Phase III KEYNOTE-407 trial of Keytruda in metastatic squamous non-small cell lung cancer meets secondary endpoint and is filed with FDA.- Merck Inc.

Merck Inc. announced that the pivotal Phase III KEYNOTE-407 trial investigating Keytruda (pembrolizumab), in combination with carboplatin-paclitaxel or nab-paclitaxel as first line treatment for metastatic squamous non-small cell lung cancer (sNSCLC) met a pre-specified secondary endpoint of overall response rate (ORR) in an early cohort of participants at an interim analysis. Based on these data, Merck has recently submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA).

This study has been accepted for oral presentation at the American Society of Clinical Oncology (ASCO) 2018 Annual Meeting. The company now expects that an additional interim analysis will be conducted prior to ASCO and additional data may be available for the ASCO 2018 Annual Meeting.

Comment: In August 2016, Keytruda (2 mg/kg every three weeks) was approved in Europe for previously-treated patients with locally advanced or metastatic NSCLC whose tumors express PD-L1 (TPS of 1 percent or more) and who have received at least one prior chemotherapy regimen.