Durvalumab in NMIBC Care / NMIBC 06/09/2026

POTOMAC Trial Breakthrough: Durvalumab Plus BCG Shows Improved Recurrence-Free Survival

High-quality professional portrait of a confident woman in business attire, showcasing leadership and expertise in healthcare or corporate settings. Shilpa Gupta, MD Amit Patel, MD A professional male oncologist in a suit smiling against a gray background for cancer treatment and healthcare research. Neal Shore, MD, FACS Smiling man with beard wearing a white shirt, professional headshot, suitable for oncology or cancer research content, emphasizing healthcare and medical expertise. Rahul Gosain, MD, MBA Oncologist smiling in white coat, highlighting cancer research and treatment expertise, with a bow tie, in a bright medical setting. Rohit Gosain, MD

Key Points

  • POTOMAC evaluated durvalumab plus BCG versus standard BCG in high-risk non–muscle-invasive bladder cancer (NMIBC).
  • The combination improved recurrence-free survival (RFS) with a hazard ratio of approximately 0.68.
  • Overall survival data are still immature, but early secondary end points are encouraging.
  • No unexpected safety signals or grade 5 treatment-related adverse events were observed.

At a Clinical Insights discussion coinciding with the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, Rahul Gosain, MD, MBA, of Wilmot Cancer Institute, and Rohit Gosain, MD, of Roswell Park Comprehensive Cancer Center — cohosts of the Oncology Brothers podcast — 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 examine the findings of the phase 3 POTOMAC trial and their potential impact on clinical practice. 

In this portion of the discussion, Dr. Gupta outlined the design and results of the phase 3 POTOMAC trial, which evaluated durvalumab in combination with BCG for patients with high-risk NMIBC. The study enrolled over 1000 patients and compared standard BCG induction plus maintenance against durvalumab combined with BCG, with a third exploratory arm assessing durvalumab with BCG induction alone.

The primary analysis compared durvalumab plus BCG induction and maintenance versus BCG alone, with RFS as the primary end point. The trial demonstrated a clinically meaningful improvement, with a hazard ratio of approximately 0.68 favoring the combination arm, suggesting that early integration of immune checkpoint inhibition may reduce recurrence patterns.

Dr. Gupta emphasized that overall survival data remain immature, but early signals such as cystectomy-free survival were encouraging. Dr. Shore noted that additional analyses presented at major meetings reinforced reductions in high-risk recurrence and BCG-unresponsive disease in patients receiving the combination, without new safety signals or grade 5 treatment-related adverse events.

Dr. Patel further discussed patient selection considerations, emphasizing that in the absence of validated predictive biomarkers, clinicians are likely to prioritize patients with the highest-risk features, including T1 disease with CIS or other adverse pathological characteristics. The group highlighted the importance of multidisciplinary collaboration between urologists and medical oncologists as immunotherapy moves earlier in the disease continuum.