FDA approves durvalumab plus BCG for BCG-naïve, high-risk NMIBC

On May 28, 2026, the FDA approved durvalumab (Imfinzi) in combination with BCG for the treatment of adult patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).¹

“The durvalumab plus BCG regimen is the first new therapy approved in over 30 years for patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer,” said Neal Shore, MD, FACS, Director of START Carolinas / Head of the Carolina Urologic Research Center and co-principal investigator in the POTOMAC trial, in a news release on the approval.² “Unfortunately, many of these patients experience disease recurrence requiring repeated surgical procedures, as well as disease progression resulting in surgical removal of their bladder. The POTOMAC trial demonstrates that the durvalumab with BCG induction and maintenance regimen reduces the risk of disease recurrence, progression or death for patients by almost a third compared to BCG alone, heralding a marked advancement for patients with high-risk non-muscle-invasive bladder cancer.”

According to the agency, the recommended dose for durvalumab in patients with a body weight of 30 kg or greater is 1500 mg every 4 weeks for 13 cycles in combination with BCG induction and maintenance treatment. Patients should continue on treatment until recurrence of high-risk disease, disease progression, unacceptable toxicity, or a maximum of 13 cycles.

Data on durvalumab plus BCG

The approval is supported by data from the phase 3 POTOMAC trial (NCT03528694), which demonstrated that adding durvalumab to BCG induction and maintenance significantly improved disease-free survival (DFS) vs BCG induction and maintenance alone (HR, 0.68; 95% CI, 0.50 to 0.93; P = .0154).³ The median DFS was not reached in either arm.

The study enrolled 1018 patients with high-risk NMIBC, defined as having 1 of the following: T1 tumor, grade 3/high-grade tumor, carcinoma in situ (CIS), or multiple, recurrent, and large tumors. All patients were enrolled following transurethral resection of bladder tumor.

Participants in the study were randomly assigned 1:1:1 to receive durvalumab 1500 mg intravenously every 4 weeks for 13 cycles plus BCG induction and maintenance (n = 339), durvalumab 1500 mg intravenously every 4 weeks for 13 cycles plus BCG induction only (n = 339), or BCG induction and maintenance alone (n = 340). The study’s primary end point was DFS for durvalumab plus BCG induction/maintenance vs BCG induction/maintenance alone. DFS was defined as the time from randomization until first recurrence of high-risk NMIBC, persistent CIS, muscle invasive bladder cancer, metastatic disease, or death.

The trial met its primary end point, demonstrating a 32% reduction in risk of recurrence of high-risk disease or death by any cause with the addition of durvalumab to BCG induction/maintenance. The 24-month DFS rates were 86.5% in the durvalumab plus BCG induction/maintenance arm (95% CI, 82.2–89.8) and 81.6% in the BCG alone arm (95% CI, 76.9 to 85.3).

The study also showed no detriment to overall survival when adding durvalumab to BCG induction/maintenance (HR, 0.80; 95% CI, 0.53 to 1.20).

Adverse events (AEs) of any cause, maximum grade 3 or 4 AEs, serious AEs, AEs leading to death, and AEs leading to discontinuation of study treatment were all higher in the durvalumab plus BCG induction/maintenance arm. Grade 3 to 4 treatment-related AEs occurred in 21% of patients in the durvalumab plus BCG induction/maintenance arm and 4% of patients in the BCG induction/maintenance alone arm. There were no treatment-related AEs that led to death in any of the treatment arms.

The most commonly reported AEs included dysuria, hematuria, pollakiuria, urinary tract infection, cystitis, pyrexia, arthralgia, hypothyroidism, fatigue, diarrhea, rash, constipation, and increased lipase.

According to AstraZeneca,² the regimen is also under review in the European Union, Japan, and other countries.

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