HMN 2026: How Perioperative enfortumab vedotin + pembrolizumab are tied to improved outcomes with bladder cancer

Perioperative enfortumab vedotin plus pembrolizumab and surgery lead to significantly better outcomes among patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy compared with surgery alone, according to a study published online Feb. 18 in the New England Journal of Medicine.

Christof Vulsteke, M.D., Ph.D., from Antwerp University in Belgium, and colleagues assessed whether perioperative therapy may improve outcomes among patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy. The analysis included 344 participants randomly assigned to perioperative (neoadjuvant and adjuvant) enfortumab vedotin-pembrolizumab (170 patients) or surgery alone (control; 174 patients).

The researchers found that at two years, estimated event-free survival was 74.7% in the enfortumab vedotin-pembrolizumab group versus 39.4% in the control group (hazard ratio for an event or death, 0.40). Estimated overall survival was 79.7% and 63.1% respectively (hazard ratio for death, 0.50). A pathological complete response was achieved in 57.1% in the enfortumab vedotin-pembrolizumab group and 8.6% in the control group. All participants in the enfortumab vedotin-pembrolizumab group experienced adverse events (grade ?3, 71.3%; grade ?3 drug-related, 45.5%), as did 64.8% of patients in the control group (grade ?3, 45.9%).

“On the basis of this trial, the Food and Drug Administration approved neoadjuvant followed by adjuvant enfortumab vedotin plus pembrolizumab after cystectomy as a new treatment option for adults with muscle-invasive bladder cancer who are ineligible for cisplatin,” the authors write.

Several authors disclosed ties to pharmaceutical companies, including Merck Sharp and Dohme, which manufactures pembrolizumab and funded the study.

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