NIAGARA — Perioperative Durvalumab With Neoadjuvant Chemotherapy in Cisplatin-Eligible Muscle-Invasive Bladder Cancer

Phase 3 · 2024 · Bladder Cancer, Urothelial Carcinoma

Design

Randomized open-label to neoadjuvant durvalumab plus gemcitabine-cisplatin followed by radical cystectomy and adjuvant durvalumab, vs neoadjuvant gemcitabine-cisplatin and cystectomy alone.

Population

Cisplatin-eligible muscle-invasive bladder cancer (cT2-T4aN0/N1M0) planned for radical cystectomy.

Primary Endpoint

event-free survival (EFS) and overall survival (OS)

Key Result

EFS HR 0.68; 24-month OS 82.2% vs 75.2% (OS HR 0.75).

Guideline Impact

Supported perioperative durvalumab plus neoadjuvant chemotherapy for cisplatin-eligible muscle-invasive bladder cancer