EV-302 — Enfortumab Vedotin Plus Pembrolizumab Versus Chemotherapy Alone in Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma

Phase 3 · 2023 · Urothelial Carcinoma, Bladder Cancer

Design

Randomized trial of enfortumab vedotin plus pembrolizumab vs. platinum-based chemotherapy as first-line therapy.

Population

Previously untreated locally advanced/metastatic urothelial carcinoma, cisplatin-eligible or -ineligible.

Primary Endpoint

overall survival (OS) and progression-free survival (PFS)

Key Result

Median OS 31.5 vs 16.1 mo (HR 0.47); median PFS 12.5 vs 6.3 mo (HR 0.45); ORR 67.7% vs 44.4%.

Guideline Impact

NCCN category 1 preferred first-line for metastatic urothelial carcinoma