innovaTV 301
Trial question
What is the role of tisotumab vedotin in patients with recurrent cervical cancer?
Study design
Multi-center
Open label
RCT
Population
502 female patients
Inclusion criteria: patients with recurrent or metastatic cervical cancer
Key exclusion criteria: cancer with primary neuroendocrine, lymphoid, sarcomatoid, or other histologic features; clinically significant bleeding or cardiovascular issues or risks
Interventions
N=253 tisotumab vedotin (2.0 mg/kg every 3 weeks)
N=249 chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed)
Primary outcome
Median overall survival
11.5
9.5
11.5 months
8.6 months
5.8 months
2.9 months
0.0 months
Tisotumab
vedotin
Chemotherapy
Significant
increase ▲
Significant increase in median overall survival (11.5 months vs. 9.5 months; HR 1.43, 95% CI 1.12 to 1.85)
Secondary outcomes
Significant increase in median progression-free survival (4.2 months vs. 2.9 months; HR 1.49, 95% CI 1.22 to 1.85)
Significant increase in confirmed objective response rate (17.8% vs. 5.2%; OR 4, 95% CI 2.1 to 7.6)
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients with recurrent or metastatic cervical cancer, tisotumab vedotin was superior to chemotherapy with respect to median overall survival.
Reference
Ignace Vergote, Antonio González-Martín, Keiichi Fujiwara et al. Tisotumab Vedotin as Second- or Third-Line Therapy for Recurrent Cervical Cancer. N Engl J Med. 2024 Jul 4;391(1):44-55.
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