The Tivdak trial met its primary endpoint in September 2023. Credit: Carol Yepes via Getty Images.

Genmab and Seagen have reported additional positive results from the Phase III clinical trial of Tivdak to treat recurrent or metastatic cervical cancer.  

Tivdak significantly improved overall survival, showing a 30% reduction in the risk of death compared to treatment with chemotherapy. Results showed a statistically significant progression-free survival rate, with a 33% reduction in the risk of disease deteriorating or death compared with chemotherapy.  

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The innovaTV 301 global, randomised, open-label trial assessed Tivdak versus investigators choice of chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan or pemetrexed). The trial enrolled 502 patients.  

The additional results presented during the Presidential Symposium at the European Society of Medical Oncology (ESMO) Congress 2023 build on topline results previously announced in September of this year.  

In February 2021, Genmab and Seagen submitted a biologics licence application (BLA) for Tivdak to the FDA, seeking accelerated approval. The BLA was accepted with priority review in April 2021 and approved in September 2021. The FDA’s accelerated approval of Tivdak was based on an open-label, multi-centre, single-arm Phase II clinical trial, innovaTV 301 (NCT03438396). 

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According to GlobalData, Tivdak is forecast to make $744m in sales by 2029. GlobalData is the parent company of Clinical Trials Arena. 

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Genmab’s collaboration revenue has increased by 54% in H1 2023, driven by the increase in net sales of Tivdak, according to Genmab’s interim financial report for H1 2023.  

The innovaTV 301 clinical trial’s lead investigator Ignace Vergote said: “The positive data, seen in a representative patient population of recurrent or metastatic cervical cancer, demonstrate the potential for Tivdak to reshape clinical practice and provide hope to patients who need a new treatment option.”