Merck: EU approves pembrolizumab plus enfortumab vedotin for cisplatin‑ineligible resectable MIBC
- EU approval covers pembrolizumab plus enfortumab vedotin as neoadjuvant treatment and continued adjuvant therapy after radical cystectomy for cisplatin‑ineligible resectable MIBC.
- Phase 3 KEYNOTE‑905 (EV‑303) showed perioperative combination reduced risk of event‑free survival events by 60% versus surgery alone.
- The trial also showed a 50% reduction in risk of death with the combination versus surgery alone.
- KEYNOTE‑905 was conducted in collaboration with Pfizer and Astellas; approval includes KEYTRUDA SC (KEYTRUDA QLEX in the U.S.).
Regulatory approval
Merck’s KEYTRUDA (pembrolizumab) in combination with Padcev (enfortumab vedotin‑ejfv) is approved in the EU as neoadjuvant treatment and then continued as adjuvant therapy after radical cystectomy for adults with resectable muscle‑invasive bladder cancer who are ineligible for cisplatin‑containing chemotherapy. The approval makes this the first PD‑1 inhibitor plus antibody‑drug conjugate regimen available for these patients in the EU and also covers the subcutaneous formulation KEYTRUDA SC (known as KEYTRUDA QLEX in the U.S.).
Clinical evidence
The approval is based on results from the pivotal Phase 3 KEYNOTE‑905 trial (also known as EV‑303). Perioperative KEYTRUDA plus Padcev reduced the risk of event‑free survival events by 60% and reduced the risk of death by 50% versus surgery alone in the studied population.
Study context
KEYNOTE‑905 was conducted in collaboration with Pfizer and Astellas. The regimen is indicated specifically for adults with resectable disease who cannot receive cisplatin, delivered before surgery and continued after radical cystectomy according to the approved indication.
Source: Merck