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oai:recercat.cat:2445/2249002026-04-07T22:32:07Zcom_2072_1057col_2072_478916col_2072_478917

Bintrafusp Alfa Versus Pembrolizumab in Patients With Treatment-Naive, Programmed Death-Ligand 1–High Advanced NSCLC: A Randomized, Open-Label, Phase 3 Trial Chul Cho, Byoung Seok Lee, Jong Wu, Yi Long Cicin, Irfan Cobo Dols, Manuel Ahn, Myung Ju Cuppens, Kristof Veillon, Rémi Nadal, Ernest Mourao Dias, Josiane 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 Pal Barlesi, Fabrice Farmacologia respiratòria Assaigs clínics Medicaments antineoplàstics Pulmonary pharmacology Clinical trials Antineoplastic agents 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/). 2025-12-15T09:35:58Z 2025-12-15T09:35:58Z 2023-08-18 2025-12-05T09:32:41Z info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion 1556-0864 https://hdl.handle.net/2445/224900 37597750 eng Reproducció del document publicat a: https://doi.org/10.1016/j.jtho.2023.08.018 Journal of Thoracic Oncology, 2023, vol. 18, num. 12, 1731-1742 https://doi.org/10.1016/j.jtho.2023.08.018 cc-by (c) International Association for the Study of Lung Cancer, 2023 https://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess 12 p. application/pdf Elsevier BV Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))