Eligible patients with advanced-stage urothelial carcinoma (UC) typically receive platinum-based chemotherapy as first-line therapy, with median overall survival (OS) durations of ~15 months. Now, data from the phase III EV-302 trial demonstrate the superior efficacy of the antibody–drug conjugate enfortumab vedotin (EV) plus the anti-PD-1 antibody pembrolizumab in this setting.

A total of 886 patients with unresectable locally advanced or metastatic UC requiring first-line therapy or with disease recurrence >12 months after completion of neoadjuvant or adjuvant systemic therapy were randomly assigned (1:1) to receive EV plus pembrolizumab or platinum-based chemotherapy (gemcitabine plus either cisplatin or, for cisplatin-ineligible patients, carboplatin). Progression-free survival (PFS) and OS were the co-primary end points.