Phase III KEYNOTE-024 trial of Keytruda (pembrolizumab) meets primary endpoint in non small cell lung cancer- Merck Inc

Merck Inc has announced that the KEYNOTE-024 trial investigating the use of Keytruda (pembrolizumab), in patients with previously untreated advanced non-small cell lung cancer (NSCLC) whose tumors expressed high levels of PD-L1 (tumor proportion score of 50 percent or more), met its primary endpoint. In this trial, Keytruda was superior compared to chemotherapy for both the primary endpoint of progression-free survival (PFS), and the secondary endpoint of overall survival (OS).

Based on these results, an independent Data Monitoring Committee (DMC) has recommended that the trial be stopped, and that patients receiving chemotherapy in KEYNOTE-024 be offered the opportunity to receive Keytruda. The safety profile of Keytruda in this trial was consistent with that observed in previously reported studies in patients with advanced NSCLC.

KEYNOTE-024 is a randomized, pivotal, phase III study (ClinicalTrials.gov, NCT02142738) evaluating Keytruda (pembrolizumab) monotherapy compared to standard of care (SOC) platinum-based chemotherapies in the treatment of patients with advanced NSCLC. Results from KEYNOTE-024 will be presented at an upcoming medical meeting.

Comment: Keytruda is currently indicated in the U.S. for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 as determined by an FDA-approved test with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Keytruda (pembrolizumab).