In a phase II trial (EV-202) reported in the Journal of Clinical Oncology, Swiecicki et al found that the antibody-drug conjugate enfortumab vedotin showed activity in heavily pretreated patients with recurrent or metastatic head and neck cancer (HNC).
Study Details
In the study, 46 patients who had received platinum-based therapy for locally advanced or metastatic disease and a PD-1/PD-L1 inhibitor were enrolled from sites in Japan and North America. Patients received enfortumab vedotin at 1.25 mg/kg on days 1, 8, and 15 of each 28-day cycle, with treatment continued until disease progression, unacceptable toxicity, or initiation of a new anticancer therapy. A total of 52.2% of patients had received at least three previous lines of systemic therapy in the metastatic setting. The primary outcome measure was investigator-assessed objective response.
Key Findings
Median follow-up for response evaluation was 9.3 months. Objective responses were observed in 11 of 46 patients (23.9%, 95% confidence interval [CI] = 12.6%–38.8%), with complete response in 1. The disease control rate was 56.5%. Median duration of response was not reached. At a later data cutoff, with a median follow-up of 11.3 months, median duration of response was 9.4 months (95% CI = 2.5 months to not reached). Median progression-free survival was 3.9 months (95% CI = 2.8–4.7 months), and median overall survival was 6.0 months (95% CI = 4.4–10.7 months).
The most common treatment-related adverse events of any grade were alopecia (28.3%), fatigue (26.1%), and peripheral sensory neuropathy (23.9%). Grade ≥3 treatment-related adverse events occurred in 34.8% of patients, most commonly anemia (4.3%) and decreased neutrophils (4.3%). Death considered related to treatment occurred in two patients (unexplained death and colonic perforation).
The investigators concluded: “Enfortumab vedotin demonstrated antitumor activity in heavily pretreated HNC. Safety was consistent with the known safety profile of enfortumab vedotin; no new safety signals were identified. These data support further evaluation of enfortumab vedotin for advanced HNC not amenable to definitive local therapy.”
Paul L. Swiecicki, MD, of the University of Michigan Rogel Cancer Center, Ann Arbor, is the corresponding author of the Journal of Clinical Oncology article.
Disclosure: The study was reported by Astellas Pharma, Inc, and Seagen, which was acquired by Pfizer in December 2023. For full disclosures of all study authors, visit Journal of Clinical Oncology.
