Genmab : Phase 3 Trial Of TIVDAK In Recurrent Or Metastatic Cervical Cancer Meets Primary Endpoint

(RTTNews) - Genmab A/S (GMAB) and Seagen Inc. (SGEN) said that the Phase 3 innovaTV 301 global trial in recurrent or metastatic cervical cancer patients with disease progression on or after front-line therapy who received TIVDAK (tisotumab vedotin-tftv), compared with chemotherapy alone, met its primary endpoint of overall survival.

An Independent Data Monitoring Committee determined that overall survival crossed the pre-specified efficacy boundary at interim analysis.

According to the companies, the key secondary endpoints of investigator-assessed progression-free survival and objective response rate also demonstrated statistical significance. The safety profile of TIVDAK in innovaTV 301 is consistent with the known safety profile of TIVDAK as presented in the U.S. prescribing information, and no new safety signals were observed.

The companies noted that results of the Phase 3 innovaTV 301 clinical trial will be submitted for presentation at an upcoming medical congress and discussed with regulatory authorities.

TIVDAK is indicated in the U.S. for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

The indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

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