New Phase III data on Seagen and Genmab's Tivdak

New Phase III innovaTV 301 global trial data 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 (OS), the drug’s developers, US biotech Seagen (Nasdaq: SGEN) and Denmark’s Genmab (OMX: GEN), announced late yesterday.

An Independent Data Monitoring Committee determined that OS crossed the pre-specified efficacy boundary at interim analysis. 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 was consistent with the known safety profile of Tivdak as presented in the US prescribing information, and no new safety signals were observed.

The results of innovaTV 301/ENGOT cx-12/GOG 3057, a global, randomized, open-label Phase III trial, add to the previous results of innovaTV 204, which served as the basis for the accelerated approval in September 2021 of Tivdak in the USA.