The following is a summary of “Phase II Trial of Enfortumab Vedotin in Patients With Previously Treated Advanced Head and Neck Cancer,” published in the October 2024 issue of Oncology by Swiecicki et al.  

Unresectable recurrent and metastatic head and neck cancer (HNC) has a poor prognosis, highlighting the urgent need for effective treatments.  

Researchers conducted a prospective study evaluating the efficacy and safety of enfortumab vedotin (EV) in patients with previously treated advanced HNC.  

They conducted an open-label, multicohort phase II study of intravenous EV (1.25 mg/kg) administered on days 1, 8, and 15 per 28-day cycle. Eligible patients had recurrent or metastatic HNC and had previously received platinum-based therapy for locally advanced/metastatic disease and a programmed cell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. The primary endpoint was the investigator-assessed verified objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, with secondary endpoints including duration of response (DOR), disease control rate (DCR), PFS, OS, and safety.  

The results showed that the primary analysis included 46 patients receiving EV (median follow-up, 9.3 months). Most patients (52.2%) had received 3 or more prior lines of systemic treatment in the metastatic stage, confirmed ORR was 23.9%, the DCR was 56.5%, and the median DOR was not reached (median DOR was 9.4 months at a later data cutoff [median follow-up, 11.3 months]). The median PFS was 3.9 months, and the median OS was 6.0 months. Treatment-related AEs (TRAEs) occurring in more than 20% of patients included alopecia (28.3%), fatigue (26.1%), and peripheral sensory neuropathy (23.9%), 16 patients (34.8%) experienced grade ≥3 TRAEs, including anemia and decreased neutrophil count, which occurred in 2 patients each (4.3%).  

They concluded that EV demonstrated antitumor activity and a tolerable safety profile in heavily pretreated patients with advanced HNC.  

Source: ascopubs.org/doi/10.1200/JCO.24.00646