On April 23, 2025 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, reported that data from the ARC-20 study will be presented in an oral session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 30 – June 3, 2025 (Press release, Arcus Biosciences, APR 23, 2025, View Source [SID1234652074]).
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The oral presentation will highlight the first safety and efficacy data for the ARC-20 expansion cohort evaluating the HIF-2a inhibitor casdatifan plus cabozantinib, an anti-vascular endothelial growth factor receptor 2 tyrosine kinase inhibitor (VEGFR2-TKI), in patients with ccRCC that had previously been treated with immunotherapy alone or in combination with anti-VEGFR2-TKI therapies.
"We are thrilled to be presenting the first combination data evaluating our HIF-2a inhibitor, casdatifan, in combination with cabozantinib in an oral presentation at ASCO (Free ASCO Whitepaper)," said Terry Rosen, Ph.D., chief executive officer of Arcus. "The data being presented support our rapidly advancing and differentiated development program for casdatifan, which includes the initiation of our Phase 3 trial, PEAK-1, that will evaluate the same combination as this cohort. The development plan also includes our clinical collaboration to evaluate casdatifan in combination with AstraZeneca’s PD-1/CTLA-4 bispecific antibody, volrustomig, in immuno-oncology-naive ccRCC patients. We look forward to presenting additional data from the ARC-20 study throughout the year."
Study
Title
Abstract Number
Session Type & Title
Session Date & Time
Casdatifan (HIF-2a Inhibitor)
ARC-20
Combination Casdatifan Plus Cabozantinib Expansion Cohort of Phase 1 ARC-20 Study in Previously Treated Patients with Clear Cell Renal Cell Carcinoma
4506
Oral Abstract Session – Genitourinary Cancer—Kidney and Bladder
6/01/2025,
9:45 AM – 12:45 PM CT
Investors may dial in to the conference call at +1 404 975 4839 (local) or +1 833 470 1428 (toll-free) using Conference ID: 446724 on Monday, June 2, 2025, at 5:00 AM PT / 7:00 AM CT. Participants may also register for the call online using the following link: View Source To access the live webcast and accompanying slide presentation, please visit the "Investors & Media" section of the Arcus Biosciences website at www.arcusbio.com. A replay will be available following the live event.
About RCC
According to the American Cancer Society, kidney cancer is among the top 10 most commonly diagnosed forms of cancer among both men and women in the U.S., and an estimated 80,980 Americans will be diagnosed with kidney cancer in 2025. Clear cell RCC is the most common type of kidney cancer in adults. If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 18%. In 2022, approximately 32,200 patients with advanced kidney cancer required systemic therapy in the U.S., with over 20,000 patients receiving first-line treatment.
About Casdatifan (AB521)
Casdatifan is a small-molecule inhibitor of HIF-2a, a transcription factor responsible for activating multiple tumor growth pathways in hypoxic and pseudo-hypoxic tumor environments. By selectively binding HIF-2⍺, casdatifan is designed to shut down hypoxic oncogenesis, which blocks tumor growth and key oncogenic pathways, leading to cancer cell death. Clear cell RCC (ccRCC) is almost universally associated with HIF-2a dysregulation. Casdatifan is currently being evaluated in ARC-20, a Phase 1/1b study in renal cell carcinoma and other cancers.
Casdatifan 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.