High-level results from the phase 3 VOLGA trial show that combining durvalumab (Imfinzi) with enfortumab vedotin (Padcev) before surgery significantly improves survival for patients with muscle-invasive bladder cancer who cannot receive or choose not to receive cisplatin chemotherapy. The treatment improved both event-free survival and overall survival compared with surgery alone.
Another treatment group using durvalumab, tremelimumab, and enfortumab vedotin also showed better event-free survival and a positive trend in overall survival, although the overall survival result did not reach statistical significance at this interim analysis.
Researchers said the safety results were consistent with the known side effects of the medicines, and no new safety concerns were identified.
The study addresses a major unmet need because about half of patients with muscle-invasive bladder cancer are not eligible for cisplatin treatment and often face a high risk of cancer recurrence after bladder removal surgery. The strategy uses enfortumab vedotin to shrink tumors before surgery, followed by immunotherapy to help prevent relapse.
The findings further strengthen the role of durvalumab as an important treatment option in earlier-stage bladder cancer. Detailed trial data will be presented at a future medical meeting and submitted to regulatory agencies for review.