Seagen Inc. (Nasdaq: SGEN) and Genmab A/S (Nasdaq: GMAB) have jointly announced the positive results from the Phase 3 innovaTV 301 global trial, which focused on recurrent or metastatic cervical cancer patients with disease progression after initial therapy. This trial compared the efficacy of TIVDAK® (tisotumab vedotin-tftv) with chemotherapy alone and successfully met its primary endpoint of overall survival (OS). An Independent Data Monitoring Committee found that OS surpassed the pre-specified efficacy boundary during interim analysis. The trial also demonstrated statistical significance in key secondary endpoints, including investigator-assessed progression-free survival and objective response rate. The safety profile of TIVDAK in this trial remained consistent with its known safety profile, with no new safety concerns identified.

These findings from innovaTV 301/ENGOT cx-12/GOG 3057, a global Phase 3 trial, build upon the results from innovaTV 204, which served as the basis for the accelerated approval of TIVDAK in the United States. Subject to discussions with regulatory authorities, the innovaTV 301 results are intended to serve as the pivotal confirmatory trial for the U.S. accelerated approval and support global regulatory applications. An extension study of innovaTV 301 is underway in China, in collaboration with Zai Lab Limited, to further enroll patients.

Roger Dansey, M.D., President of Research and Development and Chief Medical Officer at Seagen, highlighted the significance of these results: "TIVDAK is the only U.S. Food and Drug Administration-approved therapy in second-line recurrent or metastatic cervical cancer regardless of biomarker status, tumor histology and prior therapy. 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."

Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab, emphasized the importance of these findings for patients with advanced cervical cancer who have limited treatment options after initial therapy: "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."

Results from the Phase 3 innovaTV 301 clinical trial will be submitted for presentation at an upcoming medical congress and discussed with regulatory authorities.