FDA Approval Summary: Pembrolizumab, Atezolizumab, and Cemiplimab-rwlc as single agents for first-line treatment of advanced/metastatic PD-L1 high NSCLC

FDA's approval of cemiplimab-rwlc on February 22, 2021 follows prior approvals of pembrolizumab and atezolizumab for similar indications - as first-line treatment for patients with programmed death ligand-1 (PD-L1)-high advanced non-small cell lung cancer (NSCLC). Approvals of these anti-PD-(L)-1 agents were supported by statistically significant and clinically meaningful improvements in overall survival (OS) in international, multi-center, active-controlled randomized trials. In KEYNOTE-024, the OS hazard ratio (HR) was 0.60 (95% [CI]: 0.41, 0.89; p=0.005) favoring pembrolizumab over platinum-doublet chemotherapy. In IMpower110, the OS HR was 0.59 (95% CI: 0.40, 0.89; p=0.0106) favoring atezolizumab over platinum-doublet chemotherapy. In Study 1624, the OS HR was 0.68 (95% CI: 0.53, 0.87; p=0.0022) favoring cemiplimab-rwlc over platinum-doublet chemotherapy. The PFS effect sizes for these anti-PD-(L)-1 antibodies were also comparable across their respective registrational trials, and their safety profiles were consistent with the anti-PD-(L)-1 class adverse event profile. The consistent survival benefits and manageable toxicity profiles of these single agent anti-PD-(L)-1 antibodies have established them as important treatment options in the PD-L1 high NSCLC treatment landscape. FDA approvals of these anti-PD-(L)-1 antibodies, based on their favorable benefit-risk profiles, present effective chemotherapy-free therapeutic options for patients with advanced PD-L1 high NSCLC in the United States.