

Median Progression Free Survival (PFS) was 6.9 months, while median Overall Survival reached 17.8 months.

Exploratory Immune Profiling

In an exploratory analysis of plasma samples from a subset of patients (n=8), IL-1β showed the largest increase from baseline among the cytokines evaluated. Published research has linked IL-1β to treatment-induced anti-tumor immunity through its role in connecting innate immune activation to the priming of tumor-specific CD8+ T cells.³

“This updated analysis, with more patients and longer follow-up, builds on the first data we reported with consistent safety and an improvement in Overall Survival relative to the first data reported,” said Louis Kayitalire, MD, Chief Medical Officer of Nanobiotix. “Responses were again seen in patients whose disease had progressed after multiple prior therapies, including in lesions that were not injected. Together with the exploratory cytokine data, these findings warrant further evaluation of JNJ-1900 (NBTXR3) followed by anti-PD-1 therapy in patients with anti-PD-1-resistant melanoma.”

Overall, the acceptable safety profile and early efficacy observed by investigators in these preliminary findings provide promising signals of activity and warrant further evaluation in larger randomized trials.

About JNJ-1900 (NBTXR3)

JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles administered via one-time intratumoral injection and designed to work in the presenced of radiotherapy. The product candidate’s mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when in the presence of radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Proof-of-concept was demonstrated in a randomized Phase 2/3 soft tissue sarcoma study sponsored by Nanobiotix in 2018.

JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumor indications as a single agent or combination therapy. Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating JNJ-1900 (NBTXR3) across tumor types and therapeutic combinations.

In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy.

In 2023, Nanobiotix announced a license agreement for the global development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson company. Studies being led by Johnson & Johnson include NANORAY-312 (NCT04892173), a global, randomized Phase 3 study in platinum-based chemotherapy-ineligible, locally advanced head and neck squamous cell cancers; LUMIRAY (NCT07219212), a global, phase 1b, open-label study in locally advanced head and neck squamous cell cancers; and CONVERGE (NCT06667908), a phase 2, randomized, open-label, active-controlled study in locally advanced and unresectable Stage III non-small cell lung cancer (NSCLC).

About NANOBIOTIX

Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients; supported by people committed to making a difference for humanity. The Company’s philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life.

Incorporated in 2003, Nanobiotix is headquartered in Paris, France and is listed on Euronext Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020. The Company has subsidiaries in Cambridge, Massachusetts (United States) amongst other locations.

Nanobiotix is the owner of more than 30 umbrella patents associated with three (3) nanotechnology platforms with applications in 1) oncology; 2) bioavailability and biodistribution; and 3) disorders of the central nervous system.

For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter

Disclaimer

This press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the use of proceed therefrom, and the period of time through which the Company’s anticipates its financial resources will be adequate to support operations. Words such as “expects”, “intends”, “can”, “could”, “may”, “might”, “plan”, “potential”, “should” and “will” or the negative of these and similar expressions are intended to identify forward-looking statements. These forward-looking statements which are based on the Company’ management’s current expectations and assumptions and on information currently available to management. These forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those implied by the forward-looking statements, including risks related to Nanobiotix’s business and financial performance, which include the risk that assumptions underlying the Company’s cash runway projections are not realized. Further information on the risk factors that may affect company business and financial performance is included in Nanobiotix’s Annual Report on Form 20-F filed with the SEC on March 31, 2026 under “Item 3.D. Risk Factors”, in Nanobiotix’s 2025 universal registration document filed with the AMF on March 31, 2026 under “chapter 1.5 Risk Factors”, and subsequent filings Nanobiotix makes with the SEC and AMF from time to time, including the Half-Year Report at June 30, 2026, which are available on the SEC’s website at www.sec.gov and on the AMF’s website at www.amf.org, The forward-looking statements included in this press release speak only as of the date of this press release, and except as required by law, Nanobiotix assumes no obligation to update these forward-looking statements publicly.

Nanobiotix

Communications Department

Brandon Owens

VP, Communications

[email protected]

Investor Relations Department

Joanne Choi

VP, Investor Relations (US)

[email protected]

Ricky Bhajun
Director, Investor Relations (EU)
[email protected]

Media Relations

France – HARDY
Caroline Hardy
+33 06 70 33 49 50
[email protected]
Global – uncapped
Becky Lauer
+1 (646) 286-0057
[email protected]

________________

_{¹

Patrinely

JR

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_{., Cancer. 2020}

_{²

Nordstrom BL, Future Oncol. 18:1343-1355, 2022}

_{³

Ghiringhelli et al. Nat Med. 15(10):1170-8, 2009}

Attachment

PR_Study 1100 Melanoma Data ESMO 2026

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