Clinical Summary: 

• Design/Population: Additional analyses from the phase 3 POTOMAC trial evaluated durvalumab plus BCG induction and maintenance compared to BCG alone in BCG-naïve patients with high-risk non-muscle-invasive bladder cancer. 
• Key Outcomes: Durvalumab plus BCG reduced early high-risk disease events and BCG-unresponsive recurrences, delayed time to high-risk recurrence and cystectomy, and improved cystectomy-free survival compared with BCG alone.
• Clinical Relevance: These findings further support the addition of durvalumab to BCG as a potential treatment strategy for patients with high-risk NMIBC.

Updated results from the POTOMAC trial demonstrated that durvalumab plus Bacillus Calmetter-Guerin (BCG) induction and maintenance reduced recurrence-related outcomes among BCG-naïve patients with high-risk non-muscle-invasive bladder cancer.

These results were presented by Neal Shore, MD, Atlantic Urology Clinics, Myrtle Beach, South Carolina, at the 2026 American Urological Association (AUA) Annual Meeting in Washington, District of Columbia.

In this study, 679 patients who underwent complete transurethral resection of bladder were randomized to receive BCG induction and maintenance either alone (n = 340) or with durvalumab (n = 339). The primary end point was the rate of high-risk disease events. Key secondary and exploratory end points included time to cystectomy, time to high-risk disease events, BCG-unresponsive disease, and cystectomy-free survival. 

At analysis, high-risk disease events were reported in 15.63% of patients in the durvalumab plus BCG arm and 20.29% of patients in the BCG arm. The median time to a high-risk event was 14.1 months and 8.3 months, respectively. High-risk events occurring within 1 year of randomization were reported in 45.28% of patients in the durvalumab plus BCG arm and 60.87% of patients in the BCG arm. 

Among patients who experienced disease recurrence, criteria for BCG-unresponsive disease was met by 64.86% of patients in the durvalumab plus BCG arm and 81.48% of patients in the BCG arm. Median time to cystectomy was 19 months in the durvalumab plus BCG arm and 14.1 months in the BCG arm. Cystectomy-free survival favored the durvalumab arm, with a hazard ratio of 0.69. Safety was consistent with prior findings. 

“These data further support [durvalumab plus] BCG [induction and maintenance] as a potential new treatment in this setting,” concluded Dr Shore. 

Source: 

Shore ND, De Santis M, Redorta JP, et al. Durvalumab in combination with Bacillus Calmetter-Guerin induction and maintenance therapy for Bacillus Calmetter-Guerin-naive, high-risk non-muscle-invasive bladder cancer: Expanded efficacy and safety analyses from POTOMAC. J Urol. Published online: May 1, 2026. doi:10.1097/01.JU.0001192572.07890.f8.05