AZN · AstraZeneca PLC

The VOLGA Phase III trial addresses a critical unmet need in muscle-invasive bladder cancer (MIBC), affecting approximately one in four bladder cancer patients without distant metastases, where up to 50% are ineligible for cisplatin due to renal impairment or comorbidities. These patients face high recurrence rates post-radical cystectomy, the historical standard. High-level interim results demonstrate perioperative durvalumab (Imfinzi) combined with neoadjuvant enfortumab vedotin (EV) delivers statistically significant and clinically meaningful improvements in dual primary endpoint event-free survival (EFS)—time from randomization to recurrence, progression, cystectomy failure, or death—and overall survival (OS) versus surgery with or without adjuvant therapy. The Imfinzi + Imjudo + EV arm also met EFS significance with a favorable OS trend pending future assessment. Trial design randomized 695 patients 1:1:1 to two experimental arms or comparator, conducted globally across Europe, North America, South America, and Asia. Safety was manageable and aligned with individual drug profiles, supporting potential adoption in curative-intent settings. This bolsters Imfinzi's position as the immunotherapy backbone in early-stage bladder cancer, following NIAGARA (cisplatin-eligible MIBC approval in over 40 countries) and POTOMAC (high-risk non-muscle-invasive). Results will inform regulatory submissions, potentially expanding addressable patients and reinforcing AstraZeneca's oncology leadership in immuno-oncology combinations.