AstraZeneca’s IMFINZI (durvalumab) in combination with Bacillus Calmette-Guérin induction and maintenance therapy has been approved by the US Food and Drug Administration for adult patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer.
The approval is based on the POTOMAC Phase III trial; according to the company, adding one year of IMFINZI to BCG reduced the risk of high-risk disease recurrence, progression or death by 32% versus BCG alone after one year (disease-free survival hazard ratio 0.68; 95% confidence interval 0.50-0.93; P=0.0154).
With a median follow-up of 60.7 months, the regimen delivered an early and sustained disease-free survival benefit, and the estimated median disease-free survival had not yet been reached.
The company claims safety with IMFINZI plus BCG was consistent with the known safety profiles of the individual medicines, with no new safety signals, did not compromise patients’ ability to complete BCG therapy, and had no meaningful impact on patient-reported quality of life.
Regulatory submissions based on POTOMAC results are under review in the European Union, Japan and other countries. The company also noted that in 2024, more than 31,000 people in the US were treated for high-risk non-muscle-invasive bladder cancer.
