Gilead, Arcus announce new data from Cohort B of ARC-9 mCRC study

Gilead Sciences (GILD) and Arcus Biosciences (RCUS) announced new data from Cohort B of ARC-9, a Phase 1b/2 study evaluating the safety and efficacy of etrumadenant, a dual A2a/b adenosine receptor antagonist, plus anti-PD-1 monoclonal antibody zimberelimab, FOLFOX chemotherapy and bevacizumab in third-line metastatic colorectal cancer. These results will be presented today during an oral session at the 2024 American Society of Clinical Oncology Annual Meeting. Cohort B of ARC-9 randomized 112 patients with comparable baseline characteristics between two arms: EZFB or regorafenib. At the time of data cut-off median follow-up was 20.4 months. Patient baseline characteristics were similar to those of third-line patients who have progressed on oxaliplatin- and irinotecan-based regimens in mCRC. OS and PFS were consistently longer in the EZFB arm versus regorafenib, in all sub-groups analyzed, including in patients with liver metastases. The EZFB regimen had a safety profile consistent with the known safety profiles of each individual molecule to date, without unexpected toxicities. A higher percentage of patients treated with regorafenib had a treatment emergent adverse event leading to discontinuation of all study drugs than those treated with EZFB. A lower percentage of patients experienced Grade greater than or equal to 3 TEAEs attributed to etrumadenant or zimberelimab versus regorafenib.