Multinational phase 3 trial of first-line enfortumab vedotin plus pembrolizumab for advanced urothelial carcinoma

Standard treatment for previously untreated locally advanced or metastatic urothelial carcinoma is platinum-based chemotherapy. The multinational phase 3 EV-302 trial evaluated the combination of the antibody-drug conjugate enfortumab vedotin (EV) and the anti-PD-1 antibody pembrolizumab as first-line treatment for advanced urothelial carcinoma. Patients were randomized 1:1 to EV plus pembrolizumab or to platinum-based chemotherapy. Median progression-free survival was 12.5 months with EV-pembrolizumab versus 6.3 months with chemotherapy (HR 0.45; p<0.001) and median overall survival was 31.5 months versus 16.1 months (HR 0.47; pxtagstartz0.001). Treatment-related adverse events of grade 3 or higher occurred in 55.9% of the patients in the EV-pembrolizumab group and in 69.5% of the patients in the chemotherapy group. The authors conclude that among patients with untreated locally advanced or metastatic urothelial carcinoma, EV plus pembrolizumab resulted in significantly better outcomes than chemotherapy.