Seattle Genetics announced dosing of the first patient in the phase 2 innovaTV 204 clinical trial evaluating the efficacy, safety and tolerability of tisotumab vedotin as monotherapy for patients with recurrent and/or metastatic cervical cancer who have relapsed or progressed after standard of care treatment. Tisotumab vedotin is being developed in collaboration with Genmab A/S. The innovaTV 204 trial is intended to support potential registration under the U.S. Food and Drug Administration’s (FDA) accelerated approval regulations. Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) designed to target Tissue Factor antigen on cancer cell surfaces and deliver the cell-killing agent monomethyl auristatin E (MMAE) directly inside cancer cells. The Tissue Factor antigen target is overexpressed in the vast majority of patients with cervical cancer and in many other solid tumors, including ovarian, lung, pancreatic, colorectal and head and neck.
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“While significant advances have been made in the treatment and prevention of cervical cancer, there remains a need for targeted agents that are effective for patients who progress or relapse after standard treatments,” said Robert Coleman, M.D., FACOG, FACS, Professor of Gynecologic Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX and principal investigator of the innovaTV 204 trial. “In a prior study, tisotumab vedotin demonstrated encouraging results in previously treated recurrent and/or metastatic cervical cancer, an area of unmet need where there is no established standard of care and response rates are limited.”
The phase 2 innovaTV 204 study (also known as GCT1015-04) is a global, multicenter, single arm trial that will enroll approximately 100 patients with recurrent and/or metastatic (2nd and 3rd line) cervical cancer who progressed on or relapsed after treatment with platinum-based chemotherapy used alone or in combination with bevacizumab (Avastin). Patients will be treated with single-agent tisotumab vedotin every three weeks. The primary endpoint of the trial is objective response rate as assessed by independent review. Key secondary endpoints include duration of response, progression-free survival, overall survival, safety and tolerability.
The companies also plan to evaluate tisotumab vedotin in multiple solid tumors in a phase 2 trial this year.