AstraZeneca’s Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy has been approved in the US as the first immunotherapy combination for adult patients with BCG-naïve, high-risk non–muscle-invasive bladder cancer (NMIBC). The regimen is indicated in a curative-intent setting where current standard of care consists of tumor resection followed by intravesical BCG, and it targets patients at elevated risk of early disease recurrence or progression.
The Food and Drug Administration’s decision is based on positive results from the Phase 3 POTOMAC trial, which were presented at the 2025 European Society for Medical Oncology Congress and published in The Lancet. In 2024, more than 31,000 people in the US were treated for high-risk NMIBC. About half of NMIBC patients fall into a high-risk category defined by tumor grade, stage, and specific tumor features, and up to 80% of those high-risk patients experience disease recurrence within five years of treatment.
In POTOMAC, adding one year of Imfinzi to BCG induction and maintenance therapy reduced the risk of high-risk disease recurrence, progression, or death by 32% versus BCG alone, corresponding to a disease-free survival (DFS) hazard ratio of 0.68 (95% CI 0.50–0.93; p=0.0154). With a median follow-up of 60.7 months, the Imfinzi regimen delivered an early and sustained DFS benefit beginning less than four months after treatment initiation, and estimated median DFS was not reached in either study arm.
Neal Shore, MD, FACS, director of START Carolinas and head of the Carolina Urologic Research Center and a co‑principal investigator in POTOMAC, noted that the durvalumab plus BCG regimen is the first new therapy in more than 30 years for BCG-naïve, high-risk NMIBC. He said many patients face repeated recurrences requiring multiple procedures and, in some cases, disease progression that leads to surgical bladder removal. Shore said the trial shows the combination reduced the risk of recurrence, progression, or death by almost a third versus BCG alone and represents a marked advance for this patient population.
Dave Fredrickson, executive vice president of AstraZeneca’s Oncology Haematology Business Unit, said the approval brings the first immunotherapy combination regimen to US patients with BCG-naïve, high-risk NMIBC and extends the impact Imfinzi is already having in muscle-invasive disease. He emphasized that the early and durable DFS benefit seen with Imfinzi plus BCG in POTOMAC is an important step forward for patients at risk of early recurrence and signals a potential shift in the standard of care.
Meri-Margaret Deoudes, CEO of the Bladder Cancer Advocacy Network, said patients with high-risk NMIBC often face frequent, early recurrences and the threat of progression to more advanced disease requiring life-changing surgery. She called new, effective treatment options that address this burden “always good news” and said the Imfinzi approval could offer meaningful hope for patients and their families.
The safety and tolerability profile of Imfinzi plus BCG in POTOMAC was consistent with the known profiles of each therapy, with no new safety signals identified over more than five years of DFS follow-up. AstraZeneca reported that adding Imfinzi did not interfere with patients’ ability to complete BCG induction and maintenance and did not have a meaningful impact on patient-reported quality of life. Regulatory submissions for the Imfinzi-BCG regimen based on POTOMAC are under review in the European Union, Japan, and several other countries.
AstraZeneca also recently reported positive high-level results from the VOLGA Phase 3 trial, in which perioperative Imfinzi plus neoadjuvant enfortumab vedotin (EV) improved event-free survival and overall survival in patients with muscle-invasive bladder cancer (MIBC) who were ineligible for or declined cisplatin-based chemotherapy. A regimen of perioperative Imfinzi plus Imjudo (tremelimumab) with neoadjuvant EV in VOLGA showed a significant event-free survival benefit and a favorable but not yet statistically significant trend in overall survival at interim analysis.
Imfinzi is already approved in several countries for patients with cisplatin-eligible MIBC based on the NIAGARA Phase 3 trial and continues to be studied in locally advanced or metastatic disease in the NILE Phase 3 trial.
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