Perioperative IMFINZI® (durvalumab) plus neoadjuvant enfortumab vedotin reduced risk of recurrence by 49% and risk of death by 42% in muscle-invasive bladder cancer

More than three quarters of patients were still alive two years after treatment with perioperative IMFINZI plus three cycles of EV given before surgery

Data demonstrated statistically significant and clinically meaningful survival benefit and manageable safety profile

WILMINGTON, Del., October 24, 2026--Positive results from the VOLGA Phase III trial showed perioperative treatment with AstraZeneca's IMFINZI® (durvalumab) in combination with neoadjuvant enfortumab vedotin (EV) demonstrated statistically significant and clinically meaningful improvements in the primary endpoint of event-free survival (EFS) and key secondary endpoint of overall survival (OS) in patients with muscle-invasive bladder cancer (MIBC) versus standard of care. Patients were ineligible for or had refused cisplatin-based chemotherapy. Patients in the comparator arm had a radical cystectomy (surgery to remove the bladder) with or without approved adjuvant treatment.

These results will be presented today in a Proffered Paper session during Presidential Symposium I at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain (abstract #LBA2).1 They were also simultaneously published in The New England Journal of Medicine.

In a planned interim analysis, perioperative IMFINZI plus neoadjuvant EV demonstrated a 49% reduction in the risk of disease progression, recurrence, not undergoing surgery or death versus the comparator arm (based on an EFS hazard ratio [HR] of 0.51; 95% confidence interval [CI] 0.38-0.67; p<0.0001). Estimated median EFS was not yet reached for the IMFINZI combination versus 12.1 months for the comparator arm. An estimated 64% of patients treated with the IMFINZI combination remained alive and event-free at two years compared to 45% in the comparator arm.

Results from the key secondary endpoint of OS showed that the IMFINZI combination reduced the risk of death by 42% compared to the comparator arm (based on an OS HR of 0.58; 95% CI 0.40-0.83; p=0.0027). Estimated median OS was not yet reached for the IMFINZI combination or comparator arm. An estimated 78% of patients treated with the IMFINZI combination were alive at two years compared to 69% in the comparator arm.

Thomas Powles, MD, Professor, Chair of Barts Cancer Centre, Barts Health NHS Trust, London, UK, and international coordinating investigator for the VOLGA trial, said: "Patients with muscle-invasive bladder cancer require life-changing bladder removal surgery. Despite this, the cancer returns in about half of patients. A new regimen of perioperative durvalumab combined with enfortumab vedotin before surgery reduced the risk of death by 42%, with a manageable safety profile. These practice-changing results support this approach as a patient centric, potential new standard of care in this setting."