Merck says Phase 3 KEYNOTE-671 trial met one of dual primary endpoints

Merck announced that the Phase 3 KEYNOTE-671 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, met one of its dual primary endpoints, event-free survival, as a perioperative treatment regimen for patients with resectable stage II, IIIA or IIIB non-small cell lung cancer. A perioperative treatment regimen includes treatment before surgery and continued after surgery. The trial will continue to evaluate the other dual primary endpoint of overall survival. At a prespecified interim analysis conducted by an independent Data Monitoring Committee, neoadjuvant KEYTRUDA plus chemotherapy followed by resection and adjuvant single-agent KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in EFS compared to neoadjuvant placebo plus chemotherapy followed by adjuvant placebo. Statistically significant improvements in the trial’s key secondary endpoints of pathological compete response and major pathological response were also demonstrated at this analysis. No new safety signals were observed. Results will be presented at an upcoming medical meeting. The U.S. FDA has accepted Merck’s new supplemental Biologics License Application based on these data for KEYTRUDA for the treatment of patients with resectable stage II, IIIA, or IIIB NSCLC in combination with platinum containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment. The FDA has set a Prescription Drug User Fee Act, or target action, date of October 16, 2023.