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.

符合条件的晚期尿路上皮癌 (UC) 患者通常接受铂类化疗作为一线治疗，中位总生存期 (OS) 约为 15 个月。现在，来自 III 期 EV-302 试验的数据证明了抗体药物偶联物 enfortumab vedotin (EV) 加上抗 PD-1 抗体 pembrolizumab 在此情况下的卓越功效。

总共 886 名患有不可切除的局部晚期或转移性 UC 需要一线治疗或完成新辅助或辅助全身治疗后 12 个月以上的疾病复发的患者被随机分配 (1:1) 接受 EV 加派姆单抗或铂类化疗（吉西他滨加顺铂，或者对于不适合顺铂的患者，加卡铂）。无进展生存期 (PFS) 和 OS 是共同主要终点。