Arcus Biosciences(US:RCUS)2025-10-06 14:00Casdatifan Program Highlights - Arcus Biosciences has $927 million in cash to fund pivotal readouts for domvanalimab, quemliclustat, and casdatifan, including the PEAK-1 study[13] - Casdatifan targets a $2 billion+ peak sales opportunity in IO-experienced ccRCC (PEAK-1) and a $3 billion+ peak sales opportunity in 1L ccRCC (eVOLVE-RCC002)[24] - Casdatifan monotherapy in late-line ccRCC shows a confirmed overall response rate (cORR) of 31% across all pooled cohorts (n=121), exceeding the 22% observed with belzutifan in LITESPARK-005[47] - Median progression-free survival (mPFS) for the pooled casdatifan monotherapy cohorts (n=121) is 122 months, more than double the 56 months seen with belzutifan in LITESPARK-005[67] Clinical Trial Updates - PEAK-1, a Phase 3 trial evaluating casdatifan plus cabozantinib in IO-experienced ccRCC, is currently enrolling with a target of approximately 700 patients[109] - The Phase 1b/3 eVOLVE-RCC002 study, sponsored by AstraZeneca, is evaluating casdatifan plus volrustomig in 1L advanced ccRCC, with Phase 1b currently enrolling[122] Biomarker Analysis - Serum EPO (sEPO) reduction is a strong marker for HIF-2α activity in ccRCC tumors, with a median best EPO reduction of 85% from baseline[154] - Patients with deeper sEPO reduction (>=85%) showed a cORR of 446% compared to 203% in those with less deep reduction[145] - Patients with deeper sEPO reduction (>=85%) had a mPFS of 146 months compared to 96 months in those with less deep reduction, with a hazard ratio of 060[150] Market Opportunity - The RCC market is projected to reach $13 billion by 2030, driven by increasing patient population, HIF-2α MOA introduction, and longer durations of therapy[198] - Arcus Biosciences estimates a potential $5 billion+ opportunity for casdatifan in 1L and IO-experienced ccRCC[204]