Arcus Biosciences(US:RCUS)2025-08-06 20:05Pipeline and Programs - Arcus Biosciences has $927 million in cash, cash equivalents, and marketable securities as of June 30, 2025, funding operations through initial pivotal readouts for domvanalimab, quemliclustat, and casdatifan, including PEAK-1[10] - Casdatifan plus cabozantinib showed a confirmed ORR of 46% in patients who reached a minimum of 12 weeks of follow-up in IO-experienced ccRCC[16] - In first-line PDAC, a Phase 1 study showed a median overall survival (mOS) of 157 months (n=122) for patients treated with a quemliclustat-based regimen, exceeding historical benchmarks for chemotherapy alone (85 – 117 months)[108] - The company is targeting substantial market opportunities with three late-stage programs: Post-IO ccRCC ($2B), IO-naive ccRCC ($3B), 1L Gastric/GEJ/EAC ($3B), 1L NSCLC ($10B), and 1L PDAC (>$4B)[12] Casdatifan (HIF-2α Inhibitor) - Casdatifan plus cabozantinib in IO-experienced ccRCC demonstrated a high confirmed overall response rate (cORR) of 46% with a low rate of primary progression of 4%[29] - Casdatifan monotherapy in 2L+ ccRCC showed a confirmed ORR ranging from 21% to 33% across three cohorts, with median progression-free survival (PFS) of 97 months in the 50mg BID cohort[53] - Casdatifan achieves similar PD effect (EPO suppression) at only 20mg, one-fifth the "going forward" dose of 100mg[21] Domvanalimab (Anti-TIGIT mAb) - In the Phase 2 EDGE-Gastric study, patients with TAP ≥ 5% had a median PFS of 138 months, while those with TAP < 5% had a median PFS of 113 months[82] - In 1L PD-L1 High NSCLC, domvanalimab + zimberelimab showed a median PFS of 93 months compared to 54 months for zimberelimab alone, with a HR of 067[90] - In 1L PD-L1 High NSCLC, domvanalimab + zimberelimab showed a HR of 064 for overall survival (OS) compared to zimberelimab alone[90] Partnerships - Arcus retains co-promotion rights and profit share in the US, with high-teens to low-20's royalties on ex-US sales[19] - Taiho has development/commercial rights in Japan and the rest of Asia (ex-China), with up to $275 million in milestones per program and high single-digit to mid-teens royalties[19]