Durvalumab in NMIBC Care / NMIBC 06/08/2026

Defining High-Risk Non–Muscle-Invasive Bladder Cancer and the Limits of BCG Alone

Key Points

  • Non–muscle-invasive bladder cancer (NMIBC) is stratified into low-, intermediate-, and high-risk disease based on stage, grade, and carcinoma in situ (CIS) presence.
  • High-risk disease includes T1 lesions, CIS, and high-grade papillary tumors, all of which carry a significant risk of progression.
  • BCG induction plus maintenance has been the standard of care for decades but remains insufficient for many patients.
  • High-risk NMIBC can still progress to muscle-invasive disease in up to 25% to 50% of very high-risk cases.

At a Clinical Insights discussion coinciding with the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, Oncology Brothers podcast cohosts Rahul Gosain, MD, MBA, of Wilmot Cancer Institute, and Rohit Gosain, MD, of Roswell Park Comprehensive Cancer Center, were joined by Shilpa Gupta, MD, of Cleveland Clinic; Amit Patel, MD, of Duly Health and Care; and Neal Shore, MD, FACS, of the Carolina Urologic Research Center, to consider the evolving management of high-risk NMIBC. The conversation opened in the context of the recent phase 3 POTOMAC trial, which supported adding durvalumab to BCG in a setting historically managed with BCG alone.

Dr. Shore provided a structured overview of NMIBC risk categories, emphasizing the distinction between low-, intermediate-, and high-risk disease. High-risk disease includes high-grade papillary tumors, CIS, and T1 lesions involving the lamina propria, all of which carry a meaningful risk of progression to muscle-invasive bladder cancer. Although low-risk disease may be managed conservatively, high-risk NMIBC has long required a more aggressive approach centered on BCG induction and maintenance.

Dr. Patel highlighted that, despite decades of BCG use, recurrence rates in high-risk populations remain substantial, reaching up to approximately 70% within 5 years in some cohorts, with progression risks as high as 25% to 50% in patients with very high-risk features such as extensive T1 disease or CIS. These limitations have driven ongoing efforts to intensify early treatment strategies and integrate systemic immunotherapy earlier in the disease course.

The segment concluded with framing of the POTOMAC study as a pivotal step forward, laying the groundwork for deeper exploration of trial design, outcomes, and practice implications in subsequent segments.