\nArcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for the treatment of cancer and inflammatory diseases, announced today that it will host an in-person investor event with a live webcast on Tuesday, October 20, 2026, beginning at 8:30 AM ET, in New York City.<\/p>\n
\nThe event will highlight new data from the ARC-20 platform study, which is evaluating casdatifan, a next-generation HIF-2\u03b1 inhibitor, alone or in combination, as a first-, second- and late-line treatment for clear cell renal cell carcinoma (ccRCC). Featured presenters will include members of the Arcus management team and Dr. Rana McKay, Professor of Medicine and Urology at the University of California San Diego, who is a leading academic expert in the treatment of kidney cancer with deep experience using HIF-2\u03b1 inhibitors.<\/p>\n
\nNew data to be presented will include:<\/p>\n
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- \nFirst-line TKI-free combinations:<\/p>\n
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- Casdatifan plus zimberelimab (anti-PD-1 antibody<\/span>): Data will include safety and early efficacy, including rate of primary progression, overall response rate (ORR), and progression-free survival (PFS) for 30 patients with a median follow-up of approximately 11 months.\n<\/li>\n
- Casdatifan plus ipilimumab plus zimberelimab:<\/span> Data will include safety and rate of primary progression for approximately 20 patients. Safety data from this cohort will support initiation of the first-line registrational trial PEAK-20, evaluating casdatifan plus ipilimumab plus nivolumab, expected to occur in the fourth quarter of 2026.\n<\/li>\n<\/ul>\n<\/li>\n
- \nSecond-line TKI-containing combination:<\/p>\n
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- Casdatifan plus cabozantinib:<\/span> Efficacy data will include ORR, PFS, and early overall survival (OS) for 43 patients with a minimum of 18 months and a median of approximately 21 months of follow-up and a subgroup analysis of efficacy (including PFS and OS) based on prior therapy. Safety and tolerability data will also be provided for this cohort. This is the same combination and patient population being evaluated in the registrational trial PEAK-1, expected to be fully enrolled at the end of 2026.\n<\/li>\n<\/ul>\n<\/li>\n
- \nLate-line monotherapy:<\/p>\n
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- Casdatifan monotherapy:<\/span> Data will include OS, as well as updated ORR and PFS, for 121 patients in the pooled monotherapy cohorts, with median follow-up of approximately 28 months.\n<\/li>\n
- \nArcus will also be highlighting new subgroup analyses, including evaluation of casdatifan monotherapy efficacy for both PFS and OS by prior therapy. In addition, Arcus will share the first translational data correlating pharmacodynamic markers of HIF-2\u03b1 inhibition with overall survival.<\/p>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n
\nThe presentation will also include market opportunity and review of Arcus’s development strategy, which is designed to generate evidence to secure casdatifan as a backbone therapy in ccRCC so that every patient has the opportunity to benefit from casdatifan across each line of therapy over the course of their care.<\/p>\n
\nPlease contact Arcus Investor Relations regarding in-person attendance. The event will be broadcast live via webcast here: https:\/\/event.summitcast.com\/view\/oP6P82VnbjK87kUbV5QALF\/guest_book?session_id=WJm4z43QhGbWA8FEbbv5AM<\/a>. A replay will be available following the live event in the \u201cInvestors & Media\u201d section of the Arcus Biosciences website at www.arcusbio.com<\/a>.<\/p>\n
About Casdatifan (AB521)<\/b><\/p>\n
\nCasdatifan is a small-molecule inhibitor of hypoxia-inducible factor 2-alpha (HIF-2a), a master switch that turns on hundreds of genes in response to low oxygen levels. In a majority of people with the most common form of kidney cancer (clear cell renal cell carcinoma), genetic anomalies result in the dysregulation of this master switch and transformation of normal kidney cells into cancerous ones.<\/p>\n
\nCasdatifan was designed to provide deep and durable inhibition of the HIF-2a pathway. Early clinical studies have shown high response rates and a low primary progression rate relative to clinical benchmarks, warranting further investigation in late-stage studies. Casdatifan, which is administered in pill form once daily, has a safety profile that allows it to be investigated in combination with other treatments.<\/p>\n
\nThe casdatifan development strategy is designed to generate evidence needed to establish casdatifan as a backbone therapy so that every ccRCC patient has the opportunity to benefit from casdatifan across each line of therapy. In addition to partner-operationalized studies, including combinations with casdatifan and anti-PD-X\/VEGF bispecifics, Arcus is investigating casdatifan across multiple cohorts in the ARC-20 platform study, alone and in combination with other potential new treatment options, including in:<\/p>\n
