WILMINGTON, DE — AstraZeneca announced that its IMFINZI (durvalumab) regimen significantly reduced the risk of disease recurrence or death by 32 percent in patients with high-risk, non-muscle-invasive bladder cancer (NMIBC) who were new to Bacillus Calmette-Guérin (BCG) therapy, according to final results from the Phase III POTOMAC trial.
The findings, presented at the European Society for Medical Oncology (ESMO) Congress 2025 and published in The Lancet, demonstrated that adding one year of IMFINZI treatment to standard BCG therapy produced a statistically significant and sustained improvement in disease-free survival (DFS) compared to BCG alone.
After a median follow-up of more than five years, the combination therapy showed a 32 percent reduction in the risk of high-risk recurrence or death, corresponding to a hazard ratio of 0.68. At the two-year mark, 87 percent of patients receiving IMFINZI remained alive and disease-free versus 82 percent for those who received only BCG.
Dr. Maria De Santis, Head of the Interdisciplinary Uro-Oncology Section at Charité – Universitätsmedizin Berlin and a principal investigator in the trial, stated that early recurrence remains common among high-risk patients and often leads to repeated surgical procedures or even bladder removal. “Adding one year of durvalumab to BCG bladder instillation treatment reduced the risk of recurrence by 32 percent, allowing more patients to remain disease-free and alive at two years,” she said.
Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, noted that the results highlight IMFINZI’s potential to reshape treatment for early-stage bladder cancer. “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,” she said.
The safety profile of IMFINZI combined with BCG was consistent with previously known data for both drugs. Severe adverse events occurred in 34 percent of patients receiving IMFINZI versus 17 percent in the BCG-only arm, but no new safety concerns were identified.
Bladder cancer is the ninth most common cancer globally, with over 614,000 new cases diagnosed annually. Among those, roughly 70 percent are NMIBC cases. High-risk NMIBC patients face up to an 80 percent recurrence rate within five years under current treatments, underscoring the demand for more durable therapies.
The POTOMAC trial included more than 1,000 patients across 12 countries. AstraZeneca said the data reinforce its goal of expanding immunotherapy to earlier stages of cancer where long-term survival benefits can be maximized.
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