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Title: | Bintrafusp Alfa Versus Pembrolizumab in Patients With Treatment-Naive, Programmed Death-Ligand 1-High Advanced NSCLC: A Randomized, Open-Label, Phase 3 Trial | Authors: | Cho, Byoung Chul Lee, Jong Seok Wu , Yi-Long Cicin, Irfan Dols, Manuel Cobo Ahn, Myung-Ju CUPPENS, Kristof Veillon, Remi Nadal, Ernest Dias, Josiane Mourao Martin, Claudio Reck, Martin Garon, Edward B. Felip, Enriqueta Paz-Ares, Luis Mornex, Francoise Vokes, Everett E. Adjei, Alex A. Robinson, Clifford Sato, Masashi Vugmeyster, Yulia Machl, Andreas Audhuy, Francois Chaudhary, Surendra Barlesi, Fabrice |
Issue Date: | 2023 | Publisher: | ELSEVIER SCIENCE INC | Source: | Journal of Thoracic Oncology, 18 (12) , p. 1731 -1742 | Abstract: | Introduction: 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/). | Notes: | Barlesi, F (corresponding author), Hop St Marguerite, Federat Malad Respiratoires, Serv Oncol Thorac, 270,Bd St Marguerite, F-13274 Marseille 09, France. fabrice.barlesi@gustaveroussy.fr |
Keywords: | Bintrafusp alfa;Phase 3;NSCLC;PD-L1 | Document URI: | http://hdl.handle.net/1942/42102 | ISSN: | 1556-0864 | e-ISSN: | 1556-1380 | DOI: | 10.1016/j.jtho.2023.08.018 | ISI #: | 001129725400001 | Rights: | 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/). | Category: | A1 | Type: | Journal Contribution |
Appears in Collections: | Research publications |
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