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KEYNOTE-B15/EV-304

Enfortumab Vedotin and Pembrolizumab in Cisplatin-Eligible Bladder Cancer

Phase 3N = 808NCT04700124

Population
Adults with muscle-invasive bladder cancer eligible for cisplatin-based chemotherapy and radical cystectomy with pelvic lymph-node dissection
Design
Phase 3, open-label randomised trial in adults with muscle-invasive bladder cancer eligible for cisplatin-based chemotherapy and radical cystectomy with pelvic lymph-node dissection: four neoadjuvant cycles of enfortumab vedotin plus pembrolizumab every 3 weeks, cystectomy, then five cycles of enfortumab vedotin and 13 cycles of pembrolizumab as adjuvant therapy; or four neoadjuvant cycles of cisplatin-gemcitabine every 3 weeks followed by cystectomy. Primary end point event-free survival; key secondary end points overall survival and pathological complete response.
Primary endpoint
EFS
Arms
  • Enfortumab vedotin plus pembrolizumab (experimental, n = 405): Neoadjuvant enfortumab vedotin 1.25 mg per kilogram on days 1 and 8 plus pembrolizumab 200 mg on day 1 every 3 weeks for 4 cycles, cystectomy, then 5 cycles of enfortumab vedotin and 13 cycles of pembrolizumab
  • Cisplatin-gemcitabine (control, n = 403): Neoadjuvant cisplatin 70 mg per square meter on day 1 plus gemcitabine 1000 mg per square meter on days 1 and 8 every 3 weeks for 4 cycles, then cystectomy
People
Galsky MD, senior author Gómez de Liaño A, KEYNOTE-B15/EV-304 Investigators
EFSHR 0.53 (95% CI 0.41–0.70)Δ 24-month EFS+13.2 pointsOSHR 0.65 (95% CI 0.48–0.89)Δ 24-month OS+5.6 pointsΔ pCR+23.3 points
Show the numbers
Results reported for KEYNOTE-B15/EV-304
EndpointAnalysisEnfortumab vedotin plus pembrolizumabCisplatin-gemcitabineEffect
EFSRandomised patients (analysis population not stated in the abstract)primaryGalsky 202679.4% at 2 y66.2% at 2 yHR 0.53 (95% CI 0.41–0.70)P<0.001Median time from randomization to the data-cutoff date 33.6 months (range 22.5 to 53.6).
OSRandomised patients (analysis population not stated in the abstract)primaryGalsky 202686.9% at 2 y81.3% at 2 yHR 0.65 (95% CI 0.48–0.89)P=0.006 (two-sided)Overall survival was a key secondary end point.
pCRRandomised patients (analysis population not stated in the abstract)primaryGalsky 202655.8%32.5%P<0.001Key secondary end point.
Results reported for KEYNOTE-B15/EV-304
EndpointAnalysisEnfortumab vedotin plus pembrolizumabCisplatin-gemcitabineEffect
EFSRandomised patients (analysis population not stated in the abstract)primaryGalsky 202679.4% at 2 y66.2% at 2 yHR 0.53 (95% CI 0.41–0.70)P<0.001Median time from randomization to the data-cutoff date 33.6 months (range 22.5 to 53.6).
OSRandomised patients (analysis population not stated in the abstract)primaryGalsky 202686.9% at 2 y81.3% at 2 yHR 0.65 (95% CI 0.48–0.89)P=0.006 (two-sided)Overall survival was a key secondary end point.
pCRRandomised patients (analysis population not stated in the abstract)primaryGalsky 202655.8%32.5%P<0.001Key secondary end point.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
EFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
EFS0.530.41–0.7
OS0.650.48–0.89
Primary publication: Galsky MD, Valderrama BP, Maruzzo M, Font A, Ciuleanu T, Chatzkel J, et al. Enfortumab Vedotin and Pembrolizumab in Cisplatin-Eligible Bladder Cancer. N Engl J Med. 2026;395(4):338-348. PubMedDOI

Appears in

Sources

  1. Galsky MD, Valderrama BP, Maruzzo M, Font A, Ciuleanu T, Chatzkel J, et al. Enfortumab Vedotin and Pembrolizumab in Cisplatin-Eligible Bladder Cancer. N Engl J Med. 2026;395(4):338-348.

    PubMedDOI