Drug updated on 10/25/2024
Dosage Form | Injection (intravenous; 40 mg) |
Drug Class | Tissue factor-directed antibodies and microtubule inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
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Summary
- This summary is based on the review of one randomized controlled trial(s). [1]
- Tisotumab vedotin showed a median overall survival (OS) of 11.5 months (95% CI (Confidence interval), 9.8 to 14.9) compared to 9.5 months (95% CI, 7.9 to 10.7) with chemotherapy, with a 30% lower risk of death (HR (Hazard Ratio) 0.70; 95% CI, 0.54 to 0.89; P = 0.004).
- Progression-free survival (PFS) was significantly longer with tisotumab vedotin at 4.2 months (95% CI, 4.0 to 4.4) compared to 2.9 months (95% CI, 2.6 to 3.1) for chemotherapy (HR 0.67; 95% CI, 0.54 to 0.82; P < 0.001).
- The objective response rate (ORR) for tisotumab vedotin was 17.8%, significantly higher than the 5.2% seen with chemotherapy (OR 4.0; 95% CI, 2.1 to 7.6; P < 0.001).
- Tisotumab vedotin was associated with an overall adverse event (AE) incidence of 98.4%, with 52.0% of patients experiencing grade 3 or greater AEs, compared to chemotherapy, which had a 99.2% incidence of AEs and 62.3% for grade 3 or greater AEs.
- Treatment discontinuation due to toxic effects occurred in 14.8% of patients treated with tisotumab vedotin.
- The study population consisted of patients with recurrent or metastatic cervical cancer who were receiving second- or third-line therapy. No specific subgroup analyses were reported, and the treatment groups for tisotumab vedotin and chemotherapy were similar in terms of demographic and disease characteristics.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Tivdak (tisotumab vedotin-tftv) Prescribing Information. | 2024 | Seagen Inc., Bothell, WA |
Randomized Controlled Trials
Document Title | Sex Distribution | Year | Source |
---|---|---|---|
Tisotumab Vedotin as Second- or Third-Line Therapy for Recurrent Cervical Cancer | 502Subjects F: 100% M: 0% | 2024 | The New England Journal of Medicine |
Sex Distribution:
F:100%
M:0%
502Subjects
Year:
2024
Source:The New England Journal of Medicine