The pivotal, phase 3 KEYNOTE-042 trial evaluating pembrolizumab (Keytruda), Merck’s anti-programmed death-1 (PD-1) therapy, as monotherapy for the first-line treatment of locally advanced or metastatic non–small-cell lung cancer (NSCLC, including nonsquamous or squamous histologies) met its primary endpoint of overall survival (OS). The study enrolled 1,274 patients randomized 1:1 to receive either pembrolizumab as monotherapy or investigator’s choice of platinum-based chemotherapy.
An interim analysis conducted by the independent data monitoring committee (DMC) demonstrated that treatment with pembrolizumab resulted in significantly longer OS than platinum-based chemotherapy (carboplatin plus paclitaxel or carboplatin plus pemetrexed) in patients with a programmed death ligand-1 (PD-L1) tumor proportion score (TPS) of 1% or greater. As part of a prespecified analysis plan, OS was sequentially tested and was significantly improved in patients with a TPS of 50% or greater, with a TPS of 20% or greater, and then in the entire study population with a TPS of 1% or greater. The safety profile of pembrolizumab in this trial was consistent with that observed in previously reported monotherapy studies involving patients with advanced NSCLC.
Based on the recommendation of the DMC, the trial will continue to evaluate progression-free survival (PFS), which is a secondary endpoint. Results from KEYNOTE-042 will be presented at an upcoming medical meeting and submitted to regulatory authorities worldwide.
Pembrolizumab is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Pembrolizumab is a humanized monoclonal antibody that 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.
Source: Merck; April 9, 2018.