The innovaTV 301 Trial for Patients with Cervical Cancer

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The innovaTV 301 trial highlights a promising treatment for recurrent or metastatic cervical cancer.

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In this video, discover how Tisotumab vedotin significantly improves survival rates and reduces severe side effects compared to standard chemotherapy.

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‍Read the full video transcript below:

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This video is an overview of a global clinical trial called the innovaTV 301 trial.

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The results of this trial show that treating recurrent or metastatic cervical cancer   significantly lowers the risk of death compared to standard chemotherapy.

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Cervical cancer is a type of cancer that starts in the cervix, a circular organ that connects the uterus to the vagina. When cervical cancer spreads to other parts of the body, it is called metastatic. If it comes back after treatment, it is called recurrent cervical cancer.

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In InnovaTV 301 study, 502 participants with recurrent or metastatic cervical cancer were randomly assigned to one of two groups. One group was treated with tisotumab vedotin, while the other group received chemotherapy. Participants and their doctors knew which treatment they were receiving, and those in the chemotherapy group decided with their doctor which drug to take.

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The trial found that tisotumab vedotin led to a 30% reduction in the risk of death compared to chemotherapy. The median overall survival was 11.5 months for the tisotumab vedotin group compared to 9.5 months for the chemotherapy group. After 12 months, 48.7% of patients treated with tisotumab vedotin were still alive, compared to 35.3% of those treated with chemotherapy.

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Progression-free survival, which measures the time during and after treatment that a patient lives with the disease without it getting worse, was also better with tisotumab vedotin. The median progression-free survival was 4.2 months with tisotumab vedotin, compared to 2.9 months with chemotherapy, resulting in a 33% reduction in the risk of the cancer worsening.

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The study also showed that the response rate was significantly higher with tisotumab vedotin, with 17.8% of patients showing tumor shrinkage, compared to 5.2% in the chemotherapy group.

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Side effects with tisotumab vedotin were generally low-grade and manageable. Fewer patients experienced severe side effects (grade 3 or higher) with tisotumab vedotin (29.2%) compared to chemotherapy (45.2%). The most common severe side effects with tisotumab vedotin included peripheral neuropathy (5.2%), eye problems (3.2%), and bleeding (0.8%). Treatment-related deaths were rare, with two in the tisotumab vedotin group and one in the chemotherapy group.

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The findings of this trial suggest that tisotumab vedotin provides a significant improvement in survival and disease control compared to standard chemotherapy, offering new hope for patients with this challenging condition.

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These results prompted accelerated FDA approval in 2021 and full FDA approval in 2024.

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This video is for educational purposes only. Talk to your doctor before making any medical decisions. This is not medical advice.