CAMBRIDGE, UK, May 14, 2026
AstraZeneca announced positive interim results from the global Phase III VOLGA trial, demonstrating that perioperative treatment with Imfinzi (durvalumab) combined with neoadjuvant enfortumab vedotin (EV) significantly improved both event-free survival (EFS) and overall survival (OS) in patients with muscle-invasive bladder cancer (MIBC) who were either ineligible for or declined cisplatin-based chemotherapy. The results position AstraZeneca’s immunotherapy strategy as a major advancement in early-stage bladder cancer treatment, particularly for patients with limited therapeutic options and high risk of disease recurrence following surgery.
VOLGA Trial Demonstrates Strong Survival Advantage
The VOLGA Phase III study evaluated perioperative Imfinzi with or without Imjudo (tremelimumab) in combination with neoadjuvant EV in comparison to radical cystectomy surgery with or without approved adjuvant therapy. High-level findings from the planned interim analysis showed that the Imfinzi plus EV regimen delivered a statistically significant and clinically meaningful improvement in event-free survival and overall survival versus standard treatment approaches.
Additionally, the combination of Imfinzi, Imjudo, and EV demonstrated a statistically significant improvement in EFS alongside a favorable trend toward improved OS. However, AstraZeneca noted that the OS benefit for this combination arm did not yet achieve statistical significance during the interim analysis and will be reassessed during future evaluations.
Muscle-invasive bladder cancer represents one of the most aggressive forms of bladder cancer, with tumors penetrating the bladder muscle wall and carrying a high likelihood of recurrence even after surgical bladder removal. Approximately 50% of MIBC patients are unable to receive cisplatin-based chemotherapy due to kidney impairment or other comorbidities, creating a substantial unmet need for safer and more effective perioperative treatment options.
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Thomas Powles, Professor and Chair of Barts Cancer Centre in London and international coordinating investigator for VOLGA, emphasized that the study results demonstrate that perioperative durvalumab combined with EV significantly extends survival outcomes with a manageable safety profile in this curative-intent setting.
Imfinzi Continues Expanding Bladder Cancer Leadership
AstraZeneca highlighted that the safety and tolerability profile of Imfinzi with or without Imjudo plus EV remained consistent with the known profiles of the individual medicines, with no new safety signals identified during the study. The company plans to present the detailed data at an upcoming medical meeting and submit findings to global regulatory authorities.
The VOLGA success marks AstraZeneca’s third positive bladder cancer Phase III readout, following earlier achievements in the NIAGARA and POTOMAC studies. The company stated that these combined findings establish a strong scientific foundation for Imfinzi as a core immunotherapy backbone across multiple bladder cancer treatment settings.
Imfinzi is already approved in more than 40 countries for cisplatin-eligible MIBC patients based on the NIAGARA Phase III trial. The therapy is also under regulatory review in multiple global markets for high-risk non-muscle-invasive bladder cancer following positive POTOMAC trial results.
Global Oncology Strategy Gains Momentum
The VOLGA trial enrolled 695 patients across 182 centers in 25 countries, making it one of the largest perioperative bladder cancer immunotherapy studies conducted to date. The study’s dual primary endpoints focused on event-free survival, while secondary endpoints included overall survival, pathological complete response, disease-free survival, and tumor downstaging.
Bladder cancer remains the ninth most common cancer worldwide, with more than 614,000 new cases diagnosed annually. Despite surgical intervention, approximately half of MIBC patients experience recurrence, underscoring the urgent need for therapies capable of reducing progression and improving long-term survival outcomes.
Susan Galbraith, Executive Vice President of Oncology Hematology R&D at AstraZeneca, stated that the VOLGA data further strengthen the company’s strategy to redefine bladder cancer treatment by integrating immunotherapy into earlier, potentially curative disease settings.
Source: AstraZeneca press release
