In a span of a few months, results have been reported from three randomized controlled trials evaluating the benefit of combining immune checkpoint inhibitors (ICIs) with intravesical bacillus Calmette-Guérin (BCG) for BCG-naïve, high-risk non–muscle-invasive bladder cancer (HR-NMIBC). This group constitutes one of the broadest segments of the bladder cancer population, and there is a major unmet need to improve the efficacy of BCG while limiting additive toxicity. The POTOMAC trial revealed a significant difference in event-free survival (EFS) in favor of durvalumab plus BCG induction and maintenance (I + M) in comparison to BCG I + M alone (81.8% vs 77.4% 3-yr EFS) [1].
European Urology published a clinical update in Research Highlights on 19 Jan 2026.
The item focuses on Re: Maria De Santis, Joan Palou Redorta, Hiroyuki Nishiyama, et al.
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;406:2221–34.
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