The New England Journal of MedicineTisotumab Vedotin as Second- or Third-Line Therapy for Recurrent Cervical Cancer

Tisotumab Vedotin Demonstrates Improved Survival in Recurrent Cervical Cancer, Offering New Treatment Option

A phase 3 clinical trial has shown that tisotumab vedotin, used as second- or third-line therapy, significantly improves overall survival in patients with recurrent or metastatic cervical cancer compared to standard chemotherapy. This multinational, open-label study provides evidence for a potentially effective treatment option in a patient population with limited alternatives after disease progression following first-line combination therapy.

Study Design:

• Phase 3, multinational, open-label trial
• 502 patients with recurrent or metastatic cervical cancer
• Randomization: 1:1 ratio (253 tisotumab vedotin, 249 chemotherapy)
• Tisotumab vedotin dosage: 2.0 mg per kilogram of body weight every 3 weeks
• Chemotherapy options: Topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed
• Primary endpoint: Overall survival

Key Findings:

• Median overall survival:
  • Tisotumab vedotin: 11.5 months (95% CI, 9.8 to 14.9)
  • Chemotherapy: 9.5 months (95% CI, 7.9 to 10.7)
  • 30% lower risk of death with tisotumab vedotin (HR 0.70; 95% CI, 0.54 to 0.89; P=0.004)
• Median progression-free survival:
  • Tisotumab vedotin: 4.2 months (95% CI, 4.0 to 4.4)
  • Chemotherapy: 2.9 months (95% CI, 2.6 to 3.1)
  • HR 0.67; 95% CI, 0.54 to 0.82; P<0.001
• Confirmed objective response rate:
  • Tisotumab vedotin: 17.8%
  • Chemotherapy: 5.2%
  • Odds ratio: 4.0; 95% CI, 2.1 to 7.6; P<0.001
• Adverse events during treatment period:
  • Tisotumab vedotin: 98.4% of patients
  • Chemotherapy: 99.2% of patients
• Grade 3 or greater adverse events:
  • Tisotumab vedotin: 52.0% of patients
  • Chemotherapy: 62.3% of patients
• Treatment discontinuation due to toxicity:
  • Tisotumab vedotin: 14.8% of patients

HCN Medical Memo
The significant improvement in overall survival and progression-free survival with tisotumab vedotin, coupled with its manageable safety profile, positions this therapy as a potential new standard for second- or third-line treatment of recurrent cervical cancer. Physicians should consider this option for eligible patients who have progressed after first-line combination therapy, given its demonstrated efficacy over current chemotherapy regimens.

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