On April 29, 2024, the United States Food and Drug Administration (FDA) granted approval to Tivdak® (tisotumab vedotin-tftv) for recurrent or metastatic cervical cancer with disease progression following chemotherapy. This study was conducted by Seagen, which was acquired by Pfizer in December 2023.

The approval was based on the results of the global, randomized, Phase 3 innovaTV 301 clinical trial. This trial successfully met its primary endpoint by demonstrating an overall survival  benefit in adult patients with previously treated recurrent or metastatic cervical cancer who were treated with Tivdak compared to chemotherapy. Secondary endpoints of progression-free survival and confirmed objective response rate were also achieved. Notably, in October 2023, the results of the innovaTV 301 study were presented at the European Society of Medical Oncology (ESMO) Congress.

Recurrent or metastatic cervical cancer is a challenging and often incurable disease. Recognizing the urgent need for advancements in this area and in honor of Cervical Health and Cancer Screening Awareness 2025, we take a further look at the innovaTV 301 Phase III trial. Here is a brief overview of the study:

Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer (innovaTV 301)

Study Details | Source

  • Sponsor: Seagen Inc.
  • This trial is being done to find out whether tisotumab vedotin works better than chemotherapy to treat cervical cancer. People in this study have cervical cancer that has spread to other parts of the body (metastatic) or has come back after being treated (recurrent).
  • Participants in this trial will be randomly assigned to one of two groups. One group will be treated with tisotumab vedotin. Participants in the other group will get one of five different chemotherapy drugs (topotecan, vinorelbine, gemcitabine, pemetrexed, or irinotecan). Participants and their doctors will know which group they are in. Participants in the chemotherapy group will decide with their study doctor which drug they will take.
  • Interventions:
    • DruDrug: tisotumab vedotin
    • Drug: topotecan
    • Drug: vinorelbine
    • Drug: gemcitabine
    • Drug: irinotecan
    • Drug: pemetrexedg: DS-1062a
  • Primary Outcomes Measures:
    • Overall Survival
      • Overall survival is defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive.
      • From randomization to date of death due to any cause or censoring date, whichever occurred first (maximum up to 25 months)

The innovaTV 301 study revealed a 30% decrease in the risk of death compared to chemotherapy. Patients treated with Tivdak experienced a median overall survival of 11.5 months, surpassing the 9.5 months observed with chemotherapy. The safety profile of Tivdak in the innovaTV 301 study remained consistent with its established safety record outlined in the US prescribing information, with no new safety concerns identified.

This approval signifies the potential for this treatment to significantly influence future guidelines and clinical practices within the field. We highly value your input and welcome any thoughts or insights you may have on this topic. Additionally, we encourage you to sign up for alerts to stay informed on the latest published guidelines and articles. Thank you for your continued support and engagement in advancing medical research and treatment options.

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