On March 29, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) reported completion of enrollment in the potentially pivotal innovaTV 204 phase 2 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 (Press release, Seattle Genetics, MAR 29, 2019, View Source [SID1234534761]). 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 cells and deliver the cell-killing agent monomethyl auristatin E (MMAE) directly inside cancer cells. Tissue Factor is overexpressed in cervical cancer and many other solid tumors.
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"Cervical cancer is a devastating disease with a significant need to develop improved therapies for patients with metastatic disease who have progressed after treatment," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. "Completing enrollment in this potentially pivotal phase 2 trial marks an important step forward in evaluating tisotumab vedotin for women with previously treated recurrent and/or metastatic cervical cancer."
For more information about the phase 2 innovaTV 204 clinical trial and other clinical trials with tisotumab vedotin, please visit www.clinicaltrials.gov.
About innovaTV 204 Trial
The innovaTV 204 trial (also known as GCT1015-04) is an ongoing single-arm, global, multicenter study of tisotumab vedotin for patients with recurrent and/or metastatic cervical cancer who progressed on or relapsed after treatment with doublet chemotherapy used alone or in combination with bevacizumab (Avastin). The study enrolled over 100 patients at multiple centers. The primary endpoint of the trial is objective response rate as assessed by blinded independent central review. Key secondary endpoints include duration of response, progression-free survival, overall survival, safety and tolerability.