{"id":1013071,"date":"2026-10-23T07:33:01","date_gmt":"2026-10-23T11:33:01","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/izalontamab-brengitecan-iza-bren-reduced-risk-of-disease-progression-or-death-by-59-versus-chemotherapy-in-patients-with-advanced-hr-her2-breast-cancer-in-phase-3-panku-breast01-study\/"},"modified":"2026-10-23T07:33:01","modified_gmt":"2026-10-23T11:33:01","slug":"izalontamab-brengitecan-iza-bren-reduced-risk-of-disease-progression-or-death-by-59-versus-chemotherapy-in-patients-with-advanced-hr-her2-breast-cancer-in-phase-3-panku-breast01-study","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/izalontamab-brengitecan-iza-bren-reduced-risk-of-disease-progression-or-death-by-59-versus-chemotherapy-in-patients-with-advanced-hr-her2-breast-cancer-in-phase-3-panku-breast01-study\/","title":{"rendered":"Izalontamab Brengitecan (Iza-Bren) Reduced Risk of Disease Progression or Death by 59% versus Chemotherapy in Patients with Advanced HR+\/HER2- Breast Cancer in Phase 3 PANKU-Breast01 Study"},"content":{"rendered":"

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Izalontamab Brengitecan (Iza-Bren) Reduced Risk of Disease Progression or Death by 59% versus Chemotherapy in Patients with Advanced HR+\/HER2- Breast Cancer in Phase 3 PANKU-Breast01 Study<\/b><\/p>\n

Late-breaking results to be presented in an oral presentation at ESMO 2026<\/i><\/b><\/p>\n

With two positive Phase 3 trials in breast cancer, these data reinforce the potential of iza-bren to further redefine treatment across breast cancer subtypes<\/i><\/b><\/p>\n

Iza-bren, a potentially first-in-class dual-targeting EGFRxHER3 bispecific antibody-drug conjugate, has now demonstrated clinical benefit in five distinct tumor types<\/i><\/b><\/p>\n

BOTHELL, Wash. & PRINCETON, N.J.–(BUSINESS WIRE<\/a>)–SystImmune, Inc.<\/a> (SystImmune), a clinical-stage biotechnology company, and Bristol Myers Squibb <\/a>(NYSE: BMY) today announced that SystImmune\u2019s parent company Sichuan Biokin Pharmaceutical, Ltd. (Biokin) reported positive results from a prespecified interim analysis of the randomized Phase 3 PANKU-Breast01 study (NCT06343948) evaluating izalontamab brengitecan (iza-bren), an investigational, potentially first-in-class, dual-targeting EGFRxHER3 bispecific antibody-drug conjugate (ADC), versus chemotherapy in patients with unresectable locally advanced, recurrent or metastatic hormone receptor-positive (HR+)\/HER2-negative (HER2-) breast cancer who have failed at least one prior line of chemotherapy. Results will be presented today in a late-breaking oral presentation at the European Society for Medical Oncology (ESMO) 2026 Annual Congress taking place October 23\u201327 in Madrid, Spain, and simultaneously published in The Lancet<\/i>.<\/p>\n

\nWith a median follow-up for progression-free survival (PFS) of 15.2 months, results showed iza-bren (n=190) reduced the risk of disease progression or death, the study\u2019s primary endpoint, by 59%, with median PFS vs. chemotherapy (n=193) of 8.2 months vs. 4.0 months as assessed by Blinded Independent Central Review (BICR) [HR: 0.41; 95% CI: 0.33-0.53, p<0.0001]. Overall survival, a key secondary endpoint of the study, was immature at the time of interim analysis. Confirmed objective response rate (cORR) by BICR was 40.5% with iza-bren vs. 20.2% with chemotherapy, and median duration of response (mDOR) was 6.9 months vs. 4.2 months, respectively.<\/p>\n

\n\u201cWhile there have been advances in the treatment landscape for HR-positive, HER2-negative advanced breast cancer, options can become increasingly limited as patients progress through available therapies, with most ultimately relying on chemotherapy,\u201d said Professor Binghe Xu, Academician of the Chinese Academy of Engineering, Cancer Hospital Chinese Academy of Medical Sciences. \u201cPANKU-Breast01 provides encouraging evidence for a new therapeutic approach. Unlike other ADCs, izalontamab brengitecan is designed to target both EGFR and HER3, and the reduction in the risk of disease progression or death suggests it could offer patients a meaningful new treatment option.\u201d<\/p>\n

