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A new treatment combo is changing the game for bladder cancer patients who can't tolerate standard chemo. 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 cisplatin-ineligible muscle-invasive bladder cancer (MIBC) patients. The FDA has already granted priority review to the combination.
A new treatment combination is reshaping the landscape for muscle-invasive bladder cancer (MIBC) patients who can't — or won't — tolerate cisplatin-based chemotherapy. Results from the phase 3 VOLGA trial, presented at the 2026 ESMO Congress and published simultaneously in the New England Journal of Medicine, showed that perioperative durvalumab (Imfinzi) plus neoadjuvant enfortumab vedotin (EV) significantly outperformed radical cystectomy alone on both event-free survival (EFS) and overall survival (OS).
The doublet regimen — three cycles of neoadjuvant EV plus durvalumab before surgery, followed by nine cycles of adjuvant durvalumab — delivered a pathologic complete response rate of 45%, compared to just 10% in the control arm. Notably, peripheral neuropathy (a known EV side effect) was minimal, likely because EV was limited to the pre-surgery phase. Adding a third drug, tremelimumab, improved EFS but not OS, and came with higher rates of immune-related side effects and more EV discontinuations — suggesting the triplet may blunt EV's effectiveness.
By the Numbers:
Why it matters: Up to half of MIBC patients are ineligible for cisplatin and historically face poor outcomes even after bladder removal surgery. This doublet regimen — already granted FDA priority review — could become the first perioperative standard of care for this underserved population, offering a meaningful survival benefit with a manageable safety profile.
