Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer with PD-L1 ≥ 1 %: A subgroup analysis from the EMPOWER-Lung 3 part 2 trial.

Objectives: EMPOWER-Lung 3 part 2 (NCT03409614), a double-blind, placebo-controlled phase 3 study, assessed cemiplimab (anti-programmed cell death protein 1) plus chemotherapy versus chemotherapy alone in patients with advanced non-small cell lung cancer (NSCLC) without EGFR, ALK, or ROS1 aberrations, regardless of histology or PD-L1 expression levels. We report results from subgroup analysis of patients with PD-L1 expression ≥ 1 %.
Materials and Methods: Patients were randomized to receive cemiplimab 350 mg or placebo with chemotherapy every 3 weeks for up to 108 weeks. Overall survival (OS), progression-free survival (PFS), overall response rates (ORRs), patient-reported outcomes (PROs), and safety were assessed.
Results: Of the 327 patients with PD-L1 ≥ 1 % (466 in the overall study), 217 received cemiplimab plus chemotherapy and 110 received chemotherapy alone. After median follow-up of 28.0 months, median OS for cemiplimab plus chemotherapy was 23.5 months (95 % confidence interval [CI]: 20.9-27.2) vs. 12.1 months (95 % CI: 10.1-15.7) for chemotherapy alone (hazard ratio [HR] = 0.51, 95 % CI: 0.38-0.69, P < 0.0001); median PFS was 8.3 months (95 % CI: 6.7-10.8) versus 5.5 months (95 % CI: 4.3-6.2; HR = 0.48; 95 % CI: 0.37-0.62, P < 0.0001), and ORR was 47.9 % versus 22.7 %, respectively. PRO results favored cemiplimab plus chemotherapy over chemotherapy alone. Improved efficacy over chemotherapy alone was observed in both squamous and non-squamous histology. Safety was consistent with previous reports.
Conclusion: In this subgroup analysis from EMPOWER-Lung 3 part 2, cemiplimab plus chemotherapy demonstrated clinical benefit over chemotherapy alone in patients with advanced squamous or non-squamous NSCLC with PD-L1 ≥ 1 %.
Competing Interests: Declaration of competing interest A. Baramidze, M. Gogishvili, T. Melkadze, D. Giorgadze, K. Laktionov, G. Nemsadze, M. Nechaeva, and I. Rozhkova report no conflicts of interest.T. Makharadze reports travel support from Regeneron Pharmaceuticals, Inc.K. Penkov reports honoraria from AstraZeneca, Merck Sharp & Dohme, Nektar, Pfizer, Regeneron Pharmaceuticals, Inc. and Roche.E. Kalinka reports honoraria from: BMS, Merck Sharpe & Dohme, Roche, AstraZeneca, Regeneron Pharmaceuticals, Inc., Nektar, Pfizer, and Amgen; travel support from Regeneron Pharmaceuticals, Inc., Gilead, Merck Sharpe & Dohme, and BMS.D. McIntyre, J. Perez, M. Kaul, R. Quek, F. Seebach, P. Rietschel, and J-F. Pouliot are employees and shareholders of Regeneron Pharmaceuticals, Inc.
(Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)