The FDA has accepted for priority review the supplemental biologics license application for pembrolizumab (Keytruda, Merck), an anti-programmed death-1 (PD-1) therapy, for the first-line treatment of patients with advanced non–small-cell lung cancer (NSCLC) whose tumors express programmed death ligand-1 (PD-L1). The FDA has also granted a breakthrough therapy designation for this indication, which has a target action date of December 24, 2016.
The submission was based on data from the pivotal phase 3 KEYNOTE-024 study, which showed that pembrolizumab monotherapy resulted in superior progression-free survival as well as superior overall survival compared with standard chemotherapy in patients with advanced NSCLC whose tumors expressed high levels of PD-L1 (tumor proportion scores of 50% or more). Based on these results, the trial was stopped early to give patients still on chemotherapy the opportunity to receive pembrolizumab. Merck filed for approval of pembrolizumab in the first-line setting at a dose of 200 mg every three weeks––the dose studied in the KEYNOTE-024 trial.
Pembrolizumab is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Pembrolizumab 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.
Pembrolizumab is indicated for the treatment of patients with unresectable or metastatic melanoma at a dosage of 2 mg/kg every three weeks. Pembrolizumab is also indicated 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, at a dosage of 2 mg/kg every three weeks. Further, pembrolizumab is indicated for the treatment of patients with recurrent or metastatic head-and-neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy at a fixed dosage of 200 mg every three weeks.
Pembrolizumab is administered as an intravenous infusion over 30 minutes every three weeks for the approved indications. Pembrolizumab for injection is supplied in a 100- mg single-use vial.
Source: Merck; September 7, 2016.