Merck: Phase 3 KEYNOTE-042 trial met primary endpoint of overall survival
Merck announced that the pivotal Phase 3 KEYNOTE-042 trial evaluating KEYTRUDA, Merck's anti-PD-1 therapy, as monotherapy for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, met its primary endpoint of overall survival. An interim analysis conducted by the independent Data Monitoring Committee demonstrated that treatment with KEYTRUDA resulted in significantly longer OS than platinum-based chemotherapy in patients with a PD-L1 tumor proportion score of greater than or equal to 1%. As part of a pre-specified analysis plan, OS was sequentially tested and was significantly improved in patients with a TPS of greater than or equal to 50%, with a TPS of greater than or equal to 20% and then in the entire study population with a TPS of greater than or equal to 1%. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported monotherapy studies involving patients with advanced NSCLC. Based on the recommendation of the DMC, the trial will continue to evaluate progression-free survival, which is a secondary endpoint. Results from KEYNOTE-042 will be presented at an upcoming medical meeting and submitted to regulatory authorities worldwide.