Efficacy of Tisotumab vedotin-tftv

Tisotumab vedotin-tftv is an antibody-drug conjugate indicated for the treatment of adult patients with recurrent or metastatic cervical cancer (R/MCC) whose disease has progressed during or after chemotherapy in the pivotal Phase II innovaTV Durable responses with clinically meaningful and manageable safety were demonstrated in 204 clinical trials. Based on the proposed mechanism of action, clinical trial experience, and U.S. prescribing information for Vitin-Tisotuzumab, certain adverse events (AEs) including ocular adverse events, peripheral neuropathy, and bleeding have been determined to be relevant adverse events.

In the pivotal Phase II innovaTV 204 study, Vitin-Tisotuzumab was evaluated in patients with R/MCC who had previously received dual chemotherapy plus bevacizumab. A total of 101 patients received vitin-tisotuzumab 2 mg/kg (up to 200 mg) as a 30-minute intravenous infusion every 3 weeks until disease progression or unacceptable toxicity. Vitin-Tisotuzumab demonstrated clinically meaningful and durable antitumor activity, with an objective response rate (as assessed by an independent review committee) of 24% and median duration of response of 8.3 months; antitumor activity was observed regardless of histology, prior therapy, or tissue factor expression. The median duration of response was 1.4 months, indicating a rapid antitumor response with potential antitumor activity within the first two treatment cycles. The median progression-free survival (PFS) , 6-month PFS rate and median overall survival were 4.2 months, 30% and 12.1 months respectively.

Most adverse events were mild to moderate in severity,92% of patients experienced treatment-related adverse events and 28% experienced at least one grade grade 3 or higher treatment-related adverse event. Thirteen percent had serious treatment-related adverse events, one of which was fatal. Prespecified related adverse events included ocular adverse events, peripheral neuropathy, and bleeding. In the prescription information of Vitin-tisotuzumab, we also learned about the warnings and precautions such as ocular adverse reactions, peripheral neuropathy, bleeding, pneumonia, severe skin adverse reactions, embryo-fetal toxicity, etc.

Vitin-TisotumabThe original drug has not yet been marketed in China, so it cannot be included in medical insurance. The original drugs marketed overseas are very expensive. The price of each box of 40mg/vial may be around RMB 90,000 (the price may fluctuate due to the exchange rate). Currently, there is no Vitin-The generic version of tisotumab is produced and launched. For more drug information and specific prices, please consult the medical consultant.