Enfortumab vedotin plus pembrolizumab approved in Europe for urothelial carcinoma

CAR-T Digest - August 2020

28 Aug 2024: Enfortumab vedotin plus pembrolizumab approved in Europe for urothelial carcinoma

The European Commission (EC) has approved the combination of enfortumab vedotin-ejfv (EV, Padcev) and pembrolizumab (Keytruda) for the first-line treatment of patients with unresectable or metastatic urothelial carcinoma who are eligible for platinum-based chemotherapy
The approval is based on findings from the first interim analysis of the phase 3 EV-302 trial (NCT04223856)
At a median follow-up of 17.2 months, treatment with EV plus pembrolizumab reduced the rate of death by 53% vs chemotherapy. Patients in the combination arm demonstrated a median OS of 31.5 months compared with 16.1 months among patients treated with chemotherapy (HR, 0.47; 95% CI, 0.38 to 0.58; P< .001)
Additionally, the median PFS was 12.5 months with EV/pembrolizumab vs 6.3 months with chemotherapy
The EV-302 trial remains ongoing to assess long-term outcomes. Final completion of the trial is anticipated for November 2027