ESMO 2026 | VOLGA: perioperative durvalumab and neoadjuvant enfortumab vedotin in MIBC

The VOLGA trial is a three-armed study. It’s perioperative durvalumab, plus or minus tremelimumab, with neoadjuvant enfortumab-vedotin versus standard-of-care cystectomy in cisplatin-ineligible or cisplatin-refusing muscle-invasive bladder cancer. The study is important because it’s the first time we’ve looked at de-escalation therapy. It’s only three neoadjuvant cycles. The standard of care currently is six cycles of chemotherapy, not nine cycles of EVP, but here we’ve given three cycles of neoadjuvant EV durvalumab and that year overall of perioperative durvalumab. There was a second arm with tremelimumab, which I’m not going to talk about today, but we presented today and is available. The patient population is muscle-invasive bladder cancer. It’s classic cisplatin-ineligible or cisplatin-refusing, cystectomy population. The control arm performed as one would expect. The results showed a significant delay in event-free survival and a significant improvement in overall survival for the doublet, the EV-durvalumab doublet. What it showed was hazard ratios of 0.51 and hazard ratios of 0.58. These are clinically meaningful. We also showed from a toxicity perspective, the doublet was well tolerated. Remember, we didn’t give any adjuvant therapy. And when we looked at the quality of life data and the toxicity, it looked very similar in terms of tracking with cystectomy alone. Now, this is quite attractive for patients as they recover from cystectomy. Overall, when you look at the results of the VOLGA trial with that doublet, you can say this is a new option for patients in this environment. It’s a patient-friendly option, and it’s associated with great outcomes.

This transcript is AI-generated. While we strive for accuracy, please verify this copy with the video.