EV-304 / KEYNOTE-B15 — Perioperative enfortumab vedotin plus pembrolizumab versus neoadjuvant chemotherapy in cisplatin-eligible muscle-invasive bladder cancer (EV-304)

Phase 3 · Bladder Cancer, Urothelial Carcinoma

Population

Cisplatin-eligible muscle-invasive bladder cancer scheduled for radical cystectomy.

Primary Endpoint

Event-free survival and overall survival

Rationale

Enfortumab vedotin plus pembrolizumab transformed first-line metastatic urothelial cancer in EV-302. EV-304 tests whether moving that regimen into the curative perioperative setting can beat the long-standing neoadjuvant cisplatin chemotherapy standard.

What It Could Change

Could make perioperative enfortumab vedotin plus pembrolizumab the new standard for cisplatin-eligible muscle-invasive bladder cancer, displacing neoadjuvant chemotherapy.