The OS in the Phase 3 trial crossed the pre-specified efficacy limit at interim analysis and investigator-assessed progression-free survival and objective response rate also showed statistical significance
Tivdak delivered positive results in the Phase 3 cervical cancer trial innovaTV 301. (Credit: Tatiana from Pixabay)
Seagen and Genmab announced that Tivdak (tisotumab vedotin-tftv) met its primary endpoint of overall survival (OS) in the Phase 3 innovaTV 301 trial in recurrent or metastatic cervical cancer patients.
Tivdak is an antibody-drug conjugate (ADC), which is made up of Genmab’s human monoclonal antibody directed to tissue factor (TF) and the ADC technology of Seagen. The latter is being acquired by Pfizer in a $43bn deal, which is subject to meeting certain conditions like regulatory approvals.
In late 2021, the drug was given accelerated approval by the US Food and Drug Administration (FDA) in adults with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
The innovaTV trial evaluated the ADC in 502 cervical cancer patients whose disease advanced on or after front-line therapy. The drug candidate was compared with chemotherapy alone in the late-stage trial.
According to an independent data monitoring committee, the OS in the Phase 3 trial crossed the pre-specified efficacy limit at interim analysis.
Investigator-assessed progression-free survival and objective response rate, two key secondary endpoints of the trial, also showed statistical significance.
There were no new safety signals noticed, and the Tivdak safety profile in the late-stage trial was in line with the known safety profile of the drug candidate as described in the US prescribing information.
Seagen chief medical officer and research and development president Roger Dansey said: “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.
“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.”
The other secondary endpoints of the trial included time to response and duration of response among others.
Genmab CEO Jan van de Winkel said: “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.”
The findings of the innovaTV 301 study will be used for supporting global regulatory applications. The trial is intended to serve as the primary confirmatory study for the US accelerated approval.
The innovaTV 301 China extension trial has begun and is still enrolling patients in partnership with Zai Lab.