Tisotumab vedotin (TV) may be an alternative treatment for squamous cell carcinoma of the head and neck (SCCHN) that has progressed after treatment with platinum chemotherapy and a checkpoint inhibitor, according to researchers.
Preliminary data presented at the 2022 Multidisciplinary Head and Neck Cancers Symposium suggest TV has antitumor activity and a manageable safety profile in patients with SCCHN.
“The data we presented are very encouraging in head and neck cancer,” study author David S. Hong MD, of the University of Texas MD Anderson Cancer Center in Houston, said in an interview.
“It suggests that, in earlier-line settings, TV may have clear clinical benefit, and we are hopeful that, in combinations, TV will have even more effectiveness.”
Dr Hong and colleagues are testing TV in the phase 2 innovaTV 207 trial (ClinicalTrials.gov Identifier: NCT03485209). The trial is enrolling patients with various solid tumors, including a cohort with SCCHN.
Data from 31 SCCHN patients were presented at the meeting. The patients had relapsed, locally advanced, or metastatic SCCHN. Their median age was 65 (range, 47-78) years, and 74.2% of patients were White.
The median number of prior therapies received was 2 (range, 1-5). The patients had received a platinum-based regimen and a checkpoint inhibitor or anti-EGFR therapy prior to study entry (if eligible). Patients were excluded if they had received more than 3 systemic regimens in the recurrent/metastatic setting.
The patients received TV at 2 mg/kg intravenously every 3 weeks. The median duration of treatment was 12 weeks (range, 3-36 weeks).
The objective response rate was 16.1%. All 5 responders had a partial response. The disease control rate was 58.1%, and 79% of evaluable patients had a reduction in the size of their target lesions.
The median progression-free survival was 4.2 months, and the median overall survival was 9.4 months.
The incidence of treatment-related adverse events (TRAEs) was 90.3%, and 38.7% of patients had grade 3 or higher TRAEs. There were no fatal TRAEs.
The most common TRAEs were nausea (29%), myalgia (29%), epistaxis (29%), fatigue (23%), dry eye (23%), decreased appetite (23%), and peripheral sensory neuropathy (23%).
Disclosures: This research was supported by Seagen Inc., in collaboration with Genmab. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Cho M, Hong DS, Birnbaum A, et al. Efficacy and safety of tisotumab vedotin in patients with head and neck squamous cell carcinoma: Results from a phase II cohort. Multidisciplinary Head and Neck Cancers Symposium 2022. February 24-26, 2022. Abstract 15.