VOLGA: perioperative durvalumab plus enfortumab vedotin improves EFS and OS in cisplatin-ineligible MIBC

Phase 3 RCT · N Engl J Med · 2026-10-24. Number 2 in the UrologyWatch Top 5 for October 26, 2026.

In 695 patients with MIBC who were cisplatin-ineligible or declined cisplatin (median follow-up 23 months), perioperative durvalumab plus neoadjuvant enfortumab vedotin improved event-free survival versus upfront cystectomy (HR 0.51, 95% CI 0.38 to 0.67; 24-month EFS 64% vs 45%) and overall survival (HR 0.58; 24-month OS 78% vs 69%). pCR was 45% vs 10%. Adding tremelimumab improved EFS (HR 0.61) but not OS at this interim analysis.

Why it matters: Supports perioperative enfortumab vedotin with checkpoint blockade for patients who cannot receive or decline cisplatin; the FDA has granted the doublet priority review.

Limitation: Open-label trial in cisplatin-ineligible or cisplatin-declining patients; OS benefit is from an interim analysis.

Source: N Engl J Med · DOI 10.1056/NEJMoa2608323

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