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Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial
Abstract
Background We aimed to examine cemiplimab, a programmed cell death 1 inhibitor, in the first-line treatment of advanced non-small-cell lung cancer with programmed cell death ligand 1 (PD-L1) of at least 50%.Methods In EMPOWER-Lung 1, a multicentre, open-label, global, phase 3 study, eligible patients recruited in 138 clinics from 24 countries (aged ≥18 years with histologically or cytologically confirmed advanced non-small-cell lung cancer, an Eastern Cooperative Oncology Group performance status of 0-1; never-smokers were ineligible) were randomly assigned (1:1) to cemiplimab 350 mg every 3 weeks or platinum-doublet chemotherapy. Crossover from chemotherapy to cemiplimab was allowed following disease progression. Primary endpoints were overall survival and progression-free survival per masked independent review committee. Primary endpoints were assessed in the intention-to-treat population and in a prespecified PD-L1 of at least 50% population (per US Food and Drug Administration request to the sponsor), which consisted of patients with PD-L1 of at least 50% per 22C3 assay done according to instructions for use. Adverse events were assessed in all patients who received at least one dose of the assigned treatment. This study is registered with ClinicalTrials.gov, NCT03088540 and is ongoing.Findings Between June 27, 2017 and Feb 27, 2020, 710 patients were randomly assigned (intention-to-treat population). In the PD-L1 of at least 50% population, which consisted of 563 patients, median overall survival was not reached (95% CI 17·9-not evaluable) with cemiplimab (n=283) versus 14·2 months (11·2-17·5) with chemotherapy (n=280; hazard ratio [HR] 0·57 [0·42-0·77]; p=0·0002). Median progression-free survival was 8·2 months (6·1-8·8) with cemiplimab versus 5·7 months (4·5-6·2) with chemotherapy (HR 0·54 [0·43-0·68]; p<0·0001). Significant improvements in overall survival and progression-free survival were also observed with cemiplimab in the intention-to-treat population despite a high crossover rate (74%). Grade 3-4 treatment-emergent adverse events occurred in 98 (28%) of 355 patients treated with cemiplimab and 135 (39%) of 342 patients treated with chemotherapy.Interpretation Cemiplimab monotherapy significantly improved overall survival and progression-free survival compared with chemotherapy in patients with advanced non-small-cell lung cancer with PD-L1 of at least 50%, providing a potential new treatment option for this patient population.Funding Regeneron Pharmaceuticals and Sanofi.
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“It may result in better OS and PFS compared to platinum-based chemotherapy in patients with advanced NSCLC, indicating a possible new treatment option for these patients [51].”
From Immune Checkpoint Inhibitors in Cancer Therapy (2022) · cites this paper as [51]
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Metadata
- Authors
- Sezer, A., Kilickap, S., Gümüş, M., Bondarenko, I., Özgüroğlu, M., Gogishvili, M., Turk, H. M., Cicin, I., Bentsion, D., Gladkov, O., Clingan, P., Sriuranpong, V., Rizvi, N., Gao, B., Li, S., Lee, S., McGuire, K., Chen, C.-I., Makharadze, T., Paydas, S., Nechaeva, M., Seebach, F., Weinreich, D. M., Yancopoulos, G. D., Gullo, G., Lowy, I., & Rietschel, P.
- Affiliations
- Başkent University (TR)
- Istanbul Medeniyet University (TR)
- Dnipro State Medical University (UA)
- Istanbul University-Cerrahpaşa (TR)
- University of Wollongong (AU)
- Chulalongkorn University (TH)
- Columbia University Irving Medical Center (US)
- Regeneron (United States) (US)
- Arkhangel'skiy Klinicheskiy Onkologicheskiy Dispanser (RU)
- Corresponding author
- Sezer, Ahmet
- ORCID
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2021-02
- Volume
- 397
- Issue
- 10274
- Pages
- 592-604
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W3129022890
- Cited by
- 789
- References
- 31
- Citations by year
- 2026: 52 · 2025: 133 · 2024: 164 · 2023: 197 · 2022: 167 · 2021: 74
- FWCI
- 54.84
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- Research Online (University of Wollongong) (submittedVersion)
- Trakya University's Institutional Open Access System (Trakya University) (submittedVersion)
- Funders
- Sanofi
- Regeneron Pharmaceuticals
- Topics
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Oncology › Lung Cancer Research Studies
- Keywords
- cemiplimab, non-small cell lung cancer, PD-L1 expression, PD-1 inhibitors, first-line therapy, platinum-based chemotherapy, overall survival, progression-free survival, immune checkpoint inhibitors, treatment crossover, adverse events, immune-related adverse events, immunotherapy versus chemotherapy, never smokers
- MeSH terms
- Pemetrexed, Antineoplastic Agents, Immunological, Progression-Free Survival, Immune Checkpoint Inhibitors, Gemcitabine, Aged, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Cisplatin, Deoxycytidine, Female, Humans, Lung Neoplasms, Male, Middle Aged, Survival Rate, Carboplatin, Paclitaxel, B7-H1 Antigen, Antibodies, Monoclonal, Humanized
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