IMFINZI® Approved as the First and Only Immunotherapy Combo for BCG-Naïve, High-Risk Non-Muscle-Invasive Bladder Cancer in the US

Key Takeaways

AstraZeneca’s IMFINZI is now FDA-approved alongside BCG for high-risk non-muscle-invasive bladder cancer.
The POTOMAC trial showed a 32% reduction in disease recurrence, progression, or death with IMFINZI compared to BCG alone.
The regimen represents the first new treatment strategy for BCG-naïve patients in over 30 years.

The FDA has approved AstraZeneca’s IMFINZI® (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) therapy for adult patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC). This decision is based on positive results from the POTOMAC Phase III trial, recently presented at the European Society for Medical Oncology (ESMO) Congress 2025 and published in The Lancet.

In 2024, more than 31,000 individuals in the United States were treated for high-risk NMIBC. Standard treatment typically involves tumor resection followed by BCG therapy. Approximately half of the patients are categorized as high-risk due to features such as tumor grade and stage, with up to 80% experiencing disease recurrence within five years.

Neal Shore, MD, a co-principal investigator in the trial, emphasized the significance of this approval, noting it is the first new therapy for BCG-naïve, high-risk NMIBC in over three decades. The combination of IMFINZI and BCG therapy resulted in a 32% reduction in the chance of disease recurrence, progression, or death in comparison to BCG alone.

Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Haematology Business Unit, stated that this approval marks a pivotal shift in treatment protocols, enhancing early disease-free survival for patients at risk of rapid recurrence. Meri-Margaret Deoudes, CEO of the Bladder Cancer Advocacy Network, highlighted the critical need for innovative treatments, expressing optimism about the potential impact of this new option for patients and their families.

The POTOMAC trial showed that a year of IMFINZI treatment alongside BCG led to a 32% decrease in the risk of high-risk disease recurrence and progression, based on a disease-free survival hazard ratio of 0.68. With over five years of follow-up, the regimen exhibited early and sustained benefits starting within four months of initiating treatment.

Additionally, the safety profile of IMFINZI when combined with BCG was consistent with prior findings, revealing no new safety signals. The therapy did not significantly affect the completion rates of BCG treatment, nor did it adversely impact patient-reported quality of life.

Regulatory reviews of the POTOMAC results are ongoing in the European Union, Japan, and other countries. AstraZeneca has also reported favorable findings from the VOLGA Phase III trial, which showcases the efficacy of IMFINZI in combination with neoadjuvant enfortumab vedotin for muscle-invasive bladder cancer.

IMFINZI itself is a human monoclonal antibody designed to counter tumor immune evasion, currently indicated for various forms of bladder and lung cancer. The recent FDA approval represents a significant advancement in the treatment landscape for high-risk NMIBC, offering renewed hope for patients facing this challenging diagnosis.

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