Merck, known as MSD outside the United States and Canada, announced that the US Food and Drug Administration (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 2/3 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.

“The data from KEYNOTE-010 demonstrated an overall survival benefit in patients with PD-L1 expression on one percent or more of the cancer cells,” said Roger Dansey, M.D., senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “We look forward to working with the FDA over the course of the application review process and remain committed to advancing our broad clinical program for cancers where patients are in need of new options, including lung cancer.”

Keytruda is currently indicated in the US 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.

Keytruda is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Keytruda blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Keytruda is indicated in the US for the treatment of patients with unresectable or metastatic melanoma.

Keytruda is also indicated for the treatment of patients with metastatic non-small cell lung cancer (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. The NSCLC indication is approved under accelerated approval based on tumor response rate and durability of response. An 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.

Keytruda is administered at a dose of 2 mg/kg as an intravenous infusion over 30 minutes every three weeks for the approved indications.