Company: RCUS
Filing Date: 2025-10-28
Form Type: 10-Q
Source: 0001724521-25-000116
Chunk: 340

Company: Arcus Biosciences, Inc.
Filing Date: 2025-10-28
Form: 10-Q
Item: Part I, Item 2
Chunk 340
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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 of AEs were grade 1 or 2.

◦We and AstraZeneca will continue to monitor these participants to further characterize the safety profile of the combination with longer follow-up. These data, along with any discussions with health authorities, will inform next steps for the study.

TIGIT Program (domvanalimab)

•In October 2025, we presented the first overall survival results from Arm A1 of the Phase 2 EDGE-Gastric study in patients with locally advanced unresectable or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma. At data cutoff (March 3, 2025), safety and efficacy were evaluated in all patients enrolled and treated (n=41) and median study follow-up was 26.4 months.

◦Median overall survival ("mOS") was 26.7 months in the overall patient population, 26.7 months in patients with PD-L1 expression ≥1% as measured by TAP scoring (SP263 assay) and not reached in patients with PD-L1 expression ≥5%.

◦No unexpected safety signals were observed at the time of data cut off. The safety profile of domvanalimab plus zimberelimab and chemotherapy was generally well tolerated and is consistent with that of anti-PD-1 plus chemotherapy. 

•Concurrent with our first presentation of this data at European Society for Medical Oncology ("ESMO") congress in October 2025, these data were published in Nature Medicine. 

Adenosine-Pathway Program (quemliclustat)

•In October 2025, we announced that we completed enrollment of PRISM-1, a Phase 3