AstraZeneca announced positive interim results from the Phase III VOLGA clinical trial, showing that perioperative treatment with Imfinzi combined with neoadjuvant enfortumab vedotin (EV) significantly improved outcomes for patients with muscle-invasive bladder cancer (MIBC) who were unable to receive or declined cisplatin-based chemotherapy.
According to the planned interim analysis, the treatment regimen demonstrated statistically significant and clinically meaningful improvements in event-free survival (EFS) compared with standard treatment, which consisted of radical cystectomy, or bladder removal surgery, with or without approved adjuvant therapy. Researchers also reported a favorable trend in overall survival (OS), suggesting the combination may help extend patients’ lives, although the OS data did not yet reach statistical significance at this stage of analysis.
The study also evaluated perioperative Imfinzi in combination with Imjudo and neoadjuvant EV. This regimen similarly achieved a statistically significant improvement in EFS and showed encouraging overall survival trends. Final conclusions regarding OS will be assessed in a future analysis as additional data mature.
Muscle-invasive bladder cancer remains a major clinical challenge, particularly for patients who cannot tolerate cisplatin chemotherapy due to kidney impairment or other underlying health conditions. Experts estimate that nearly half of patients with MIBC are ineligible for cisplatin-based treatment. Historically, many of these individuals have relied primarily on radical cystectomy, despite the high risk of disease recurrence following surgery.
Thomas Powles, Professor and Chair of Barts Cancer Centre at Queen Mary University of London and international coordinating investigator for the VOLGA trial, said the findings address a significant unmet medical need. He noted that patients who cannot receive cisplatin often face poor long-term outcomes, even after major surgery. According to Powles, the trial demonstrated that perioperative durvalumab combined with neoadjuvant EV significantly extended both event-free and overall survival while maintaining a manageable safety profile.
Susan Galbraith, Executive Vice President of Oncology Haematology R&D at AstraZeneca, described the results as another milestone in the company’s expanding bladder cancer program. She said the VOLGA findings, together with positive data from the NIAGARA and POTOMAC trials, strengthen the position of Imfinzi as a potential immunotherapy backbone in early-stage bladder cancer treatment.
Safety findings from the VOLGA study were consistent with the known profiles of the individual medicines, and researchers reported no new safety concerns. AstraZeneca said the detailed data will be presented at an upcoming medical conference and submitted to global regulatory agencies for review.
Imfinzi is already approved in more than 40 countries for cisplatin-eligible muscle-invasive bladder cancer patients based on results from the NIAGARA Phase III trial. The therapy is also under regulatory review for additional bladder cancer indications in the United States, European Union, Japan, and other markets.