Merck’s KEYTRUDA plus Padcev approved by European Commission for perioperative treatment of resectable MIBC
- European Commission approved KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin‑ejfv) as neoadjuvant then adjuvant treatment for adults with resectable MIBC, covering EU27, Iceland, Liechtenstein and Norway.
- Phase 3 KEYNOTE‑B15 randomized 808 patients and showed a 47% reduction in event‑free survival events (HR=0.53) versus neoadjuvant gemcitabine‑cisplatin.
- Overall survival improved with a 35% reduced risk of death (HR=0.65) and pathologic complete response rates were 55.8% versus 32.5% for the combination versus chemotherapy.
- Approval follows a CHMP positive recommendation in September 2026 and a prior U.S. FDA approval in July 2026.
Approval and scope
The European Commission authorized KEYTRUDA (pembrolizumab) in combination with Padcev (enfortumab vedotin‑ejfv) as perioperative treatment — neoadjuvant followed by adjuvant after radical cystectomy — for adults with resectable muscle‑invasive bladder cancer (MIBC). The marketing authorization covers all 27 EU member states, Iceland, Liechtenstein and Norway; national reimbursement processes will determine timing of commercial availability.
KEYNOTE‑B15 efficacy
Approval was based on Phase 3 KEYNOTE‑B15 (EV‑304). In 808 randomized, previously untreated cisplatin‑eligible patients, the combination reduced the risk of event‑free survival (EFS) events by 47% (HR=0.53; 87/405 versus 146/403) and reduced risk of death by 35% (HR=0.65; 69/405 versus 99/403) compared with neoadjuvant gemcitabine‑cisplatin and surgery. Pathologic complete response (pCR) was 55.8% versus 32.5% (p<0.0001).
Trial design and regimen
KEYNOTE‑B15 randomized patients 1:1 (n=808) to four cycles of neoadjuvant KEYTRUDA 200 mg IV Day 1 plus Padcev 1.25 mg/kg IV Days 1 and 8 every 21 days prior to surgery, followed by specified adjuvant KEYTRUDA and Padcev cycles, or to four cycles of neoadjuvant gemcitabine plus cisplatin followed by observation.
Regulatory context
The EC decision follows a CHMP positive opinion in September 2026 and a U.S. FDA approval of the same regimen in July 2026; the study was conducted in collaboration with Pfizer and Astellas (Padcev originally developed by Seagen, acquired by Pfizer).
Source: Merck