Positive results from the POTOMAC Phase III trial showed adding one year of treatment with AstraZeneca’s Imfinzi (durvalumab) to BCG induction and maintenance therapy demonstrated 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 to BCG treatment alone.

The results of this final analysis will be presented today during a late-breaking Proffered Paper session at the European Society for Medical Oncology (ESMO) Congress 2025 in Berlin, Germany (abstract #LBA108) and simultaneously published in The Lancet.

Maria De Santis, MD, Head of the Interdisciplinary Uro-Oncology Section at Charité – Universitätsmedizin Berlin, Germany, and a principal investigator in the POTOMAC trial, said: “While patients with early-stage bladder cancer are treated with the goal of cure, early recurrence is common among those with high-risk non-muscle-invasive bladder cancer. This can lead to repeated surgical procedures and more intensive treatment, including removing a patient’s bladder which deeply affects their quality of life. The results of POTOMAC showed that adding one year of durvalumab to BCG bladder instillation treatment reduced the risk of recurrence by 32 per cent, allowing more patients to remain disease-free and alive at two years.”

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “The early and sustained disease-free survival benefit observed in the POTOMAC trial demonstrates Imfinzi has the potential to change the course of high-risk non-muscle-invasive bladder cancer by extending the time patients live without high-risk disease recurrence or progression. These results build on Imfinzi’s practice-changing impact in muscle-invasive bladder cancer and further validate our strategy to bring novel therapies into earlier-stage disease where they can have the greatest impact on patients’ lives.”