Dr Vergote on the Efficacy of Tisotumab Vedotin in Recurrent/Metastatic Cervical Cancer

Ignace B. Vergote, MD, PhD, chairman, Leuven Cancer Institute, head, Department of Obstetrics and Gynecology and Gynecologic Oncology, the Catholic University of Leuven, Belgium, discusses the efficacy of tisotumab vedotin-tftv (Tivdak) in patients with recurrent or metastatic cervical cancer, according to data from the phase 3 innovaTV 301/ENGOT-cx12/GOG-3057 trial (NCT04697628).

The single-arm trial enrolled patients with recurrent or metastatic cervical cancer and documented disease progression on or after doublet chemotherapy with or without bevacizumab and an anti–PD(L)1 agent, if eligible and available. Patients were randomly assigned 1:1 to receive either intravenous tisotumab vedotin (n = 253) or investigator’s choice of either topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed (n = 249).

Previously reported data from this trial supported the FDA's accelerated approval of tisotumab vedotin in 2021 for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, Vergote notes.

Results from a planned interim analysis of the trial were presented at the 2023 ESMO Congress, and showed that patients treated with tisotumab vedotin experienced a 30% reduction in the risk of death vs investigator’s choice of chemotherapy as second- or third-line therapy. At a median follow-up of 10.8 months (95% CI, 10.3-11.6), tisotumab vedotin produced a statistically significant and clinically meaningful improvement in median OS of 11.5 months (95% CI, 9.8-14.9) vs 9.5 months (95% CI, 7.9-10.7) with chemotherapy (HR, 0.70, 95% CI, 0.54-0.89; P = .0038). The 12-month OS rates were 48.7% with tisotumab vedotin and 35.3% with chemotherapy.

Additionally, tisotumab vedotin produced a median progression-free survival (PFS) of 4.2 months (95% CI, 4.0-4.4) compared with 2.9 months (95% CI, 2.6-3.1) with chemotherapy (HR, 0.67; 95% CI, 0.54-0.82; P < .0001). The 6-month PFS rates were 30.4% and 18.9% with tisotumab vedotin and chemotherapy, respectively.

These updated data further support the use of tisotumab vedotin as a standard of care for patients in this population who have historically had limited treatment options, Vergote concludes.