\nThe safety profile for iza-bren was manageable and no new safety signals were identified. Grade \u22653 treatment-related adverse events (TRAEs) were predominantly hematologic in nature. TRAEs were manageable with supportive care, and only 1.6% of patients discontinued iza-bren treatment due to TRAEs. Adjudicated interstitial lung disease (ILD) occurred in two (1.1%) patients with iza-bren (Grade 1 or 2).<\/p>\n

\n\u201cThe 59% reduction in progression or death we see with iza-bren represents a substantial advance for patients who have limited treatment options after prior chemotherapy,\u201d said Dr. Jonathan Cheng, Chief Medical Officer of SystImmune. \u201cThis Phase 3 data, combined with our positive results in triple-negative breast cancer, demonstrates that our dual EGFRxHER3-targeting approach can meaningfully address the biology of multiple breast cancer subtypes and represents an important step towards more effective, precision-based treatment strategies.\u201d<\/p>\n

\n\u201cThe positive PANKU-Breast01 results are an important validation of iza-bren\u2019s potential as an innovative scientific approach to overcome disease resistance and the limitations of currently available treatment options,\u201d said Cristian Massacesi, MD<\/a>, executive vice president, chief medical officer and head of development, Bristol Myers Squibb. \u201cTogether with the clinical benefit iza-bren has shown in other tumor types, these data position iza-bren as a potentially first-in-class dual-targeting ADC therapy with the potential to become a new standard of care across the cancer treatment paradigm.\u201d<\/p>\n

\nIza-bren has demonstrated clinical benefit in five Phase 3 trials across five distinct indications, including previously-treated HR+\/HER2-negative breast cancer, previously-treated EGFR-mutated non-small cell lung cancer, nasopharyngeal carcinoma after prior treatment, previously-treated esophageal squamous cell carcinoma, and advanced triple-negative breast cancer, underscoring iza-bren\u2019s broad therapeutic potential in areas of critical unmet need. Iza-bren has also received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for previously-treated advanced EGFR-mutated NSCLC.<\/p>\n

\nThe PANKU-Breast01 study is sponsored by SystImmune\u2019s parent company, Sichuan Biokin Pharmaceutical Co., Ltd. (Biokin), in Mainland China. Outside of China, iza-bren is jointly developed by SystImmune and Bristol Myers Squibb under a collaboration and exclusive license agreement.<\/p>\n

About izalontamab brengitecan (iza-bren)<\/b><\/p>\n

\nIzalontamab brengitecan (iza-bren, BL-B01D1) is a bispecific antibody-drug conjugate (ADC) that targets both EGFR and\/or HER3, antigens that are highly expressed in various epithelial cancers and are known to be associated with cancer cell proliferation and survival. Upon target binding and internalization, iza-bren’s therapeutic novel Topo1i payload is released, causing cytotoxic stress that leads to cancer cell death. Iza-bren’s dual mechanism of action also blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. Iza-bren is being developed under a license and collaboration agreement by and between SystImmune and Bristol Myers Squibb.<\/p>\n

About SystImmune<\/b><\/p>\n

\nSystImmune is a clinical-stage biotechnology company located in Bothell, WA. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has several assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development.<\/b><\/p>\n

About Bristol Myers Squibb: Transforming Patients\u2019 Lives Through Science<\/b><\/p>\n

\nAt 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\u2019s possible for the future of medicine and the patients we serve. For more information, visit us at BMS.com<\/a> and follow us on LinkedIn<\/a>, X<\/a>, YouTube<\/a>, Facebook<\/a> and Instagram<\/a>.<\/p>\n

Bristol Myers Squibb Cautionary Statement Regarding Forward-Looking Statements<\/b><\/p>\n

This press release contains \u201cforward-looking statements\u201d 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 our 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 our 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 future study results may not be consistent with the results to date, that izalontamab brengitecan (iza-bren) may not achieve its primary study endpoints or receive regulatory approvals 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 such treatment for such indication 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\u2019s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb\u2019s Annual Report on Form 10-K for the year ended December 31, 2025, as updated by our 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.<\/i><\/p>\n

\ncorporatefinancial-news<\/p>\n

\"\"<\/p>\n

View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20261022086856\/en\/<\/a><\/span><\/p>\n

Bristol Myers Squibb<\/p>\n

<\/b>Media Relations
\n
<\/b>media@bms.com
\n<\/a><\/p>\n

Investor Relations
\n
<\/b>investor.relations@bms.com
\n<\/a><\/p>\n

SystImmune
\n
<\/b>media@systimmune.com<\/a><\/p>\n

KEYWORDS:<\/b> Washington New Jersey United States North America<\/p>\n

INDUSTRY KEYWORDS:<\/b> Biotechnology Health Pharmaceutical Clinical Trials Oncology<\/p>\n

