In the study, 502 patients were randomized (TV: 253; chemotherapy: 249) and the median survival follow-up was 10.8 months. Overall, median age was 50 years; arms were balanced for demographics and disease characteristics. 63.9% and 27.5% of patients had prior bevacizumab and prior anti-PD-(L)1 therapy, respectively. The TV arm had a 30% reduction in risk of death as compared to chemotherapy, with significantly longer median OS (11.5 months vs. 9.5 months). PFS was superior in the TV as compared to the chemotherapy arm. Confirmed ORR was 17.8% and 5.2% in the TV and chemotherapy arms, respectively. Most patients experienced at least one treatment-related adverse event. Adverse events (AEs) were consistent with the known TV safety profile, including for ocular, peripheral neuropathy, and bleeding AEs.

Conclusion

In the Phase III InnovaTV 301 study, TV showed a statistically significant and clinically meaningful improvement in OS, PFS, and ORR vs. chemotherapy, with a manageable and tolerable safety profile in patients with second-line/third-line R/M CC.

Tisotumab vedotin showed a statistically significant and clinically meaningful improvement in OS compared to chemotherapy. The hazard ratio for OS was 0.70, demonstrating a 30% reduction in the risk of death. Consistent benefit in PFS and confirmed ORR were also observed and supportive of the observed OS benefit with tisotumab vedotin. The safety profile of tisotumab vedotin was manageable and tolerable, and consistent with previous experience.

Based on these data, tisotumab vedotin should be considered a potential new standard of care for patients who have progressed after first-line systemic therapy.

For more insight into the patient's burden/epidemiology, treatment, and changing market landscape-related advancements of other related indications, refer to the following reports:

• Ovarian Cancer Market Insight, Epidemiology and Market Forecast
• Cervical Cancer Market Insight, Epidemiology and Market Forecast