WILMINGTON, Del.—AstraZeneca announced positive results from the Phase III POTOMAC trial showing that adding one year of IMFINZI (durvalumab) treatment to Bacillus Calmette-Guérin (BCG) induction and maintenance therapy led to a statistically significant and clinically meaningful improvement in disease-free survival (DFS) for patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC), compared with BCG therapy alone.
The findings from the final analysis were presented at the European Society for Medical Oncology (ESMO) Congress 2025 in Berlin, Germany, and simultaneously published in The Lancet.
After a median follow-up of more than five years (60.7 months), the IMFINZI regimen reduced the risk of high-risk disease recurrence or death by 32 percent versus BCG alone, with a hazard ratio (HR) of 0.68 (95% CI: 0.50–0.93; P=0.0154). Median DFS was not yet reached in either arm. At two years, 87 percent of patients receiving IMFINZI remained alive and disease-free, compared with 82 percent of those in the comparator arm.
While the trial was not powered to test overall survival (OS) formally, an exploratory analysis after 65.6 months of median follow-up (14 percent maturity) showed an OS HR of 0.80 (95% CI: 0.53–1.20), indicating no detriment to overall survival.
“While early-stage bladder cancer is treated with curative intent, recurrence remains common among high-risk patients, often leading to repeated surgeries or even bladder removal,” said Maria De Santis, M.D., Head of the Interdisciplinary Uro-Oncology Section at Charité – Universitätsmedizin Berlin and a principal investigator in the POTOMAC trial. “The results of POTOMAC show that adding one year of durvalumab to BCG therapy reduced the risk of recurrence by 32 percent, enabling more patients to remain disease-free and preserve their quality of life.”
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, added, “The early and sustained disease-free survival benefit seen in POTOMAC demonstrates IMFINZI’s potential to reshape treatment for high-risk non-muscle-invasive bladder cancer by extending the time patients live without recurrence or progression. These findings build on IMFINZI’s established role in muscle-invasive bladder cancer and support our commitment to advancing novel therapies earlier in the disease course, where they can deliver the greatest impact.”
