FDA accepts sBLA for Keytruda (pembrolizumab) based on KEYNOTE-010 study in NSCLC confirmatory for full approval.-Merck Inc.

Merck has announced that the FDA has accepted for review a new supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, to include data from KEYNOTE-010. The trial was a pivotal Phase II/III study designed to evaluate Keytruda compared to chemotherapy based on prospective measurement of PD-L1 expression in previously treated patients with advanced non-small cell lung cancer. KEYNOTE-010 was published in The Lancet in December 2015.

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).

The NSCLC indication, approved under accelerated approval, was based on tumor response rate and durability of response in patients with PD-L1 expression on 50 percent or more of the cancer cells. Under accelerated approval, improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. In accordance with the accelerated approval process, the data from KEYNOTE-010 was intended to serve as the confirmatory trial for receiving full approval, establishing the clinical benefit by demonstrating improved survival over standard chemotherapy. Findings from this study were presented at the European Society for Medical Oncology (ESMO) Asia 2015 Congress and published in The Lancet .