ASCO 2023 | EV-103: EV + pembrolizumab as a promising first-line option for urothelial carcinoma

Shilpa Gupta, MD, Cleveland Clinic, Cleveland, OH, explores the potential of enfortumab vedotin (EV) and pembrolizumab combination therapy as a first-line treatment for cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma (la/mUC). In the EV-103 Phase Ib/II (NCT03288545) study, patients received EV and pembrolizumab in 3-week cycles. The study’s primary endpoint was safety/tolerability, with secondary endpoints including confirmed overall response rate (cORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS). After almost 4 years of follow-up, the combination demonstrated favorable results. The cORR was 73.3%, with a DCR of 84.4%. Median DOR was 22.1 months, median PFS was 12.7 months, and median OS was 26.1 months. Common treatment-related adverse events for EV included skin reactions, peripheral neuropathy, and ocular disorders, while pembrolizumab was associated with severe skin reactions, pneumonitis, colitis, and hypothyroidism. The combination’s safety profile remained stable over time, and subsequent therapy data were presented. The study supports further evaluation of EV plus pembrolizumab in ongoing Phase III trials for urothelial carcinoma.This interview took place at the American Society of Clinical Oncology (ASCO) 2023 Annual Congress in Chicago, IL.

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