Key Findings
The European Commission (EC) approved pembrolizumab (Keytruda) plus enfortumab vedotin (Padcev) for use as neoadjuvant treatment followed by adjuvant treatment after radical cystectomy in adult patients with resectable muscle-invasive bladder cancer (MIBC). This approval applies regardless of cisplatin eligibility and includes pembrolizumab and berahyaluronidase alfa (Keytruda Qlex).
In the phase 3 KEYNOTE-B15/EV-304 trial, the combination demonstrated a 2-year event-free survival (EFS) rate of 79.4% versus 66.2% for neoadjuvant gemcitabine plus cisplatin (HR, 0.53; P < .0001). The estimated 2-year overall survival (OS) rate was 86.9% for the combination compared to 81.3% for chemotherapy (HR, 0.65; P = .006). Pathologic complete response (pCR) was achieved in 55.8% of the combination group versus 32.5% in the chemotherapy group (P < .001).
Technical Details
The trial enrolled 808 adults with previously untreated MIBC (clinical T2-T4aN0M0 or T1-T4aN1M0) who were candidates for cisplatin and radical cystectomy. The treatment regimen for the investigational arm consisted of:
- Neoadjuvant: 4 cycles of intravenous pembrolizumab (200 mg on day 1) and enfortumab vedotin (1.25 mg/kg on days 1 and 8).
- Adjuvant: 5 cycles of enfortumab vedotin and 13 cycles of pembrolizumab following surgery.
Grade 3 or higher adverse effects (AEs) occurred in 75.7% of the combination arm versus 67.2% in the chemotherapy arm. Common reactions for the combination included rash (63%), fatigue (48%), pruritus (46%), and peripheral neuropathy (43%).
Background and Context
Cisplatin-based chemotherapy has long been the standard for MIBC, but recurrence remains a significant challenge. The FDA previously approved this combination in July 2026 for neoadjuvant and adjuvant therapy, expanding a prior indication that was limited to cisplatin-ineligible patients.
Significance and Outlook
This approval provides a meaningful advance by extending a chemotherapy-free perioperative treatment option to a broader patient population in the European Union, regardless of their ability to tolerate cisplatin.
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