High-Risk BCG-Naive NMIBC: Where Treatment Falls Short Today

Welcome back to another Urology Times Special Report series. In this episode, Neal D. Shore, MD, FACS discusses unmet needs in high-risk, BCG-naive non–muscle invasive bladder cancer (NMIBC) with Chandler Park, MD.

Shore opens this special report by welcoming Park, a medical oncologist who also sees a high volume of bladder cancer patients in community practice, and notes he presented the POTOMAC (NCT03528694) trial data at the 2026 American Urological Association (AUA) Annual Meeting. Park says he is glad the durvalumab (Imfinzi)-BCG combination earned FDA approval because it gives urologists and patients a genuine opportunity to discuss the best individualized treatment. He recalls a related conversation the two had at the 2025 European Society for Medical Oncology Congress, when the original POTOMAC data first emerged from a presentation by Maria De Santis, MD, and notes additional data has since been presented at this year's AUA meeting in Washington, DC. Park adds that a multidisciplinary approach across urology, medical oncology, radiation oncology, nuclear medicine, and pathology has become the standard across cancer care.

Asked about the biggest unmet need in treating high-risk, BCG-naive NMIBC, Park answers first, describing how he works closely with First Urology, a 40-plus-physician urology group in Louisville, seeing patients together in a multidisciplinary tumor board. He explains that early recurrence is associated with worse outcomes, and although there are several single-arm-study treatment options for BCG-unresponsive disease, the combination of durvalumab plus BCG offers durable disease control that avoids cystectomy in the BCG-naïve setting.

Turning the question back to Shore, he explains that outcomes have largely stagnated since the original induction-and-maintenance BCG protocols were established and that many patients with high-risk disease who fail BCG do not want cystectomy. Shore closes by noting that FDA approval now enables genuine shared decision-making, with durvalumab available as an added option.

In the next episode, "Inside the POTOMAC Trial: Durvalumab Plus BCG for High-Risk NMIBC," Park praises Shore's role in the trial, then presses him on how POTOMAC's design and primary DFS results translate into everyday sequencing decisions after transurethral resection of the bladder tumor.