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

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dc.authoridBondarenko, Igor/0000-0002-7071-2471
dc.authoridBondarenko, Igor N/0000-0002-7071-2471
dc.authoridSEZER, AHMET/0000-0002-6445-1439
dc.authoridKilickap, Saadettin/0000-0003-1637-7390
dc.authoridMUSTAFA, ÖZGÜROĞLU/0000-0002-8417-8628
dc.authoridBondarenko, Igor/0000-0002-7071-2471
dc.authoridPaydas, Semra/0000-0003-4642-3693
dc.authorwosidBondarenko, Igor/U-5156-2017
dc.authorwosidBondarenko, Igor N/GQP-1497-2022
dc.authorwosidGumus, Mahmut/HTO-4176-2023
dc.authorwosidSEZER, AHMET/AAD-2667-2020
dc.authorwosidKilickap, Saadettin/AAP-3732-2021
dc.authorwosidMUSTAFA, ÖZGÜROĞLU/A-8234-2016
dc.authorwosidBondarenko, Igor/W-9412-2019
dc.contributor.authorSezer, Ahmet
dc.contributor.authorKilickap, Saadettin
dc.contributor.authorGumus, Mahmut
dc.contributor.authorBondarenko, Igor
dc.contributor.authorOzguroglu, Mustafa
dc.contributor.authorGogishvili, Miranda
dc.contributor.authorTurk, Haci M.
dc.date.accessioned2024-06-12T11:24:06Z
dc.date.available2024-06-12T11:24:06Z
dc.date.issued2021
dc.departmentTrakya Üniversitesien_US
dc.description.abstractBackground 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. Copyright (C) 2021 Elsevier Ltd. All rights reserved.en_US
dc.description.sponsorshipRegeneron Pharmaceuticals; Sanofien_US
dc.description.sponsorshipRegeneron Pharmaceuticals and Sanofi.en_US
dc.identifier.endpage604en_US
dc.identifier.issn0140-6736
dc.identifier.issn1474-547X
dc.identifier.issue10274en_US
dc.identifier.pmid33581821en_US
dc.identifier.scopus2-s2.0-85100655698en_US
dc.identifier.scopusqualityQ1en_US
dc.identifier.startpage592en_US
dc.identifier.urihttps://hdl.handle.net/20.500.14551/26805
dc.identifier.volume397en_US
dc.identifier.wosWOS:000620934000024en_US
dc.identifier.wosqualityQ1en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherElsevier Science Incen_US
dc.relation.ispartofLanceten_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/closedAccessen_US
dc.subject[No Keywords]en_US
dc.titleCemiplimab 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 trialen_US
dc.typeArticleen_US

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