Lung cancer (Amsterdam, Netherlands) · 2025
Efficacy and safety of bintrafusp alfa evaluated in a phase II single-arm clinical trial in previously treated advanced pleural mesothelioma.
СтатьяКлиническое исследование II фазыМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Nadal Ernest, Martín-Martorell Paloma, Benítez Jose Carlos, Sala Maria Ángeles, Cedrés Susana, Álvarez Carlos, Dómine Manuel, Sais Elia, Saigí Maria, López Rafael, Vilà Laia, Massutí Bartomeu, García-Campelo Rosario, Mesas-Ruiz Andres, Insa Amelia, Plans-Marín Sílvia, Hijazo-Pechero Sara, Muñoz-Pinedo Cristina, Brenes Jesús, Provencio Mariano, Spanish Lung Cancer Group
Аннотация
OBJECTIVES: We aimed to evaluate the efficacy (progression-free survival [PFS]) of bintrafusp alfa in patients with pleural mesothelioma (PM) who had progressed to platinum-based chemotherapy and had not previously received immunotherapy. We also assessed overall survival [OS], objective response rate [ORR], and safety and tolerability.
MATERIALS AND METHODS: This open-label, non-randomised, multicentre, phase II, single-arm clinical trial was carried out by the Spanish Lung Cancer Group between October 2021 and March 2023 in 15 Spanish hospitals. We included patients ≥ 18 years old, with an ECOG PS of 0 or 1, with a histologically confirmed unresectable or metastatic PM, and with a life expectancy of at least three months.
RESULTS: 46 patients were included in the analysis. Most patients were men (78.3 %), the mean age was 70.0 years (SD, 9.5), and most presented epithelioid PM (84.8 %). The median PFS was 1.9 months (95 % CI, 1.7-3.2 months), the median duration of bintrafusp alfa response was 3.8 months, and the ORR was 6.5 % (95 % CI, 2.1-18.8 %). The median OS was 11.9 months (95 % CI, 5.8-15.7 months). Grade 3 or higher adverse events were observed in 34.8 % of patients and no grade 5 adverse event was reported.
CONCLUSION: Bintrafusp alfa did not reach the expected efficacy in patients with advanced PM. We did not identify new safety signals with bintrafusp alfa, and no case of bleeding was reported. Our study suggested that bintrafusp alfa has limited efficacy in PM, as reported in other solid tumours.
MATERIALS AND METHODS: This open-label, non-randomised, multicentre, phase II, single-arm clinical trial was carried out by the Spanish Lung Cancer Group between October 2021 and March 2023 in 15 Spanish hospitals. We included patients ≥ 18 years old, with an ECOG PS of 0 or 1, with a histologically confirmed unresectable or metastatic PM, and with a life expectancy of at least three months.
RESULTS: 46 patients were included in the analysis. Most patients were men (78.3 %), the mean age was 70.0 years (SD, 9.5), and most presented epithelioid PM (84.8 %). The median PFS was 1.9 months (95 % CI, 1.7-3.2 months), the median duration of bintrafusp alfa response was 3.8 months, and the ORR was 6.5 % (95 % CI, 2.1-18.8 %). The median OS was 11.9 months (95 % CI, 5.8-15.7 months). Grade 3 or higher adverse events were observed in 34.8 % of patients and no grade 5 adverse event was reported.
CONCLUSION: Bintrafusp alfa did not reach the expected efficacy in patients with advanced PM. We did not identify new safety signals with bintrafusp alfa, and no case of bleeding was reported. Our study suggested that bintrafusp alfa has limited efficacy in PM, as reported in other solid tumours.