Perioperative Imfinzi plus enfortumab vedotin lowers recurrence and death risk in bladder cancer
AstraZeneca said the VOLGA Phase III trial showed perioperative Imfinzi plus neoadjuvant enfortumab vedotin lowered the risk of disease progression, recurrence, missed surgery, or death by 49% in muscle-invasive bladder cancer. The regimen also cut the likelihood of death by 42% compared with surgery with or without approved postoperative treatment. Survival benefits came with higher rates of Grade 3–4 adverse events.
In the VOLGA Phase III study, patients with muscle-invasive bladder cancer who could not receive or declined cisplatin chemotherapy were assigned to the Imfinzi–enfortumab vedotin regimen before surgery or to bladder removal with or without approved adjuvant therapy. At a planned interim look, the combination cut the composite risk of progression, recurrence, missed surgery, or death by 49%, with median event-free survival not reached versus 12.1 months.
Two-year event-free survival was estimated at 64% versus 45%, and overall survival at 78% versus 69%; the death-risk reduction was 42%. The trial also reported more Grade 3–4 side effects with the combination. Results were presented at ESMO 2026 and published in NEJM.
If adopted, this perioperative approach could affect patients with muscle-invasive bladder cancer who cannot or choose not to receive cisplatin-based chemotherapy, along with surgeons, oncology teams, and payers. A lower recurrence and death risk may mean more patients live longer and potentially avoid some downstream care, while higher Grade 3–4 adverse events could increase monitoring and treatment burdens. Access, cost, and health-system capacity may shape how broadly the regimen is used.