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Clinical Trial
. 2025 Jul;20(7):941-954.
doi: 10.1016/j.jtho.2025.03.033. Epub 2025 Mar 19.

Cemiplimab Monotherapy for First-Line Treatment of Patients with Advanced NSCLC With PD-L1 Expression of 50% or Higher: Five-Year Outcomes of EMPOWER-Lung 1

Saadettin Kilickap  1 , Ana Baramidze  2 , Ahmet Sezer  3 , Mustafa Özgüroğlu  4 , Mahmut Gumus  5 , Igor Bondarenko  6 , Miranda Gogishvili  7 , Marina Nechaeva  8 , Michael Schenker  9 , Irfan Cicin  10 , Ho Gwo Fuang  11 , Yaroslav Kulyaba  12 , Kasimova Zyuhal  13 , Roxana-Ioana Scheusan  14 , Marina Chiara Garassino  15 , Yuntong Li  16 , Cong Zhu  16 , Manika Kaul  16 , Javier Perez  16 , Frank Seebach  16 , Israel Lowy  16 , Jean-Francois Pouliot  16 , Eric Kim  16 , Heather Magnan  16
Affiliations
Free article
Clinical Trial

Cemiplimab Monotherapy for First-Line Treatment of Patients with Advanced NSCLC With PD-L1 Expression of 50% or Higher: Five-Year Outcomes of EMPOWER-Lung 1

Saadettin Kilickap et al. J Thorac Oncol. 2025 Jul.
Free article

Abstract

Introduction: Earlier results from the phase 3 EMPOWER-Lung 1 trial indicated significant survival benefits and a generally acceptable safety profile of first-line cemiplimab monotherapy versus chemotherapy for patients with advanced NSCLC with programmed cell death-ligand 1 (PD-L1) expression in 50% or more tumor cells and no EGFR, ALK, or ROS1 aberrations. Here, we report the five-year outcomes.

Methods: Patients were randomized 1:1 to cemiplimab 350 mg intravenously every three weeks for two years or the investigator's choice of chemotherapy. The primary endpoints were overall survival (OS) and progression-free survival.

Results: A total of 712 patients were randomized to cemiplimab (n = 357) or chemotherapy (n = 355). The median duration of follow-up was 59.6 months (interquartile range: 55.1-66.7 months) at the data cutoff (January 16, 2024). In patients with verified 50% or higher PD-L1 (n = 565), median OS was 26.1 months for cemiplimab versus 13.3 months for chemotherapy (hazard ratio = 0.59, 95% confidence interval [CI]: 0.48-0.72); the median progression-free survival was 8.1 months versus 5.3 months (hazard ratio = 0.50, 95% confidence interval: 0.41-0.61); and the objective response rate was 46.5% versus 20.6%. The five-year OS probability was 29.0% for cemiplimab and 15.0% for chemotherapy. Improved survival outcomes were observed with both squamous and nonsquamous histology, and increasing activity of cemiplimab was correlated with higher PD-L1 expression, with the highest PD-L1 expression having the best outcome. The safety profile remains consistent with previous results. Grade 3 or higher treatment-related adverse events occurred in 18.3% of patients for cemiplimab and 39.9% for chemotherapy.

Conclusions: At five-year follow-up, first-line cemiplimab monotherapy continued to show durable clinical benefits versus chemotherapy in patients with advanced NSCLC with 50% or higher PD-L1. Patients with 90% or higher PD-L1 derived the largest clinical benefits.

Keywords: Cemiplimab; Lung neoplasms; Non–small cell lung cancer; PD-L1; Programmed cell death-ligand 1 inhibitor.

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Conflict of interest statement

Disclosure Dr. Kilickap reports receiving meeting and travel support from Regeneron Pharmaceuticals, Inc. Dr. Özgüroğlu reports advisory board participation for Sanofi and Regeneron Pharmaceuticals, Inc.; and receiving travel and accommodation support from Regeneron Pharmaceuticals. Dr. Gümüş reports honoraria to institution for lectures from Roche, Merck Sharp & Dohme, Gen İlaç, and Novartis outside the submitted work. Dr. Schenker reports research grants from Regeneron Pharmaceuticals, Inc., Bristol Myers Squibb, MSD, Roche, Merck Serono, AstraZeneca, Eli Lilly, Astellas, Amgen, BeiGene, Bayer, Eisai, Pfizer, GSK, AbbVie, Bioven, Novartis, Clovis, Daichii Sankyo, PharmaMar, Tesaro, and Five Prime Therapeutics. Dr. Ho reports institutional grants from Regeneron Pharmaceuticals, Inc., MSD, AB Science, Astellas, Tessa Therapeutics, Roche, Arcus Bioscience, AstraZeneca, Pfizer, Janssen Research & Development, Mirati Therapeutics, Novartis, Amgen, and Boehringer Ingelheim; honoraria from MSD, Novartis, F. Hoffmann-La Roche AG, AstraZeneca, Boehringer Ingelheim, Pfizer, Merck & Co., Inc., and Eisai; meeting and travel support from Ipsen, AstraZeneca, Bristol Myers Squibb, MSD, Regeneron Pharmaceuticals, Inc., Dr. Reddy’s Laboratories, Roche, Servier, Zullig Pharma, and Pfizer; data safety monitoring or advisory board participation for MSD, Novartis, Roche, AstraZeneca, Boehringer Ingelheim, Pfizer, Astellas Pharma, Inc., and Takeda Pharmaceuticals; and institutional receipt of equipment, materials, drugs, medical writing, gifts, or other services from Pfizer, Novartis, Janssen Pharmaceuticals, Taiho, and Eli Lilly. Dr. Garassino reports grants from Merck; consulting fees from AstraZeneca, MSD International GmbH, Bristo Myers Squibb, Boehringer Ingelheim Italia S.p.A, Celgene, Eli Lilly, Ignyta, Incyte, Inivata, MedImmune, Novartis, Roche, Takeda, Seattle Genetics, Mirati, Daiichi Sankyo, Regeneron Pharmaceuticals, Inc., Merck, Pfizer (MISP), Celgene, Tiziana, Foundation Medicine, GSK, Spectrum Pharmaceuticals, AIRC, AIFA, the Italian Ministry of Health, and TRANSCAN; honoraria from AstraZeneca, MSD International GmbH, Bristol Myers Squibb, Boehringer Ingelheim Italia S.p.A, Celgene, Eli Lilly, Ignyta, Incyte, Inivata, MedImmune, Novartis, Roche, Takeda, Seattle Genetics, Mirati, Daiichi Sankyo, Regeneron Pharmaceuticals, Inc., Merck, Pfizer (MISP), Tiziana, Foundation Medicine, GSK, Spectrum Pharmaceuticals, AIRC, AIFA, the Italian Ministry of Health, and TRANSCAN; meeting and travel support from Merck; and data safety monitoring or advisory board participation for Eli Lilly, Pfizer (MISP), AstraZeneca, MSD International GmbH, Bristol Myers Squibb, Boehringer Ingelheim Italia S.p.A, Celgene, Ignyta, Incyte, MedImmune, Novartis, Roche, Takeda, Tiziana, Foundation Medicine, GSK, Spectrum Pharmaceuticals, AIRC, AIFA, the Italian Ministry of Health, and TRANSCAN. Drs. Li, Zhu, Kaul, Perez, Seebach, Lowy, Pouliot, Kim, and Magnan are employees of Regeneron Pharmaceuticals, Inc. and own stock or stock options. The remaining authors declare no conflict of interest.

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