MEDIA:<\/b><\/p>\n\n\n\n\n
Logo<\/b><\/font><\/td>\n<\/tr>\n
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Izalontamab Brengitecan (Iza-Bren) Reduced Risk of Disease Progression or Death by 59% versus Chemotherapy in Patients with Advanced HR+\/HER2- Breast Cancer in Phase 3 PANKU-Breast01 Study Late-breaking results to be presented in an oral presentation at ESMO 2026 With two positive Phase 3 trials in breast cancer, these data reinforce the potential of iza-bren to further redefine treatment across breast cancer subtypes Iza-bren, a potentially first-in-class dual-targeting EGFRxHER3 bispecific antibody-drug conjugate, has now demonstrated clinical benefit in five distinct tumor types BOTHELL, Wash. & PRINCETON, N.J.–(BUSINESS WIRE)–SystImmune, Inc. (SystImmune), a clinical-stage biotechnology company, and Bristol Myers Squibb (NYSE: BMY) today announced that SystImmune\u2019s parent company Sichuan Biokin Pharmaceutical, Ltd. (Biokin) reported positive results from a prespecified interim analysis of the … <\/p>\n

Continue reading “Izalontamab Brengitecan (Iza-Bren) Reduced Risk of Disease Progression or Death by 59% versus Chemotherapy in Patients with Advanced HR+\/HER2- Breast Cancer in Phase 3 PANKU-Breast01 Study”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-1013071","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nIzalontamab Brengitecan (Iza-Bren) Reduced Risk of Disease Progression or Death by 59% versus Chemotherapy in Patients with Advanced HR+\/HER2- Breast Cancer in Phase 3 PANKU-Breast01 Study - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/izalontamab-brengitecan-iza-bren-reduced-risk-of-disease-progression-or-death-by-59-versus-chemotherapy-in-patients-with-advanced-hr-her2-breast-cancer-in-phase-3-panku-breast01-study\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Izalontamab Brengitecan (Iza-Bren) Reduced Risk of Disease Progression or Death by 59% versus Chemotherapy in Patients with Advanced HR+\/HER2- Breast Cancer in Phase 3 PANKU-Breast01 Study - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Izalontamab Brengitecan (Iza-Bren) Reduced Risk of Disease Progression or Death by 59% versus Chemotherapy in Patients with Advanced HR+\/HER2- Breast Cancer in Phase 3 PANKU-Breast01 Study Late-breaking results to be presented in an oral presentation at ESMO 2026 With two positive Phase 3 trials in breast cancer, these data reinforce the potential of iza-bren to further redefine treatment across breast cancer subtypes Iza-bren, a potentially first-in-class dual-targeting EGFRxHER3 bispecific antibody-drug conjugate, has now demonstrated clinical benefit in five distinct tumor types BOTHELL, Wash. & PRINCETON, N.J.–(BUSINESS WIRE)–SystImmune, Inc. (SystImmune), a clinical-stage biotechnology company, and Bristol Myers Squibb (NYSE: BMY) today announced that SystImmune\u2019s parent company Sichuan Biokin Pharmaceutical, Ltd. (Biokin) reported positive results from a prespecified interim analysis of the … Continue reading "Izalontamab Brengitecan (Iza-Bren) Reduced Risk of Disease Progression or Death by 59% versus Chemotherapy in Patients with Advanced HR+\/HER2- Breast Cancer in Phase 3 PANKU-Breast01 Study"\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/izalontamab-brengitecan-iza-bren-reduced-risk-of-disease-progression-or-death-by-59-versus-chemotherapy-in-patients-with-advanced-hr-her2-breast-cancer-in-phase-3-panku-breast01-study\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2026-10-23T11:33:01+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20261022086856r1&sid=flmnd&distro=nx&lang=en\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"7 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/izalontamab-brengitecan-iza-bren-reduced-risk-of-disease-progression-or-death-by-59-versus-chemotherapy-in-patients-with-advanced-hr-her2-breast-cancer-in-phase-3-panku-breast01-study\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/izalontamab-brengitecan-iza-bren-reduced-risk-of-disease-progression-or-death-by-59-versus-chemotherapy-in-patients-with-advanced-hr-her2-breast-cancer-in-phase-3-panku-breast01-study\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Izalontamab Brengitecan (Iza-Bren) Reduced Risk of Disease Progression or Death by 59% versus Chemotherapy in Patients with Advanced HR+\\\/HER2- Breast Cancer in Phase 3 PANKU-Breast01 