Gilead Sciences (Nasdaq: GILD) and Arcus Biosciences (NYSE:RCUS) are touting positive results 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 (NSCLC) at the American Society of Clinical Oncology (ASCO).
Patients in the arms who received the investigational Fc-silent anti-TIGIT monoclonal antibody domvanalimab had a reduction in risk of progression or death between 35% and 45%. They also had a doubling of median progression-free survival.
Patients in the study had a PD-L1 tumor proportion score (TPS) of 50% or greater without epidermal growth factor receptor or anaplastic lymphoma kinase (EGFR/ALK) mutations.
Patients in the domvanalimab received the drug with the investigational anti-PD1 monoclonal antibody zimberelimab (doublet arm) or were administered those two drugs in combination with the small-molecule, dual adenosine receptor antagonist etrumadenant (triplet arm).
Zimberelimab binds to PD-1 to support the antitumor activity of T cells.
Etrumadenant is an orally bioavailable antagonist of the immunomodulatory checkpoint molecules adenosine A2A receptor and A2B receptor.
Patients in the doublet and triplet arms had clinically meaningful improvements in median progression-free survival relative to zimberelimab monotherapy. Patients in the doublet arm had a 45% reduction in risk of disease progression or death. Conversely, patients in the triplet arm had a 35% reduction in risk.
“The preliminary improvements observed for each of the doublet and triplet regimens across multiple efficacy measures reinforce our confidence in the potential therapeutic benefit of inhibiting the TIGIT pathway and provide further support for the ongoing Phase 3 studies,” said Dr. Melissa L. Johnson, director, lung cancer research, Sarah Cannon Research Institute at Tennessee Oncology, and lead investigator for the ARC-7 study, in a news release.
Investigators in the study observed no unexpected safety signals across the three study arms at the time of data cutoff.
Arcus entered a license agreement in 2016 with Abmuno Agreement to obtain an exclusive license for domvanalimab.
Investigators conducted the interim analysis after a clinical data cutoff date of August 31, 2022. A total of 150 patients were randomized across the three study arms.
Filed Under: Oncology