Multicenter phase 2 trial of enfortumab vedotin in patients with previously treated advanced head and neck cancer

Unresectable recurrent/metastatic (R/M) head and neck cancer (HNC) carries a poor prognosis, and effective treatments are needed. As nectin- 4 is widely expressed in HNC, the nectin-4-directed antibody drug conjugate enfortumab vedotin (EV) was explored in the HNC cohort of the multicenter, multicohort phase 2 trial EV-202. The cohort included patients with R/M HNC who previously had received at least platinum-based therapy and a PD-(L)1 inhibitor; most patients (52.2%) had 3 or more previous lines of systemic therapy in the advanced setting. In EV-202, patients received EV 1.25 mg/kg on days 1, 8, and 15 of 28-day cycles. The primary end point was investigator-assessed objective response rate. The objective response rate and disease control rate were 23.9% and 56.5%, respectively, with a median duration of response 9.4 months. Median progression-free survival and overall survival were 3.9 months and 6.0 months, respectively. Safety was consistent with the known safety profile of EV. The authors conclude that EV demonstrated antitumor activity in heavily pretreated HNC.