2026-04-17T16:08:37Zhttps://recercat.cat/oai/request
oai:recercat.cat:2445/2249002026-04-07T22:32:07Zcom_2072_1057col_2072_478916col_2072_478917
RECERCAT author Chul Cho, Byoung author Seok Lee, Jong author Wu, Yi Long author Cicin, Irfan author Cobo Dols, Manuel author Ahn, Myung Ju author Cuppens, Kristof author Veillon, Rémi author Nadal, Ernest author Mourao Dias, Josiane author Martin, Claudio author Reck, Martin author Garon, Edward B. author Felip, Enriqueta author Paz Ares, Luis author Mornex, Francoise author Vokes, Everett E. author Adjei, Alex A. author Robinson, Clifford author Sato, Masashi author Vugmeyster, Yulia author Machl, Andreas author Audhuy, Francois author Chaudhary, Surendra Pal author Barlesi, Fabrice 2025-12-15T09:35:58Z2025-12-15T09:35:58Z2023-08-182025-12-05T09:32:41Z 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/). cc-by (c) International Association for the Study of Lung Cancer, 2023 https://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess Farmacologia respiratòria Assaigs clínics Medicaments antineoplàstics Pulmonary pharmacology Clinical trials Antineoplastic agents Bintrafusp Alfa Versus Pembrolizumab in Patients With Treatment-Naive, Programmed Death-Ligand 1–High Advanced NSCLC: A Randomized, Open-Label, Phase 3 Trial info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion