Gilead, Arcus provide update from fourth interim analysis of ARC-7 study

Gilead (GILD) and Arcus Biosciences (RCUS) announced an update from the fourth interim analysis of the randomized, open-label Phase 2 ARC-7 study in patients with first-line metastatic non-small cell lung cancer, or NSCLC, with PD-L1 tumor proportion score of 50% without epidermal growth factor receptor or anaplastic lymphoma kinase mutations. ARC-7 is evaluating the combinations of anti-TIGIT antibody domvanalimab plus anti-PD-1 antibody zimberelimab and domvanalimab plus zimberelimab and etrumadenant, an A2a/b adenosine receptor antagonist, versus zimberelimab alone, and represents the first randomized Phase 2 study of an Fc-silent anti-TIGIT/anti-PD-1 combination. The protocol-specified fourth interim analysis was conducted when the trial reached full enrollment, with a clinical data cutoff date of August 31. A total of 150 patients have been randomized across the three study arms. For the current interim analysis, efficacy was evaluated in study patients who had at least 13 weeks of potential follow-up and were eligible for at least two imaging scans. Both domvanalimab combinations continued to show clinically meaningful differentiation compared to zimberelimab monotherapy across multiple efficacy measures, including objective response rates, progression-free survival and six-month landmark PFS. Detailed results from this fourth interim analysis and an exploratory analysis on 12 patients who crossed over from zimberelimab monotherapy arm to triplet therapy will be presented on December 20, 2022, at the Monthly Plenary Series, a new virtual forum for presentation and discussion of the latest cancer research. According to ASCO, live presentations are accessible to virtual attendees and available on-demand, and abstract presentations are accompanied by a discussant presentation and followed by a live Q&A session. Abstracts accepted for the Monthly Plenary Session are also placed at the ASCO Annual Meeting in June 2023. During the ASCO Annual Meeting, additional results from further analysis of the ARC-7 dataset will be presented. Domvanalimab, zimberelimab and etrumadenant are investigational molecules and neither Arcus or Gilead have received approval from any regulatory authority for any use globally, including for the treatment of lung cancer. Their efficacy and safety for the treatment of lung cancer have not been established.