EV-302: Long-term subgroup analysis from the phase 3 global study of enfortumab vedotin in combination with pembrolizumab (EV+P) vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC).
Abstract 4571 Background: EV-302/KEYNOTE-A39 (NCT04223856) demonstrated superior efficacy of first-line (1L) EV+P vs chemo and established EV+P as the standard of care (SOC). EV+P is included in global treatment guidelines for patients (pts) with untreated la/mUC. After ≈2.5 years of median follow-up, the benefit of EV+P was sustained; median OS was maintained for > 2.5 years. We present long-term efficacy and safety analyses in the following prespecified subgroups: primary disease site of origin (upper and lower tracts), lymph node (LN)–only disease, and presence of liver metastases (mets) (present and absent). Methods: Pts with previously untreated la/mUC were randomized 1:1 to receive EV (1.25 mg/kg; Days 1 and 8; IV) and P (200 mg; Day 1; IV) or chemo (gemcitabine with cisplatin or carboplatin) every 3 wk. Primary endpoints were progression-free survival (PFS) by blinded independent central review (BICR) and overall survival (OS). A genAI tool (01/09/25; Pfizer;...