Imfinzi Cuts Recurrence Risk by 32% and Wins FDA Approval in High-Risk NMIBC

AstraZeneca has secured U.S. Food and Drug Administration (FDA) approval for Imfinzi® (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy for adults with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC) following transurethral resection of bladder tumors (TURBT). The approval introduces the first new treatment option in more than three decades for this patient population and marks the first immunotherapy-based combination approved in this setting.

More than 70% of bladder cancer cases are diagnosed as NMIBC. Patients with high-risk disease face a substantial risk of recurrence and progression despite standard BCG therapy, often requiring repeated procedures and, in some cases, bladder removal.

Phase 3 POTOMAC Delivers Durable Benefit

The approval is supported by results from the global, randomized Phase 3 POTOMAC trial (NCT03528694), which enrolled 1,018 patients across more than 120 centers. Participants received Imfinzi plus BCG induction and maintenance therapy, Imfinzi plus BCG induction alone, or standard BCG induction and maintenance therapy.

The Imfinzi+BCG induction and maintenance regimen met the primary endpoint of disease-free survival, reducing the risk of recurrence, progression, or death by 32% compared with BCG alone (HR=0.68; 95% CI: 0.50–0.93; p=0.0154). With a median follow-up of 60.7 months, the combination delivered an early and sustained benefit that emerged within four months of treatment initiation. The Imfinzi+BCG induction-only arm did not demonstrate a statistically significant improvement.

Safety findings were consistent with the established profiles of Imfinzi and BCG. Investigators reported no new safety signals, no meaningful impact on patient-reported quality of life, and no reduction in patients’ ability to complete BCG therapy. The regimen may also help reduce repeat surgeries and delay progression to muscle-invasive disease requiring cystectomy.

Expert and Stakeholder Perspectives

Neal Shore, MD, FACS, co-principal investigator of POTOMAC, said the approval represents the first new therapy in more than 30 years for BCG-naïve, high-risk NMIBC and could substantially reduce recurrence and progression risks.

Dave Fredrickson, EVP of AstraZeneca’s Oncology Haematology Business Unit, noted that the approval brings the first immunotherapy combination to this early bladder cancer setting and builds on Imfinzi’s expanding role across bladder cancer.

Meri-Margaret Deoudes, CEO of the Bladder Cancer Advocacy Network, emphasized the urgent need for therapies that reduce the burden of recurrent disease and invasive procedures, adding that the approval offers meaningful hope for patients and families.

Expanding Imfinzi’s Bladder Cancer Footprint

Imfinzi is a PD-L1 blocking monoclonal antibody that restores anti-tumor immune activity by preventing cancer cells from suppressing T-cell responses. The therapy is already approved across multiple solid tumors and continues to move into earlier-stage cancer settings.

Regulatory submissions based on POTOMAC remain under review in the European Union, Japan, and other markets. The approval further expands Imfinzi’s role in bladder cancer, where it is also being evaluated in muscle-invasive and advanced disease through the Phase 3 VOLGA, NIAGARA, and NILE programs. FDA has approved Imfinzi® (durvalumab) as the first and only perioperative immunotherapy for early-stage gastric and gastroesophageal cancers.

Reference

Imfinzi approved in the US in first and only immunotherapy combination for patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer.