EV-302 / KEYNOTE-A39
Enfortumab Vedotin + Pembrolizumab in Advanced Urothelial Carcinoma
Patient / Population Intervention / Exposure Comparison Outcome
In 886 patients with untreated advanced urothelial carcinoma, enfortumab vedotin + pembrolizumab improved progression-free and overall survival compared with platinum-based chemotherapy.
N
886
Design
Open-label RCT
Endpoint
PFS and OS (co-primary)
Relevance
2
ResultOS 31.5 vs 16.1 months (HR 0.47). PFS HR 0.45; ORR 67.7% vs 44.4%.
Powles T, et al. N Engl J Med. 2024;390(10):875-888. 10.1056/NEJMoa2312117
Discussion & critique
Displaced platinum-based chemotherapy as first-line standard in advanced urothelial cancer — the largest OS gain ever shown in this setting.