Treatment with Tivdak (tisotumab vedotin) has been shown to reduce the rate of death by 30% in patients with metastatic or recurrent cervical cancer, compared with chemotherapy, an expert said.
Tivdak is a type of monoclonal antibody that prevents the growth of new blood vessels that tumors need to live, defined by the National Cancer Institute.
In a phase 3 trial, called innovaTV 301, patients with metastatic or recurrent cervical cancer were randomly assigned to two groups: Tivdak or chemotherapy chosen by researchers, according to a listing from ClinicalTrials.gov.
The purpose of the phase 3 trial was to determine the overall survival (OS; time patients live before death of any cause), the listing stated.
A secondary endpoint — a result measured at the end of a study to see if treatment worked, the National Cancer Institute defines — was progression-free survival (PFS; time during and after treatment when patients live with cancer without worsening), the listed also reported.
“Progression-free survival was aligned with the overall survival findings, that there was a significant benefit in those patients receiving [Tivdak], with a 33% reduction,” Dr. Brian Slomovitz told CURE® at the SGO Annual Meeting on Women’s Cancer.
Slomovitz is the director of gynecologic oncology and co-chair of the cancer research committee at Mount Sinai Medical Center in Miami Beach, Florida.
Tivdak was approved by the Food and Drug Administration (FDA) in late 2021 for patients with metastatic or recurrent cervical cancer who experienced disease progression (worsening or spreading) after treatment with chemotherapy.
He noted that the trial demonstrated “game-changing results,” which now makes Tivdak a “good option” as second- or third-line treatment for this patient population.
Slomovitz spoke with CURE® about what a full approval of Tivdak as second- or third-line treatment for patients would look like.
Transcript:
So right now, we have an accelerated approval and you’re in the clinics, we’re using it. And we find that for some patients, it’s very, very beneficial.
Full approval will not only lead to widespread use in the US, but it’ll be the next step for global approval. Cervical cancer is a worldwide disease. We need better treatments globally. And with the full regulatory approval here, that will translate into approvals throughout the world.
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