Merck: KEYNOTE-671 Trial Meets Dual Primary Endpoint - Quick Facts

(RTTNews) - Merck (MRK) announced the Phase 3 KEYNOTE-671 trial investigating KEYTRUDA as a perioperative treatment regimen for patients with resectable stage II, IIIA or IIIB non-small cell lung cancer met its dual primary endpoint of overall survival. At a pre-specified interim analysis, KEYTRUDA plus chemotherapy before surgery, followed by resection and KEYTRUDA as a single agent after surgery, showed a statistically significant and clinically meaningful improvement in OS compared to neoadjuvant placebo plus chemotherapy followed by adjuvant placebo in these patients. The safety profile was consistent with that observed in previously reported studies.

Based on the data, the FDA has accepted Merck's new supplemental Biologics License Application with a PDUFA, or target action, date of October 16, 2023.

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