Durvalumab and BCG Approved for Treating High-Risk NMIBC
Las Vegas, Nevada (UroToday.com) -- In a significant development for the urologic oncology community, the U.S. Food and Drug Administration (FDA) has approved durvalumab (Imfinzi) in combination with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).
The approval provides a new therapeutic avenue for patients whose disease has not yet been treated with BCG and carries a high risk of progression.
The POTOMAC trial: Efficacy and study design
The regulatory decision was supported by results from the POTOMAC study (NCT03528694), a randomized, open-label, multicenter clinical trial. The study enrolled 1,018 patients with high-risk NMIBC following a transurethral resection of the bladder tumor (TURBT). To qualify as "high-risk," patients had to present with at least one of the following clinical features: a T1 tumor, grade 3/high-grade tumor, carcinoma in situ (CIS), or multiple, recurrent, and large tumors.
Participants were randomized 1:1:1 into three arms: durvalumab plus BCG induction and maintenance, BCG induction and maintenance alone, or an additional investigational combination. The primary efficacy endpoint was investigator-assessed disease-free survival (DFS), which the study defined as the interval between randomization and the first instance of NMIBC recurrence, persistent CIS, progression to muscle-invasive disease, metastasis, or death.
Data from the trial demonstrated a statistically significant improvement in DFS for patients receiving the durvalumab and BCG combination compared to those receiving BCG alone. The hazard ratio was 0.68 (95% CI: 0.50, 0.93; p=0.0154), representing a 32% reduction in the risk of recurrence or death. Notably, the median DFS was not reached in either treatment arm at the time of the analysis.
Source: Oncology Nursing News. (2026). Durvalumab and BCG Approved for Treating High-Risk NMIBC [Press release]. https://www.oncnursingnews.com/view/fda-approves-durvalumab-and-bcg-for-high-risk-nmibc.