Study\",\"datePublished\":\"2026-10-23T11:33:01+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/izalontamab-brengitecan-iza-bren-reduced-risk-of-disease-progression-or-death-by-59-versus-chemotherapy-in-patients-with-advanced-hr-her2-breast-cancer-in-phase-3-panku-breast01-study\\\/\"},\"wordCount\":1378,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/izalontamab-brengitecan-iza-bren-reduced-risk-of-disease-progression-or-death-by-59-versus-chemotherapy-in-patients-with-advanced-hr-her2-breast-cancer-in-phase-3-panku-breast01-study\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&sty=20261022086856r1&sid=flmnd&distro=nx&lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/izalontamab-brengitecan-iza-bren-reduced-risk-of-disease-progression-or-death-by-59-versus-chemotherapy-in-patients-with-advanced-hr-her2-breast-cancer-in-phase-3-panku-breast01-study\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/izalontamab-brengitecan-iza-bren-reduced-risk-of-disease-progression-or-death-by-59-versus-chemotherapy-in-patients-with-advanced-hr-her2-breast-cancer-in-phase-3-panku-breast01-study\\\/\",\"name\":\"Izalontamab Brengitecan (Iza-Bren) Reduced Risk of Disease Progression or Death by 59% versus Chemotherapy in Patients with Advanced HR+\\\/HER2- Breast Cancer in Phase 3 PANKU-Breast01 Study - 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(SystImmune), a clinical-stage biotechnology company, and Bristol Myers Squibb (NYSE: BMY) today announced that SystImmune\u2019s parent company Sichuan Biokin Pharmaceutical, Ltd. (Biokin) reported positive results from a prespecified interim analysis of the … Continue reading \"Izalontamab Brengitecan (Iza-Bren) Reduced Risk of Disease Progression or Death by 59% versus Chemotherapy in Patients with Advanced HR+\/HER2- Breast Cancer in Phase 3 PANKU-Breast01 Study\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/izalontamab-brengitecan-iza-bren-reduced-risk-of-disease-progression-or-death-by-59-versus-chemotherapy-in-patients-with-advanced-hr-her2-breast-cancer-in-phase-3-panku-breast01-study\/","og_site_name":"Market Newsdesk","article_published_time":"2026-10-23T11:33:01+00:00","og_image":[{"url":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20261022086856r1&sid=flmnd&distro=nx&lang=en","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"7 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/izalontamab-brengitecan-iza-bren-reduced-risk-of-disease-progression-or-death-by-59-versus-chemotherapy-in-patients-with-advanced-hr-her2-breast-cancer-in-phase-3-panku-breast01-study\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/izalontamab-brengitecan-iza-bren-reduced-risk-of-disease-progression-or-death-by-59-versus-chemotherapy-in-patients-with-advanced-hr-her2-breast-cancer-in-phase-3-panku-breast01-study\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Izalontamab Brengitecan (Iza-Bren) Reduced Risk of Disease Progression or Death by 59% versus Chemotherapy in Patients with Advanced HR+\/HER2- Breast Cancer in Phase 3 PANKU-Breast01 Study","datePublished":"2026-10-23T11:33:01+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/izalontamab-brengitecan-iza-bren-reduced-risk-of-disease-progression-or-death-by-59-versus-chemotherapy-in-patients-with-advanced-hr-her2-breast-cancer-in-phase-3-panku-breast01-study\/"},"wordCount":1378,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/izalontamab-brengitecan-iza-bren-reduced-risk-of-disease-progression-or-death-by-59-versus-chemotherapy-in-patients-with-advanced-hr-her2-breast-cancer-in-phase-3-panku-breast01-study\/#primaryimage"},"thumbnailUrl":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20261022086856r1&sid=flmnd&distro=nx&lang=en","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/izalontamab-brengitecan-iza-bren-reduced-risk-of-disease-progression-or-death-by-59-versus-chemotherapy-in-patients-with-advanced-hr-her2-breast-cancer-in-phase-3-panku-breast01-study\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/izalontamab-brengitecan-iza-bren-reduced-risk-of-disease-progression-or-death-by-59-versus-chemotherapy-in-patients-with-advanced-hr-her2-breast-cancer-in-phase-3-panku-breast01-study\/","name":"Izalontamab Brengitecan (Iza-Bren) Reduced Risk of Disease Progression or Death by 59% versus Chemotherapy in Patients with Advanced HR+\/HER2- Breast Cancer in Phase 3 PANKU-Breast01 Study - 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