For nearly five decades, intravesical Bacillus Calmette-Guérin (BCG) has remained the cornerstone adjuvant therapy for patients with high-risk non–muscle-invasive bladder cancer (NMIBC). In this context, the phase 3 POTOMAC trial reported by de Santis and colleagues [1] represents an important attempt to enhance outcomes in BCG-naïve high-risk NMIBC by combining immune checkpoint inhibition with standard intravesical BCG therapy. Addition of durvalumab to BCG induction and maintenance met the primary endpoint, with a statistically significant improvement in disease-free survival (DFS) observed in comparison to BCG induction plus maintenance alone (hazard ratio [HR] 0.68, 95% confidence interval [CI] 0.50–0.93) [1].
European Urology published a clinical update in Research Highlights on 04 Feb 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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