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- \nThe first-line setting with cohorts evaluating casdatifan plus zimberelimab, an anti-PD-1 (ongoing); casdatifan plus zimberelimab and ipilimumab, an anti-CTLA-4 (ongoing); and casdatifan plus ivonescimab, an anti-PD-1\/VEGF bispecific (planned)<\/p>\n<\/li>\n
- \nThe second-line setting with a cohort evaluating casdatifan plus cabozantinib, a TKI, in immunotherapy-experienced patients (ongoing)<\/p>\n<\/li>\n
- \nThe late-line setting with a cohort evaluating casdatifan plus tivozanib, a TKI, in HIF-2a inhibitor-experienced patients (planned)<\/p>\n<\/li>\n<\/ul>\n
\nArcus is also enrolling PEAK-1, the global Phase 3 study evaluating casdatifan plus cabozantinib versus cabozantinib in immunotherapy-experienced patients with metastatic ccRCC. Arcus expects to complete enrollment in PEAK-1 and to initiate the Phase 3 PEAK-20 study in first-line metastatic ccRCC by year-end 2026.<\/p>\n
\nCasdatifan is an investigational molecule. Approval from any regulatory authority for its use has not been received, and its safety and efficacy have not been established. Taiho has development and commercial rights in Japan and other countries in Asia, excluding China. Arcus Biosciences holds full rights to casdatifan everywhere else globally.<\/p>\n
About Arcus Biosciences<\/b><\/p>\n
\nArcus Biosciences is a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules for the treatment of cancer and inflammatory diseases. In partnership with industry collaborators, patients and physicians around the world, Arcus is expediting the development of its late-stage portfolio of first- and\/or best-in-class medicines against well-characterized biological targets and pathways and studying novel, biology-driven combinations that have the potential to help people with cancer live longer. Founded in 2015, the company has advanced multiple investigational medicines into registrational clinical trials including casdatifan, a HIF-2\u03b1 inhibitor for clear cell renal cell carcinoma, and quemliclustat, a small-molecule CD73 inhibitor for pancreatic cancer. For more information about Arcus Biosciences\u2019 clinical and preclinical programs, please visit www.arcusbio.com<\/a>.<\/p>\n
Forward-Looking Statements<\/b><\/p>\n
\nThis press release contains forward-looking statements. All statements regarding events or results to occur in the future contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Arcus\u2019s expectations for the content of the investor presentation and the timing and achievement of milestones, including the completion of PEAK-1 and the initiation of PEAK-20. All forward-looking statements involve known and unknown risks and uncertainties and other important factors that may cause Arcus\u2019s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, risks associated with: difficulties or delays in initiating, enrolling and completing clinical trials, including due to regulatory review, site activation, patient identification or enrollment, or manufacturing and supply constraints of investigational or standard-of-care products for such clinical trials; changes in the competitive landscape for Arcus\u2019s programs; and the inherent uncertainty associated with pharmaceutical product development and clinical trials. Risks and uncertainties facing Arcus are described more fully in the \u201cRisk Factors\u201d section of Arcus\u2019s most recent periodic report filed with the U.S. Securities and Exchange Commission (SEC) and in other filings that Arcus makes with the SEC from time to time, which are available at www.sec.gov<\/a>. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Arcus disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release, except to the extent required by law.<\/p>\n
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View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20260922009299\/en\/<\/a><\/span><\/p>\n
Investor Inquiries
\n<\/b>
Pia Eaves
\n
VP of Investor Relations & Strategy
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(617) 459-2006
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peaves@arcusbio.com<\/a><\/p>\nMedia Inquiries
\n<\/b>
Holli Kolkey
\n
VP of Corporate Affairs
\n
(650) 922-1269
\n
hkolkey@arcusbio.com<\/a><\/p>\n
- \nArcus will also be highlighting new subgroup analyses, including evaluation of casdatifan monotherapy efficacy for both PFS and OS by prior therapy. In addition, Arcus will share the first translational data correlating pharmacodynamic markers of HIF-2\u03b1 inhibition with overall survival.<\/p>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n
- \nLate-line monotherapy:<\/p>\n
- Casdatifan plus ipilimumab plus zimberelimab:<\/span> Data will include safety and rate of primary progression for approximately 20 patients. Safety data from this cohort will support initiation of the first-line registrational trial PEAK-20, evaluating casdatifan plus ipilimumab plus nivolumab, expected to occur in the fourth quarter of 2026.\n<\/li>\n<\/ul>\n<\/li>\n
- Casdatifan plus zimberelimab (anti-PD-1 antibody<\/span>): Data will include safety and early efficacy, including rate of primary progression, overall response rate (ORR), and progression-free survival (PFS) for 30 patients with a median follow-up of approximately 11 months.\n<\/li>\n