Merck: Phase 3 KEYNOTE-671 Trial With KEYTRUDA Meets One Of Its Dual Primary Endpoints

(RTTNews) - Merck (MRK) announced that the Phase 3 KEYNOTE-671 trial investigating KEYTRUDA 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. No new safety signals were observed in the trial. The company said the trial will continue to evaluate the other dual primary endpoint of overall survival.

"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," said Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories.

The FDA has accepted Merck's new supplemental Biologics License Application 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 PDUFA, or target action, date of October 16, 2023.

For More Such Health News, visit rttnews.com.