In the Phase III innovaTV 301 trial in recurrent or metastatic cervical cancer patients with disease progression on or after front-line therapy, Tivdak (tisotumab vedotin-tftv), compared with chemotherapy alone, met its primary endpoint of overall survival (OS).
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.
Tivdak (tisotumab vedotin) is an antibody-drug conjugate (ADC) composed of Genmab’s human monoclonal antibody directed to tissue factor and Seagen’s ADC technology that utilises a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody.
Subject to discussions with regulatory authorities, the results from innovaTV 301 are intended to serve as the pivotal confirmatory trial for US accelerated approval and support global regulatory applications. The innovaTV 301 China extension study has been initiated and continues to enrol patients, in collaboration with Zai Lab Limited.
“Tivdak is the only US Food and Drug Administration-approved therapy in second-line recurrent or metastatic cervical cancer regardless of biomarker status, tumour histology and prior therapy,” said Roger Dansey, President of Research and Development and Chief Medical Officer at Seagen. “Demonstrating a survival benefit with the results of innovaTV 301 is a critical milestone in our efforts to ensure more adults living with advanced cervical cancer have an approved treatment option.”
“With limited options for advanced cervical cancer patients who have progressed after front-line therapy, there is a need for therapeutic options with new mechanisms of action, particularly those with a demonstrated survival benefit,” added Jan van de Winkel, Chief Executive Officer at Genmab. “These results provide hope for patients with recurrent or metastatic cervical cancer.”