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A new treatment combo is changing the game for muscle-invasive bladder cancer. Phase 3 VOLGA trial data presented at the 2026 ESMO Congress showed that perioperative durvalumab plus neoadjuvant enfortumab vedotin cut the risk of disease progression or death by nearly half compared to surgery alone in cisplatin-ineligible patients. The FDA has already granted priority review to the combination, with a decision expected in Q4 2026.
A powerful new treatment combination is reshaping how doctors approach muscle-invasive bladder cancer (MIBC) in patients who can't tolerate standard cisplatin-based chemotherapy. Full results from the phase 3 VOLGA trial, presented at the 2026 ESMO Congress, showed that perioperative durvalumab (Imfinzi) paired with neoadjuvant enfortumab vedotin (Padcev) significantly outperformed upfront radical cystectomy alone — cutting the risk of disease events nearly in half and improving overall survival.
The doublet regimen involved three neoadjuvant cycles of the combination before surgery, followed by nine cycles of adjuvant durvalumab. A triplet arm adding tremelimumab also improved event-free survival, though its overall survival benefit didn't reach statistical significance at interim analysis. The FDA has already granted priority review to the doublet, with a regulatory decision expected in Q4 2026.
By the Numbers:
Why it matters: Up to half of MIBC patients are ineligible for cisplatin, leaving them with limited options in a curative-intent setting. This regimen could become the first perioperative standard of care for this population, offering a meaningful survival benefit with a manageable safety profile.
