Annals of oncology : official journal of the European Society for Medical Oncology · 2025
A randomised phase III study of bevacizumab and carboplatin-pemetrexed chemotherapy with or without atezolizumab as first-line treatment for advanced pleural mesothelioma: results of the ETOP 13-18 BEAT-meso trial.
СтатьяКлиническое исследование III фазыРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Felip E, Popat S, Dafni U, Ribi K, Pope A, Cedres S, Shah R, de Marinis F, Cove Smith L, Bernabé R, Früh M, Nackaerts K, Greillier L, Scherz A, Massuti B, Nadal E, Vila Martinez L, Talbot T, Roschitzki-Voser H, Dimopoulou G, Schär S, Ruepp B, Savic S, Peters S, Stahel R, ETOP 13-18 BEAT-meso Collaborators
Аннотация
BACKGROUND: The currently approved first-line treatments for diffuse pleural mesothelioma (DPM) are ipilimumab-nivolumab or platinum-pemetrexed. The addition of bevacizumab to chemotherapy improves overall survival (OS). While single-agent immunotherapy or chemotherapy-immunotherapy combinations are superior to chemotherapy monotherapy, there is a potential for synergistic triple combination of chemotherapy, bevacizumab, and immunotherapy.
PATIENTS AND METHODS: BEAT-meso is an international, open-label, 1 : 1 randomised, phase III trial, with stratification factors histology and stage aiming to determine the efficacy and safety of adding atezolizumab [1200 mg, 3-week cycle (q3w) until progression] to bevacizumab (15 mg/kg, q3w until progression) and standard chemotherapy (4-6 cycles of carboplatin area under the curve with pemetrexed 500 mg/m2, q3w; ABC versus BC) as first-line treatment for advanced DPM. The primary endpoint is OS in all randomised patients, aiming for a relative benefit of 29% [hazard ratio (HR) 0.708]. Secondary endpoints include progression-free survival (PFS), adverse events (AEs), and symptom-specific and global quality of life (QoL).
RESULTS: Between 30 April 2019 and 7 March 2022, 400 patients were randomised, 200 per arm. Sixty-five percent had an Eastern Cooperative Oncology Group (ECOG) performance status of 1 and 78% had epithelioid histology. At a median follow-up of 35 months (data cut-off 1 September 2023), the median OS was 20.5 months for ABC versus 18.1 months for BC [HR 0.84, 95% confidence interval (CI) 0.66-1.06, P = 0.14]. Median PFS was significantly longer for ABC than for BC (9.2 versus 7.6 months) (HR 0.72, 95% CI 0.59-0.89, P = 0.0021). Histology showed significant treatment interaction for both PFS and OS, with an OS HR of 0.51 (95% CI 0.32-0.80) for non-epithelioid and 1.01 (95% CI 0.77-1.32) for epithelioid (interaction P = 0.012). Grade ≥3 treatment-related AEs were reported in 55% of patients in ABC and 47% in BC; QoL was maintained with ABC with no clinically meaningful differences from BC.
CONCLUSIONS: The significant benefit in median PFS for ABC found in this study translated into a numerical but not significant increase in median OS. Thus, the primary endpoint was not met. In the pre-specified analysis by histology, superior OS and PFS were found for ABC in non-epithelioid cases.
PATIENTS AND METHODS: BEAT-meso is an international, open-label, 1 : 1 randomised, phase III trial, with stratification factors histology and stage aiming to determine the efficacy and safety of adding atezolizumab [1200 mg, 3-week cycle (q3w) until progression] to bevacizumab (15 mg/kg, q3w until progression) and standard chemotherapy (4-6 cycles of carboplatin area under the curve with pemetrexed 500 mg/m2, q3w; ABC versus BC) as first-line treatment for advanced DPM. The primary endpoint is OS in all randomised patients, aiming for a relative benefit of 29% [hazard ratio (HR) 0.708]. Secondary endpoints include progression-free survival (PFS), adverse events (AEs), and symptom-specific and global quality of life (QoL).
RESULTS: Between 30 April 2019 and 7 March 2022, 400 patients were randomised, 200 per arm. Sixty-five percent had an Eastern Cooperative Oncology Group (ECOG) performance status of 1 and 78% had epithelioid histology. At a median follow-up of 35 months (data cut-off 1 September 2023), the median OS was 20.5 months for ABC versus 18.1 months for BC [HR 0.84, 95% confidence interval (CI) 0.66-1.06, P = 0.14]. Median PFS was significantly longer for ABC than for BC (9.2 versus 7.6 months) (HR 0.72, 95% CI 0.59-0.89, P = 0.0021). Histology showed significant treatment interaction for both PFS and OS, with an OS HR of 0.51 (95% CI 0.32-0.80) for non-epithelioid and 1.01 (95% CI 0.77-1.32) for epithelioid (interaction P = 0.012). Grade ≥3 treatment-related AEs were reported in 55% of patients in ABC and 47% in BC; QoL was maintained with ABC with no clinically meaningful differences from BC.
CONCLUSIONS: The significant benefit in median PFS for ABC found in this study translated into a numerical but not significant increase in median OS. Thus, the primary endpoint was not met. In the pre-specified analysis by histology, superior OS and PFS were found for ABC in non-epithelioid cases.