FDA Expands Bladder Cancer Regimen

KEYNOTE-B15/EV-304 demonstrated statistically significant improvements in event-free and overall survival with perioperative pembrolizumab plus enfortumab vedotin-ejfv compared with neoadjuvant gemcitabine plus cisplatin.

By
Kathryn Wighton
July 10, 2026
2 min

MDSpire News

Objective:

To approve new treatment options for adults with muscle-invasive bladder cancer who are candidates for cystectomy.

Approach:

Study Design: The KEYNOTE-B15/EV-304 trial was an open-label, randomized, active-controlled, multicenter study involving 808 patients with previously untreated muscle-invasive bladder cancer.
Treatment Groups: Patients were assigned to receive either neoadjuvant pembrolizumab plus enfortumab vedotin-ejfv followed by surgery and adjuvant treatment or neoadjuvant gemcitabine plus cisplatin followed by surgery.

Key Findings:

The FDA approved pembrolizumab or pembrolizumab with enfortumab vedotin-ejfv for neoadjuvant and adjuvant treatment.
The approval expands the indication to all adults with muscle-invasive bladder cancer eligible for cystectomy.
Median event-free survival was not reached in the pembrolizumab group and was 48.5 months in the gemcitabine plus cisplatin group.
Median overall survival was not reached in either treatment group.