The Food and Drug Administration has granted accelerated approval to Tivdak™ (tisotumab vedotin-tftv) for the treatment of adults with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
Tivdak is a tissue factor-directed antibody and microtubule inhibitor conjugate. The approval was based on data from the open-label, multicenter, single-arm phase 2 innovaTV 204 trial (ClinicalTrials.gov: NCT03438396), which evaluated tisotumab vedotin-tftv as monotherapy in 101 adult females with recurrent or metastatic cervical cancer who were treated with no more than 2 prior systemic regimens in the recurrent or metastatic setting, including at least 1 prior platinum-based chemotherapy regimen.
Patients received tisotumab vedotin-tftv 2mg/kg intravenously once every 3 weeks until disease progression or unacceptable toxicity. The primary efficacy outcomes were objective response rate, as assessed by an independent review committee using RECIST v1.1 criteria and duration of response.
Results showed a confirmed objective response rate of 24% (95% CI, 15.9-33.3), with 7% of patients achieving complete response and 17% having partial response. The median duration of response was 8.3 months (95% CI, 4.2-not reached).
As for safety, Tivdak carries a Boxed Warning regarding ocular toxicity. Changes in vision, including severe vision loss, and corneal ulceration have been reported. Peripheral neuropathy, hemorrhage, and pneumonitis also occurred across clinical trials.
The most common adverse reactions were decreased hemoglobin, fatigue, decreased lymphocytes, nausea, peripheral neuropathy, alopecia, epistaxis, conjunctival adverse reactions, hemorrhage, decreased leukocytes, increased creatinine, dry eye, increased prothrombin international normalized ratio, activated partial thromboplastin time prolonged, diarrhea, and rash.
Tivdak is supplied as a lyophilized cake or powder for reconstitution in a single-dose vial containing 40mg of tisotumab vedotin-tftv.
- Seagen and Genmab announce FDA accelerated approval for Tivdak™ (tisotumab vedotin-tftv) in previously treated recurrent or metastatic cervical cancer. News release. Seagen Inc. and Genmab US, Inc. Accessed September 21, 2021. https://www.businesswire.com/news/home/20210920005921/en/Seagen-and-Genmab-Announce-FDA-Accelerated-Approval-for-TIVDAK%E2%84%A2-tisotumab-vedotin-tftv-in-Previously-Treated-Recurrent-or-Metastatic-Cervical-Cancer.
- Tivdak. Package insert. Seagen Inc. and Genmab US, Inc.; 2021. Accessed September 21, 2021. https://seagendocs.com/Tivdak_Full_Ltr_Master.pdf.