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

作者：Thomas Powles, Michiel S. van der Heijden, Y. Loriot, Jens Bedke, Begoña P. Valderrama, Ganesh R. Iyer, Eiji Kikuchi, Jean Hoffman‐Censits, Christof Vulsteke, A. Drakaki, S. Rausch, Waddah Arafat, Se Hoon Park, Umang Swami, J.-R. Li, I. Duran, Seema Rao Gorla, Blanca Homet Moreno, Xin Yu, Yingdong Lu, Shilpa Gupta · 发表于：Annals of Oncology · 年份：2025 · DOI：10.1016/j.annonc.2025.05.536 · 被引用次数：68 · 研究领域：Bladder and Urothelial Cancer Treatments、Cancer Immunotherapy and Biomarkers、Esophageal Cancer Research and Treatment

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.