Summary

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• Tivdak (tisotumab vedotin-tftv) is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
• This summary is based on the review of three randomized controlled trial(s). ^[1-3]
• Objective Response Rate (ORR): The ORR for first-line (1L) TV + Carboplatin was 54.5% (95% CI: 36.4 to 71.9), for first-line (1L) TV + Pembrolizumab was 40.6% (95% CI: 23.7 to 59.4), and for second-/third-line (2L/3L) TV + Pembrolizumab was 35.3% (95% CI: 19.7 to 53.5). In previously treated patients, single-agent TV showed an ORR of 24% (95% CI: 16-33%).
• Duration of Response (DOR): The median DOR was 8.6 months for 1L TV + Carboplatin, not reached for 1L TV + Pembrolizumab, and 14.1 months for 2L/3L TV + Pembrolizumab. For single-agent TV, DOR ranged from 4.2 months (investigator-assessed) to 6.0 months (independent review).
• Progression-Free Survival (PFS): The 6-month PFS rate for single-agent TV was 29% (95% CI: 17%-43%) by investigator assessment and 40% (95% CI: 24%-55%) by independent review.
• Common Grade ≥3 adverse events include anemia, diarrhea, nausea, and thrombocytopenia (specific to arm D); anemia (specific to arm F); no Grade ≥3 AEs were ≥15% in arm E.
• Treatment-related adverse events include alopecia (38%), epistaxis (30%), and nausea (27%); Grade ≥3 treatment-related AEs include neutropenia (3%) and ulcerative keratitis (2%); serious treatment-related AEs include peripheral sensorimotor neuropathy (2%); one death due to septic shock related to therapy.
• Common Grade 3/4 treatment-emergent AEs include anemia (11%), fatigue (9%), and vomiting (7%); no Grade 5 treatment-related AEs occurred.
• The reviewed studies provide information on populations with recurrent or metastatic cervical cancer, with subgroups including treatment-naive and previously treated patients, patients aged 18 years or older with various histological types of cervical cancer and disease progression after doublet chemotherapy with bevacizumab, and patients with a history of multiple treatments including bevacizumab and doublet chemotherapy, with a significant portion having squamous cell carcinoma.