Company: RCUS
Filing Date: 2025-10-28
Form Type: 10-Q
Source: 0001724521-25-000116
Chunk: 224

Company: Arcus Biosciences, Inc.
Filing Date: 2025-10-28
Form: 10-Q
Item: Part I, Item 1
Chunk 224
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 milestone payments upon the achievement of clinical, regulatory and commercialization milestones, and, additionally pay royalties on net sales.

HIF-2α Program (casdatifan)

•In October 2025, we presented new data for our HIF-2α inhibitor, casdatifan, across all four monotherapy cohorts (n=121) of the Phase 1/1b ARC-20 study in late-line metastatic kidney cancer, most of whom had progressed on at least two prior lines of therapy, including both an anti-PD-1 and a VEGFR tyrosine kinase inhibitor ("TKI"). At the time of data cut-off (August 15, 2025):

◦For the pooled analysis of all four monotherapy cohorts, with 15.2 months of median follow-up: median progression-free survival ("mPFS") was 12.2 months, the 18-month landmark PFS was 43%, the 12-month landmark PFS was 50% and the confirmed overall response rate ("cORR") was 31%.

◦For the 100mg QD cohort (the Phase 3 PEAK-1 dose and formulation), with 12.4 months of median follow-up: mPFS was not reached, the 18-month landmark PFS was not reached; the 12-month landmark PFS was 60% and the cORR was 35%.

◦No unexpected safety signals were observed at the time of DCO, and casdatifan had an acceptable and manageable safety profile across all doses. Across all four cohorts, one patient discontinued treatment due to anemia, and four patients (3%) discontinued due to hypoxia.

•In October 2025, we announced eVOLVE-RCC02, a Phase 1b/3 study sponsored and operationalized by AstraZeneca, evaluating casdatifan plus volrustomig, AstraZeneca's investigational anti-PD-1/CTLA-4 bispecific antibody, in first-line, metastatic clear cell renal cell carcinoma ("ccRCC"), has paused recruitment.

◦The Phase 1b portion of the study has recruited rapidly and in the context of this rapid enrollment, following observations of potentially immune-mediated adverse events ("AEs"), none of which exceeded Grade 3, a decision was made to temporarily pause recruitment, while continuing to treat participants already enrolled into the study. No grade 4 or 5 events were observed and the majority