AstraZeneca has announced positive high-level results from a planned interim analysis of the phase 3 VOLGA trial evaluating perioperative treatment with Imfinzi (durvalumab) in combination with neoadjuvant Enfortumab Vedotin for patients with Muscle-Invasive Bladder Cancer (MIBC). The study demonstrated statistically significant and clinically meaningful improvements in both event-free survival (EFS) and overall survival (OS) compared to the current standard of care in patients who were either ineligible for or declined cisplatin-based chemotherapy.

The comparator arm in the trial involved radical cystectomy, a surgical procedure to remove the bladder, with or without approved adjuvant treatment. AstraZeneca also reported that perioperative Imfinzi combined with Imjudo (tremelimumab) and neoadjuvant enfortumab vedotin achieved a statistically significant improvement in event-free survival and showed a favourable trend in overall survival, although the OS benefit did not yet reach statistical significance at this interim stage.

Muscle-invasive bladder cancer represents nearly one in four bladder cancer cases globally, with a significant proportion of patients unable to receive cisplatin-based chemotherapy because of kidney dysfunction or other health conditions. These patients often undergo surgery alone but continue to face high recurrence rates and poor long-term outcomes.

Thomas Powles, Professor and Chair of Barts Cancer Centre in London and International Coordinating Investigator for the VOLGA trial, said the results highlight the potential of perioperative durvalumab combined with enfortumab vedotin to significantly extend survival outcomes while maintaining a manageable safety profile in this difficult-to-treat patient population.

Susan Galbraith, Executive Vice President, Oncology Haematology R&D at AstraZeneca, said the VOLGA trial marks the company’s third positive phase 3 readout in bladder cancer following the NIAGARA and POTOMAC studies, reinforcing Imfinzi’s role as a potential immunotherapy backbone in early-stage, curative-intent bladder cancer treatment.

According to the company, the safety and tolerability profile of Imfinzi, with or without Imjudo plus enfortumab vedotin, remained consistent with the known profiles of the individual therapies, and no new safety concerns were identified during the study.

The VOLGA phase 3 trial enrolled 695 patients across 182 centres in 25 countries. The study evaluated perioperative Imfinzi with or without Imjudo alongside neoadjuvant enfortumab vedotin in patients undergoing radical cystectomy. The trial’s primary endpoint focused on event-free survival, while secondary endpoints included overall survival, disease-free survival, pathologic complete response and pathologic downstaging.

Imfinzi is currently approved in more than 40 countries for cisplatin-eligible muscle-invasive bladder cancer patients and is also being investigated across multiple cancer indications, including lung cancer, liver cancer and gastric cancer. Since its first approval in 2017, more than 414,000 patients globally have been treated with the therapy.