Drug updated on 4/17/2024
| Dosage Form | Lyophilized powder (intravenous; 40 mg) |
| Drug Class | Tissue factor-directed antibodies and microtubule inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
Summary
- Tisotumab vedotin-tftv (Tivdak) is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer who have experienced disease progression on or after chemotherapy.
- Two randomized controlled trials were reviewed to gather information about this drug and its effects on the specified patient population.
- The first trial was a multicentre, open-label, single-arm, phase 2 study conducted across 35 academic centres, hospitals, and community practices in Europe and the USA involving patients aged 18 years or older with recurrent or metastatic squamous cell carcinoma of cervix; adenocarcinoma; adenosquamous cervical cancer; those who had received two or fewer previous systemic regimens for recurrent/metastatic disease.
- In this study tisotumab vedotin showed clinically meaningful antitumor activity with a manageable safety profile in women previously treated for recurrent/metastatic cervical cancer - confirmed objective response rate was found to be 24% (95% CI:16-33), including seven complete responses and seventeen partial responses.
- Common treatment-related adverse events included alopecia (38%), epistaxis (30%), nausea (27%), conjunctivitis (26%), fatigue (26%), and dry eye (23%). Grade 3 or worse treatment-related adverse events occurred in approximately one-fourth of the participants and included neutropenia, fatigue, ulcerative keratitis, and various peripheral neuropathies, among others.
- One death due to septic shock was considered by investigators as related to therapy while three deaths unrelated to treatment were reported during the course of this trial.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Tivdak (tisotumab vedotin-tftv) Prescribing Information. | 2023 | Seagen Inc., Bothell, WA |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Efficacy and safety of tisotumab vedotin in previously treated recurrent or metastatic cervical cancer (innovaTV 204/GOG-3023/ENGOT-cx6): a multicentre, open-label, single-arm, phase 2 study. | 101Subjects F: 100% M: 0% | 2021 | The Lancet Oncology |
| Tisotumab vedotin in previously treated recurrent or metastatic cervical cancer. | 55Subjects F: 100% M: 0% | 2020 | Clinical Cancer Research |
Sex Distribution:
F:100%
M:0%
101Subjects
Year:
2021
Source:The Lancet Oncology
Sex Distribution:
F:100%
M:0%
55Subjects
Year:
2020
Source:Clinical Cancer Research