AstraZeneca posts positive Phase III VOLGA bladder cancer data

AstraZeneca said on May 14 that the Phase III VOLGA trial met key goals in muscle-invasive bladder cancer, with perioperative Imfinzi (durvalumab) plus neoadjuvant enfortumab vedotin improving both event-free survival and overall survival versus standard care in patients who were ineligible for, or declined, cisplatin-based chemotherapy. The company also said a three-drug arm adding tremelimumab improved event-free survival, but overall survival was not yet statistically significant at this interim analysis. VOLGA enrolled cisplatin-ineligible patients with resectable muscle-invasive disease, a group that has often had limited options beyond cystectomy alone. (investegate.co.uk)

Why it matters: This is another sign that perioperative immunotherapy-plus-ADC combinations are reshaping bladder cancer care, especially for patients who can't receive cisplatin. Imfinzi already won a U.S. approval in March 2025 in cisplatin-eligible muscle-invasive bladder cancer when paired with gemcitabine and cisplatin, and pembrolizumab plus enfortumab vedotin was approved in November 2025 for cisplatin-ineligible patients. VOLGA now positions AstraZeneca to compete in that cisplatin-ineligible setting, while giving clinicians more evidence that surgery alone may no longer be enough for many patients in this population. (fda.gov)

What to watch: Watch for full data presentation, regulatory submissions, and whether detailed safety, pathologic complete response, and subgroup results support a filing in cisplatin-ineligible disease. (investegate.co.uk)