|The following article features coverage from the Society of Gynecologic Oncology’s 50th Annual Meeting on Women’s Cancer. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
Tisotumab vedotin, a tissue factor-specific antibody-drug conjugate, was associated with manageable safety and antitumor activity in a cohort of patients with pretreated recurrent/metastatic cervical cancer enrolled in the phase 1/2 InnovaTV 201 trial (ClinicalTrials.gov Identifier: NCT02001623). The findings from this study were presented at the Society of Gynecologic Oncology (SGO)’s 50th Annual Meeting on Women’s Cancer.
Tissue factor, an important member of the human coagulation factor family, is highly expressed in cervical cancer. Furthermore, tumor expression of tissue factor has been associated with a poor prognosis in patients with this disease.
Tisotumab vedotin is an investigational drug composed of a human monoclonal antibody that binds to tissue factor, and is attached to a protease cleavable linker that is bound to a microtubule disrupting agent. Researchers sought to investigate tisotumab vedotin in patients with advanced solid tumors at a dose 2 mg/kg every 3 weeks until disease progression, toxicity, or withdrawal.
Safety and efficacy of tisotumab vedotin were evaluated for the first 34 patients enrolled in the cervical cancer cohort.
At data cutoff (May 2018), conjunctivitis, epistaxis, fatigue, alopecia, and nausea were the most commonly reported adverse events. The overall response rate, as assessed by the investigators using RECIST v1.1 criteria, was 32% and the median duration of response in patients with a confirmed response was 5.5 months. Patients who acheived response included heavily pretreated women and those refractory to other treatments.
A complete report that includes the full cohort of 55 women with cervical cancer enrolled in this study is forthcoming.
Read more of Cancer Therapy Advisor‘s coverage of SGO’s annual meeting by visiting the conference page.
- Hong DS, Arkenau HT, de Bono J, et al. Tisotumab vedotin (TV) in patients with previously treated recurrent or metastatic cervical cancer: updated safety and efficacy results from the full cervical cohort of the phase II Innova TV 201 study (NCT02001623). Presented at: The Society of Gynecologic Oncology (SGO)’s 50th Annual Meeting on Women’s Cancer; Honolulu, Hawaii; March 16-19, 2019. Abstract 19.