Bintrafusp Alfa Versus Pembrolizumab in Patients With Treatment-Naive, Programmed Death-Ligand 1-High Advanced NSCLC: A Randomized, Open-Label, Phase 3 Trial

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dc.authoridCuppens, Kristof/0000-0002-8153-0008
dc.authoridCho, Byoung Chul/0000-0002-5562-270X
dc.authorwosidCuppens, Kristof/ABB-2224-2021
dc.contributor.authorCho, Byoung Chul
dc.contributor.authorLee, Jong Seok
dc.contributor.authorWu, Yi-Long
dc.contributor.authorCicin, Irfan
dc.contributor.authorDols, Manuel Cobo
dc.contributor.authorAhn, Myung-Ju
dc.contributor.authorCuppens, Kristof
dc.date.accessioned2024-06-12T10:54:36Z
dc.date.available2024-06-12T10:54:36Z
dc.date.issued2023
dc.departmentTrakya Üniversitesien_US
dc.description.abstractIntroduction: Bintrafusp alfa, a first-in-class bifunctional fusion protein composed of the extracellular domain of TGF-bRII (a TGF-b trap) fused to a human immuno-globulin G1 monoclonal antibody blocking programmed death-ligand 1 (PD-L1), has exhibited clinical activity in a phase 1 expansion cohort of patients with PD-L1-high advanced NSCLC. Methods: This adaptive phase 3 trial (NCT03631706) compared the efficacy and safety of bintrafusp alfa versus pembrolizumab as first-line treatment in patients with PD-L1-high advanced NSCLC. Primary end points were progression-free survival according to Response Evaluation Criteria in Solid Tumors version 1.1 per independent review committee and overall survival. Results: Patients (N = 304) were randomized one-to-one to receive either bintrafusp alfa or pembrolizumab (n = 152 each). The median follow-up was 14.3 months (95% confidence interval [CI]: 13.1-16.0 mo) for bintrafusp alfa and 14.5 months (95% CI: 13.1-15.9 mo) for pem-brolizumab. Progression-free survival by independent re-view committee was not significantly different between bintrafusp alfa and pembrolizumab arms (median = 7.0 mo [95% CI: 4.2 mo-not reached (NR)] versus 11.1 mo [95% CI: 8.1 mo-NR]; hazard ratio = 1.232 [95% CI: 0.885- 1.714]). The median overall survival was 21.1 months (95% CI: 21.1 mo-NR) for bintrafusp alfa and 22.1 months (95% CI: 20.4 mo-NR) for pembrolizumab (hazard ratio = 1.201 [95% CI: 0.796-1.811]). Treatment-related adverse events were higher with bintrafusp alfa versus pembrolizumab; grade 3-4 treatment-related adverse events occurred in 42.4% versus 13.2% of patients, respectively. The study was discontinued at an interim analysis as it was unlikely to meet the primary end point. Conclusions: First-line treatment with bintrafusp alfa did not exhibit superior efficacy compared with pembrolizumab in patients with PD-L1-high, advanced NSCLC.(c) 2023 International Association for the Study of Lung Cancer. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons. org/licenses/by/4.0/).en_US
dc.description.sponsorshipMerck KGaA, Darmstadt, Germanyen_US
dc.description.sponsorshipThe trial was sponsored by the healthcare business of Merck KGaA, Darmstadt, Germany (CrossRef Funder identification: 10.13039/100009945) and was previously part of an alliance between the healthcare business of Merck KGaA, Darmstadt, Germany, and GlaxoSmithKline. The healthcare business of Merck KGaA, Darmstadt, Germany provided the trial drugs. The investigators worked with the healthcare business of Merck KGaA, Darmstadt, Germany on the trial design, collection and analysis of data, and interpretation of results. The authors thank the patients and their families, investigators, co-investigators, and the study teams at each of the participating centers and the healthcare business of Merck KGaA, Darmstadt, Germany. The medical writing support was provided by Joyce Lee, PhD, ClinicalThinking, which was funded by the healthcare business of Merck KGaA, Darmstadt, Germany, and was previously part of an alliance between the healthcare business of Merck KGaA, Darmstadt, Germany, and GlaxoSmithKline in accordance with Good Publication Practice (GPP3) guidelines (http:// www.ismpp.org/gpp3) .en_US
dc.identifier.doi10.1016/j.jtho.2023.08.018
dc.identifier.endpage1742en_US
dc.identifier.issn1556-0864
dc.identifier.issn1556-1380
dc.identifier.issue12en_US
dc.identifier.pmid37597750en_US
dc.identifier.scopus2-s2.0-85171841011en_US
dc.identifier.scopusqualityQ1en_US
dc.identifier.startpage1731en_US
dc.identifier.urihttps://doi.org/10.1016/j.jtho.2023.08.018
dc.identifier.urihttps://hdl.handle.net/20.500.14551/19089
dc.identifier.volume18en_US
dc.identifier.wosWOS:001129725400001en_US
dc.identifier.wosqualityN/Aen_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherElsevier Science Incen_US
dc.relation.ispartofJournal Of Thoracic Oncologyen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectBintrafusp Alfaen_US
dc.subjectPhase 3en_US
dc.subjectNSCLCen_US
dc.subjectPD-L1en_US
dc.subjectCell Lung-Canceren_US
dc.subjectTgf-Betaen_US
dc.subjectPd-L1en_US
dc.titleBintrafusp Alfa Versus Pembrolizumab in Patients With Treatment-Naive, Programmed Death-Ligand 1-High Advanced NSCLC: A Randomized, Open-Label, Phase 3 Trialen_US
dc.typeArticleen_US

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