(UroToday.com) Cisplatin-based chemotherapy is the standard of care in first-line for metastatic urothelial carcinoma and is associated with an overall survival benefit. However, approximately half of patients with locally advanced or metastatic urothelial carcinoma in the US are cisplatin-ineligible. Cisplatin-ineligible, platinum-naive patients with locally advanced or metastatic urothelial carcinoma who progress on or after PD-1/L1 inhibitors have a poor prognosis and few treatment options. Enfortumab vedotin is an antibody-drug conjugate directed against Nectin-4, an immunoglobulin-like cell adhesion molecule highly expressed in urothelial carcinoma. Additionally, enfortumab vedotin has demonstrated a survival benefit in patients who have received both platinum-containing chemotherapy and immunotherapy.1 EV-201 (NCT03219333) is a pivotal, single-arm, 2-cohort study of enfortumab vedotin in locally advanced or metastatic urothelial carcinoma. Cohort 1 data led to FDA accelerated approval of enfortumab vedotin in adult patients with locally advanced or metastatic urothelial carcinoma who previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic urothelial carcinoma setting. At the 2021 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), Dr. Arjun Balar and colleagues presented results from the primary analysis of EV-201 cohort 2 comprising cisplatin-ineligible patients with prior PD-1/L1-inhibitor treatment and no prior platinum for locally advanced or metastatic urothelial carcinoma.