Assessment of Efficacy and Safety of Durvalumab Plus BCG Compared to the Standard Therapy With BCG in Non-muscle Invasive Bladder Cancer

Summary

This is a randomized, open-label, multi-center, global, phase III study to determine the efficacy and safety of Durvalumab + BCG combination therapy in the treatment of patients with non-muscle-invasive bladder cancer

Timeline

Start

2018-05-14

Primary completion

2025-04-03

Completion

2028-10-03

Outcome

Met primary endpoint

paper hazard ratio 0·68 [95% CI 0·50-0·93]; log-rank p=0·015 PMID 41115436 ↗

paper showed a statistically significant and clinically meaningful improvement in disease-free survival versus BCG induction and maintenance alone. PMID 41115436 ↗

release “met the primary endpoint of disease-free survival for patients with high-risk non-muscle-invasive bladder cancer in the POTOMAC Phase III trial.” astrazeneca.com ↗

Publications

• De Santis M, Palou Redorta J, Nishiyama H, Krawczynski M, Seyitkuliev A, Novikov A, Guerrero-Ramos F, Zukov R, Kato M, Kawahara T, Goeman L, Puente J, Hellmis E, Powles T, Radziszewski P, Gust KM, Vasey P, Bigot P, Fradet Y, Hunting J, Armstrong J, Boulos S, Hois S, Shore ND; POTOMAC Investigators. Durvalumab in combination with BCG for BCG-naive, high-risk, non-muscle-invasive bladder cancer (POTOMAC): final analysis of a randomised, open-label, phase 3 trial. Lancet. 2025 Nov 8;406(10516):2221-2234. doi: 10.1016/S0140-6736(25)01897-5. Epub 2025 Oct 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bacillus Calmette-Guérin	Vaccine	—	Other
Subject	Durvalumab	Monoclonal antibody	—	Intravenous

Indications