Annals of oncology : official journal of the European Society for Medical Oncology · 2025
Enfortumab vedotin plus pembrolizumab in untreated locally advanced or metastatic urothelial carcinoma: 2.5-year median follow-up of the phase III EV-302/KEYNOTE-A39 trial.
СтатьяКлиническое исследование III фазыРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Powles T B, Van der Heijden M S, Loriot Y, Bedke J, Valderrama B P, Iyer G, Kikuchi E, Hoffman-Censits J, Vulsteke C, Drakaki A, Rausch S, Arafat W, Park S H, Swami U, Li J-R, Duran I, Gorla S, Homet Moreno B, Yu X, Lu Y-T, Gupta S
Аннотация
BACKGROUND: At the primary analysis of the EV-302 trial, enfortumab vedotin plus pembrolizumab (EV+P) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) and overall survival (OS) compared with chemotherapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC).
PATIENTS AND METHODS: We present an updated analysis of efficacy and safety in the overall population, with a median follow-up of 2.5 years, providing an additional year of follow-up since the primary analysis.
RESULTS: The median PFS by blinded independent central review was 12.5 months [95% confidence interval (CI) 10.4-16.6 months] for the EV+P arm and 6.3 months (95% CI 6.2-6.5 months) for the chemotherapy arm [hazard ratio (HR) 0.48, 95% CI 0.41-0.57]. The median OS was 33.8 months (95% CI 26.1-39.3 months) for the EV+P arm and 15.9 months (95% CI 13.6-18.3 months) for the chemotherapy arm (HR 0.51, 95% CI 0.43-0.61). Safety data with an additional year of follow-up were consistent with those of the primary analysis.
CONCLUSION: The continued survival benefit with EV+P compared with chemotherapy in this updated analysis reinforces EV+P as the standard of care for the first-line treatment of patients with la/mUC.
PATIENTS AND METHODS: We present an updated analysis of efficacy and safety in the overall population, with a median follow-up of 2.5 years, providing an additional year of follow-up since the primary analysis.
RESULTS: The median PFS by blinded independent central review was 12.5 months [95% confidence interval (CI) 10.4-16.6 months] for the EV+P arm and 6.3 months (95% CI 6.2-6.5 months) for the chemotherapy arm [hazard ratio (HR) 0.48, 95% CI 0.41-0.57]. The median OS was 33.8 months (95% CI 26.1-39.3 months) for the EV+P arm and 15.9 months (95% CI 13.6-18.3 months) for the chemotherapy arm (HR 0.51, 95% CI 0.43-0.61). Safety data with an additional year of follow-up were consistent with those of the primary analysis.
CONCLUSION: The continued survival benefit with EV+P compared with chemotherapy in this updated analysis reinforces EV+P as the standard of care for the first-line treatment of patients with la/mUC.