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# Positive Data with Imfinzi Regimen in Bladder Cancer
- URL: https://www.fdaweb.com/positive-data-with-imfinzi-regimen-in-bladder-cancer/
- Published: 2026-05-14T12:00:00.000Z
- Updated: 2026-09-14T13:39:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161147

AstraZeneca says perioperative treatment with Imfinzi (durvalumab) combined with neoadjuvant enfortumab vedotin (EV) (Astellas/Pfizer's Padcev) significantly improved event-free survival and overall survival in patients with muscle-invasive bladder cancer who were ineligible for or declined cisplatin chemotherapy, according to interim Phase 3 VOLGA trial results released 5/14.

The company said the regimen of Imfinzi plus EV met the trial’s primary endpoint by demonstrating statistically significant and clinically meaningful improvements in event-free survival compared with standard treatment consisting of radical cystectomy with or without approved adjuvant therapy.

A second investigational regimen combining perioperative Imfinzi, AstraZeneca's Imjudo (tremelimumab) and neoadjuvant EV also showed statistically significant improvement in event-free survival and a favorable trend in overall survival, although the overall survival benefit did not reach statistical significance at the interim analysis.

“Up to half of patients with muscle-invasive bladder cancer are not eligible for cisplatin and face high rates of disease recurrence, even after having their bladder removed,” a company release says.“The VOLGA results show that perioperative durvalumab significantly extends event-free survival and overall survival when combined with neoadjuvant enfortumab vedotin, with a manageable safety profile.”

Muscle-invasive bladder cancer accounts for roughly one-quarter of bladder cancer cases globally. Although cisplatin-based chemotherapy combined with radical cystectomy remains a standard approach, as many as 50% of patients are considered ineligible for cisplatin because of renal impairment or other comorbidities, according to the company.

AstraZeneca says detailed VOLGA data will be presented at an upcoming medical meeting and submitted to global regulatory authorities.