JAVELIN Bladder 100 — Avelumab First-Line Maintenance Plus Best Supportive Care Versus Best Supportive Care Alone in Advanced Urothelial Carcinoma

Phase 3 · 2020 · Urothelial Carcinoma, Bladder Cancer

Design

Open-label randomized trial of avelumab maintenance plus best supportive care vs best supportive care alone, started in patients without progression after 4–6 cycles of first-line platinum chemotherapy.

Population

Advanced or metastatic urothelial carcinoma that had not progressed after first-line platinum-based chemotherapy.

Primary Endpoint

overall survival (OS)

Key Result

Mature analysis (median follow-up ~38 mo): median OS 23.8 vs 15.0 mo (HR 0.76, P=0.0036); median PFS 5.5 vs 2.1 mo (HR 0.54); 2-yr OS 49.8% vs 38.4%.

Guideline Impact

NCCN category 1 first-line maintenance for advanced urothelial carcinoma after platinum chemotherapy