Tivdak improved overall survival in patients with recurrent or metastatic cervical cancer, compared with chemotherapy alone.
The treatment of Tivdak (tisotumab vedotin-tftv) for patients with recurrent or metastatic cervical cancer has been shown to improve overall survival, according to preliminary data from a phase 3 trial.
According to National Cancer Institute, Tivdak is a drug that is used for patients with cervical cancer that has either come back (recurrent) or spread (metastatic) and is injected into a vein. The drug is also used for patients whose cancer worsened during or after chemotherapy. Tivdak contains a monoclonal antibody that binds onto a protein that is found on some cancer cells, called tissue factor, and works to kill these cancer cells, as reported from National Cancer Institute.
Tivdak was approved by the U.S. Food and Drug Administration in September 2021 for patients who were previously treated for recurrent or metastatic cervical cancer that progressed after chemotherapy.
Recurrent or metastatic cervical cancer is known to be an incurable disease with highly unmet needs, according to a press release from Seagen and Genmab, the manufacturers of Tivdak.
The phase 3 trial, innovaTV 301, has a total of 502 patient-participants with recurrent or metastatic cervical cancer who received two or less prior lines of treatment while they had recurrent or metastatic cervical cancer. The trial is evaluating the use of Tivdak compared with the use of chemotherapy alone.
The innovaTV 301 trial recently met its primary endpoint (a main result that measures a treatment’s efficacy in a study), which was overall survival (OS), the period from diagnosis or treatment where patients are still alive. According to the press release, an Independent Data Monitoring Committee confirmed that the overall survival surpassed the pre-specified efficacy boundary at interim analysis (analyzing data before the completion of data collection).
The trial also found that their secondary endpoints — progression-free survival and objective response rate — both achieved statistical significance, as reported in the press release.
“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,” said Dr. 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.”
Regarding the safety profile of Tivdak in the innovaTV 301 trial, the press release stated that it remained consistent with the known safety profile from the U.S. prescribing information and also determined that no new safety signals were observed.
Tivdak included a box warning of ocular toxicity, which is when a drug may affect the structure or function of the eye. Specifically, Tivdak may cause changes in the corneal epithelium (the cornea’s outermost layer) and conjunctiva (a membrane that lines the eyelid and covers the tough white part of the eye), which can cause changes in vision.
The press release also reported that serious side effects occurred in 43% of general patients who receive Tivdak. Common serious side effects less than or equal to 3% included ileus (painful obstruction of the bowel), constipation, pneumonia, hemorrhage and fever.
“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,” said Jan van de Winkel, chief executive officer of Genmab. “These results provide hope for patients with recurrent or metastatic cervical cancer.”
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