FDA Approval Summary: Pembrolizumab, Atezolizumab, and Cemiplimab-rwlc as Single Agents for First-Line Treatment of Advanced/Metastatic PD-L1–High NSCLC
Author:
Akinboro Oladimeji1ORCID, Larkins Erin1, Pai-Scherf Lee H.1, Mathieu Luckson N.1, Ren Yi1, Cheng Joyce1, Fiero Mallorie H.1, Fu Wentao1, Bi Youwei1, Kalavar Shyam2, Jafri Samina2, Mishra-Kalyani Pallavi S.1, Fourie Zirkelbach Jeanne1, Li Hongshan1, Zhao Hong1, He Kun1, Helms Whitney S.1, Chuk Meredith K.1, Wang Min1, Bulatao Ilynn1, Herz Jonathan1, Osborn Blaire L.1, Xu Yuan1ORCID, Liu Jiang1, Gong Yutao1, Sickafuse Sharon1, Cohen Rebecca1ORCID, Donoghue Martha13ORCID, Pazdur Richard13, Beaver Julia A.13, Singh Harpreet13
Affiliation:
1. 1Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland. 2. 2Center for Devices and Radiological Health, U.S. Food and Drug Administration (FDA), Silver Spring, Maryland. 3. 3Oncology Center of Excellence, U.S. Food and Drug Administration (FDA), Silver Spring, Maryland.
Abstract
Abstract
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-L1 agents were supported by statistically significant and clinically meaningful improvements in overall survival (OS) in international, multicenter, active-controlled randomized trials. In KEYNOTE-024, the OS HR was 0.60 [95% confidence interval (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 progression-free survival (PFS) effect sizes for these anti–PD-L1 antibodies were also comparable across their respective registrational trials, and their safety profiles were consistent with the anti–PD-L1 class adverse event profile. The consistent survival benefits and manageable toxicity profiles of these single-agent anti–PD-L1 antibodies have established them as important treatment options in the PD-L1–high NSCLC treatment landscape. FDA approvals of these anti–PD-L1 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.
Funder
HHS | U.S. Food and Drug Administration
Publisher
American Association for Cancer Research (AACR)
Subject
Cancer Research,Oncology
Cited by
37 articles.
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