Turn on cookies to sign in
Signing in saves your progress to your Curie account. We can only do that with cookies on — turn them on to continue.
A new drug combo is changing the game for muscle-invasive bladder cancer. The phase 3 VOLGA trial found that perioperative durvalumab plus neoadjuvant enfortumab vedotin significantly improved both event-free survival and overall survival compared to surgery alone in patients who can't tolerate cisplatin. The FDA has granted the regimen priority review, with a decision expected by end of 2026.
A new treatment combination is showing strong results for patients with muscle-invasive bladder cancer (MIBC) who can't receive or decline cisplatin. Data from the phase 3 VOLGA trial, presented at the 2026 ESMO Congress and simultaneously published in the New England Journal of Medicine, show that perioperative durvalumab plus neoadjuvant enfortumab vedotin (EV) significantly outperformed upfront radical cystectomy alone on both event-free survival (EFS) and overall survival (OS).
The trial enrolled 695 patients randomized across three arms: a durvalumab + EV doublet, a durvalumab + tremelimumab + EV triplet, and a control arm (surgery ± standard adjuvant therapy). The doublet arm showed the strongest results, with both EFS and OS benefits, while the triplet improved EFS but did not reach statistical significance for OS at this interim analysis. The FDA has granted priority review to the sBLA for the doublet regimen, with an action date set for Q4 2026.
By the Numbers:
Why it matters: Up to half of MIBC patients are ineligible for cisplatin and face high recurrence rates even after bladder removal. If approved, this perioperative regimen — with EV given only before surgery — could become a new standard of care in a setting where better options are urgently needed.
