According to updated results from the phase 2 innovaTV 207 trial, tisotumab vedotin showed promising clinical activity among heavily pretreated patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). 

These data were presented by Lova Sun, MD, University of Pennsylvania, Philadelphia, Pennsylvania, at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.

The innovaTV 207 study is ongoing with Part C data still evolving, and the overall trial is evaluating the use of tisotumab vedotin, a tissue factor-directed antibody drug conjugate, in other head and neck cancer indications, both as a monotherapy and in combinations with immunotherapy and chemotherapy. Tisotumab vedotin is already approved for the treatment of patients with previously treated recurrent/metastatic cervical cancer and has shown encouraging activity in recurrent/metastatic head and neck squamous cell carcinoma.

In cohort C of the open-label, global, multi-cohort, multicenter phase 2 trial, 40 patients with recurrent or metastatic head and neck squamous cell carcinoma received 1.7 mg/kg of intravenous tisotumab vedotin once every 2 weeks. All patients had previously received a platinum-based regimen in the recurrent or metastatic setting, or had persistent disease following platinum-based chemoradiation and a checkpoint inhibitor. The primary end point was confirmed objective response rate (ORR). Secondary end points included duration of response (DOR), time-to-response, and safety. 

At analysis, confirmed ORR was 32.5% with 1 complete response and 12 partial responses. Median DOR was 5.6 months and median time-to-response was 1.4 months. Among patients who underwent ≤2 prior lines of therapy (n = 25) confirmed ORR was 40%. Among those patients, DOR data was immature at analysis and median time-to-response was 1.5 months. In the full cohort, 85% of patients experienced at least 1 treatment-related adverse event. Grade ≥3 treatment-related adverse events occurred in 25% of patients and were most frequently peripheral neuropathy-related (25%). 

Dr Sun concluded, “Tisotumab vedotin has potential for treatment of patients with [recurrent/metastatic] HNSCC that has progressed following immunotherapy and platinum-based chemotherapy.”

Source: 

Sun L, Fayette J, Salas S, et al. Tisotumab vedotin in head and neck squamous cell carcinoma: Updated analysis from innovaTV 207 part c. Presented at the ASCO Annual Meeting. May 31 – June 4, 2024; Chicago, IL. Abstract #6012