AstraZeneca reported positive high-level results from the Phase 3 VOLGA trial evaluating perioperative Imfinzi (durvalumab) in combination with neoadjuvant enfortumab vedotin (EV) in patients with muscle-invasive bladder cancer (MIBC) who were ineligible for or declined cisplatin-based chemotherapy. At a planned interim analysis, the Imfinzi plus EV regimen delivered statistically significant and clinically meaningful improvements in both event-free survival (EFS) and overall survival (OS) versus standard of care.
In VOLGA, patients in the comparator arm received radical cystectomy with or without approved adjuvant treatment, reflecting current standard practice in this setting. By contrast, those in the investigational arms received perioperative Imfinzi-based combinations, including treatment before and after surgery. One regimen combined perioperative Imfinzi plus Imjudo (tremelimumab) with neoadjuvant EV, which achieved a statistically significant and clinically meaningful improvement in EFS and showed a favourable, though not yet statistically significant, trend for OS at the interim analysis.
AstraZeneca said the safety profile for the Imfinzi combinations in VOLGA was consistent with the known profiles of the individual medicines. Detailed data from the trial will be presented at an upcoming medical meeting and submitted to health authorities worldwide.
Susan Galbraith, Executive Vice President, Oncology Haematology R&D at AstraZeneca, said the interim results underscore the benefit of perioperative Imfinzi with neoadjuvant enfortumab vedotin compared with surgery-based standard care and help optimize treatment options for eligible patients. She noted that VOLGA is the company’s third positive bladder cancer readout alongside the NIAGARA and POTOMAC Phase 3 studies, strengthening the foundation for Imfinzi as an immunotherapy backbone in early-stage, curative-intent bladder cancer.
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