Arcus Biosciences Announces New Monotherapy Data For Casdatifan, HIF-2a Inhibitor With Potential, In Late-Line Metastatic Clear Cell Renal Cell Carcinoma

Author: Benzinga Newsdesk | October 06, 2025 07:12am

• Casdatifan data were better on every efficacy measure evaluated, across all four monotherapy cohorts (n=121) of the Phase 1/1b ARC-20 study in late-line metastatic kidney cancer, relative to published data from studies with the only marketed HIF-2a inhibitor
• Median progression-free survival (mPFS) was 12.2 months, and 18-month landmark PFS was 43% in the pooled analysis of all four monotherapy cohorts
• Confirmed overall response rate (ORR) was 35%, with two additional responses pending confirmation, and mPFS had not been reached in the 100mg QD cohort (the Phase 3 PEAK-1 dose and formulation)
• Five new research programs for autoimmune and inflammatory diseases are being announced; first clinical study is expected to be initiated in 2026
• The investor event will be webcast today beginning at 7:00 AM PT / 10:00 AM ET

Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, today announced new monotherapy data for casdatifan, a HIF-2a inhibitor with best-in-class potential, in late-line metastatic clear cell renal cell carcinoma (ccRCC). At an investor event hosted later today, the Company will share more detail on these data and preview the expansion of its research efforts into autoimmune and inflammatory diseases. Featured presenters will include members of the Arcus management team and key opinion leaders with expertise in HIF-2a biology and treatment of ccRCC.

Posted In: RCUS