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# Tivdak Confirmatory Trial Meets Primary Endpoint
- URL: https://www.fdaweb.com/tivdak-confirmatory-trial-meets-primary-endpoint/
- Published: 2023-09-05T12:00:00.000Z
- Updated: 2026-09-14T18:54:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155244

Seagen and Genmab’s cancer drug Tivdak (tisotumab vedotin-tftv) met its primary endpoint of overall survival in their confirmatory Phase 3 innovaTV 301 trial, the companies said 9/5\. The study was conducted in recurrent or metastatic cervical cancer patients with disease progression on or after front-line therapy, evaluating those who received Tivdak (tisotumab vedotin-tftv) compared with chemotherapy alone. “The key secondary endpoints of investigator-assessed progression-free survival and objective response rate also demonstrated statistical significance,” the companies say.

These results will be submitted to FDA to serve as the pivotal confirmatory trial to convert Tivdac’s 2021 accelerated approval for this indication to a traditional approval, Seagen and Genmab say. At that time, the accelerated approval was based on data showing a 24% confirmed objective response rate, and the median duration of response was 8.3 months.

Tidvak is an antibodydrug conjugate (ADC) comprising Genmab’s human monoclonal antibody directed to tissue factor (TF) and Seagen’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody, according to the companies. “Nonclinical data suggests that the anticancer activity of Tivdak is due to the binding of the ADC to TF expressing cancer cells, followed by internalization of the ADC-TF complex, and release of MMAE via proteolytic cleavage,” they say. “MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death.”