Merck announced the phase 3 KEYNOTE-671 trial investigating Keytruda (pembrolizumab), Merck’s anti-programmed death receptor-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 event-free survival compared to neoadjuvant placebo plus chemotherapy followed by adjuvant placebo, according to a press release from Merck.
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. The results will be presented at an upcoming medical meeting.
The US Food and Drug Administration (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 non-small cell lung cancer 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 date of Oct. 16.
“Results from KEYNOTE-671 show that Keytruda in combination with chemotherapy provided significant improvement in event-free survival, pathological complete response, and major pathological response over chemotherapy alone as a perioperative treatment regimen for patients with resectable stage II, IIIA, or IIIB non-small cell lung cancer,” says Eliav Barr, MD, senior vice president, head of global clinical development, and chief medical officer of Merck Research Laboratories, in a press release. “By moving this Keytruda-based regimen into earlier stages of non-small cell lung cancer, we may be able to significantly reduce the risk of recurrence for these patients. This study is an important milestone, and we look forward to sharing the detailed results with the medical community as soon as possible.”
Keytruda, a humanized monoclonal antibody, works by increasing the ability of the body’s immune system to help detect and fight tumor cells.