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Arcus Biosciences (RCUS) investor relations material
Arcus Biosciences R&D Day 2025 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Pipeline overview and program updates
Casdatifan is the lead program, prioritized due to strong scientific, clinical, and commercial validation, with five and soon six phase III studies ongoing across oncology and immunology indications.
Casdatifan, a HIF-2α inhibitor, is advancing through Phase 3 trials (PEAK-1, eVOLVE-RCC02) targeting clear cell renal cell carcinoma (ccRCC), with robust late-line monotherapy data supporting its best-in-class potential.
Late-stage pipeline includes anti-TIGIT (domvanalimab) and CD73 inhibitor (quemliclustat), both with promising data and rapid enrollment in global trials, with pivotal readouts expected in 2026.
Immunology and inflammation portfolio includes five active research programs, with the first IND/Phase 1 trial for MRGPRX2 expected in 2026 and additional candidates in 2027.
The company is well-funded, with over $900 million to support readouts from all late-stage programs and multiple value inflection points.
Clinical trial data and development milestones
Casdatifan monotherapy in late-line RCC/ccRCC shows a 31–35% confirmed ORR and median PFS over 12 months, outperforming belzutifan in response rate, PFS, and lower primary progression.
Combination studies (casdatifan + cabozantinib) show rapid, durable tumor reduction, high tolerability, and a 46% confirmed response in early data.
Biomarker analysis revealed that deeper erythropoietin (EPO) suppression by casdatifan correlates with higher ORR and longer PFS.
Phase III PEAK-1 (post-IO, casdatifan + cabozantinib) and eVOLVE (frontline, casdatifan + volrustomig) are actively enrolling, targeting the largest RCC market segments, with additional data expected throughout 2026.
Additional cohorts are exploring casdatifan in neoadjuvant, frontline, and TKI-naive settings.
R&D strategy and innovation priorities
Focus on best-in-class molecules, leveraging translational data to correlate EPO suppression with clinical outcomes.
Oncology and I&I strategy includes small-molecule improvements of cytokine-targeted therapeutics and novel approaches to mast cell and neutrophil biology.
Strategy includes rapid proof-of-concept in indications with high unmet need and competitive advantage in dosing and safety.
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