AstraZeneca's Imfinzi-Enfortumab Vedotin Combination Shows Historic Survival Gains in Bladder Cancer Trial

AstraZeneca announced on May 14, 2026 that its Phase III VOLGA trial of 695 participants demonstrated statistically significant improvements in both Event-Free Survival and Overall Survival for the Imfinzi (durvalumab) plus enfortumab vedotin combination in cisplatin-ineligible muscle-invasive bladder cancer patients. The perioperative regimen represents the first immunotherapy-based combination to show definitive Overall Survival benefit in this population.

VOLGA trial results

• ▪The VOLGA trial's planned interim analysis showed the Imfinzi plus enfortumab vedotin regimen demonstrated statistically significant and clinically meaningful improvements in both Event-Free Survival and Overall Survival compared to the standard of care.
• ▪The Phase III VOLGA trial demonstrated that perioperative Imfinzi (durvalumab) plus neoadjuvant enfortumab vedotin significantly improves survival outcomes in muscle-invasive bladder cancer patients ineligible for cisplatin-based chemotherapy.
• ▪In the VOLGA trial, the triplet combination of Imfinzi plus Imjudo (tremelimumab) plus enfortumab vedotin showed a statistically significant Event-Free Survival improvement and a favorable trend in Overall Survival.
• ▪In the VOLGA trial, the combination of Imfinzi plus enfortumab vedotin met the dual primary endpoints of Event-Free Survival and a key secondary endpoint of Overall Survival.
• ▪The Phase III VOLGA trial is a randomized, open-label, multi-center global study that enrolled 695 participants.
• ▪The safety profile of the Imfinzi plus enfortumab vedotin regimen in the VOLGA trial was consistent with the known profiles of the individual medicines, with no new safety signals identified.

Imfinzi EV combination therapy

• ▪The perioperative Imfinzi plus enfortumab vedotin combination represents the first perioperative immunotherapy-based combination to show a definitive Overall Survival benefit in cisplatin-ineligible muscle-invasive bladder cancer patients.
• ▪The Imfinzi plus enfortumab vedotin therapy integrates treatment into the early stages of muscle-invasive bladder cancer care, both before and after surgery.
• ▪AstraZeneca announced high-level results from the Phase III VOLGA trial on May 14, 2026.

Muscle-invasive bladder cancer treatment

• ▪AstraZeneca's POTOMAC trial evaluated Imfinzi for non-muscle-invasive bladder cancer disease.
• ▪Nearly 50% of muscle-invasive bladder cancer patients experience disease recurrence after radical cystectomy surgery.
• ▪Radical cystectomy is a standard surgical intervention for muscle-invasive bladder cancer that involves surgery to remove the bladder.
• ▪AstraZeneca's NIAGARA trial established Imfinzi in cisplatin-eligible muscle-invasive bladder cancer settings.
• ▪In the VOLGA trial comparator arm, patients underwent radical cystectomy with or without approved adjuvant treatments.

Cisplatin-ineligible patient population

• ▪Cisplatin-ineligible muscle-invasive bladder cancer patients have long faced limited curative-intent treatment options.
• ▪Up to half of patients with muscle-invasive bladder cancer are not eligible for cisplatin-based chemotherapy.
• ▪Cisplatin-ineligible muscle-invasive bladder cancer patients face high rates of disease recurrence.

Survival outcome improvements

• ▪The VOLGA trial evaluated Event-Free Survival as a primary endpoint and Overall Survival as a key secondary endpoint.
• ▪Perioperative durvalumab significantly extends survival when combined with neoadjuvant enfortumab vedotin in cisplatin-ineligible muscle-invasive bladder cancer patients.
• ▪Bladder cancer is the 9th most common cancer globally, with over 614,000 new cases diagnosed annually.

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