Tisotumab Vedotin Survival Data in Cervical Cancer Are “Game-Changing”

Tisotumab vedotin-tftv (Tivdak) has produced “tremendous” clinical activity with respect to overall survival (OS) and progression-free survival (PFS) among patients with second- or third-line recurrent or metastatic cervical cancer, according to Brian Slomovitz, MD, MS, FACOG.

In an interview with CancerNetwork^®, Slomovitz, director of Gynecologic Oncology at Mount Sinai Medical Center in Miami Beach, Florida and a Uterine Cancer Clinical Trial lead within the Gynecologic Oncology Group (GOG) Foundation, spoke about key efficacy findings from the phase 3 innovaTV 301/ENGOT-cx12/GOG-3057 trial (NCT04697628) and how they support tisotumab vedotin as a potential standard of care in the aforementioned patient population. He presented these data at the 2023 Annual Global Meeting of the International Gynecologic Cancer Society (IGCS).

Data from the trial highlighted a median OS of 11.5 months (95% CI, 9.8-14.9) with tisotumab vedotin compared with 9.5 months (95% CI, 7.9-10.7) in patients treated with chemotherapy (HR, 0.70; 95% CI, 0.54-0.89; P = .0038). Additionally, the median PFS was 4.2 months (95% CI, 4.0-4.4) vs 2.9 months (95% CI, 2.6-3.1) in each respective arm (HR, 0.67; 95% CI, 0.54-0.82; P <.0001).

Transcript:

We believe that the results are actually game changing. What we found is a statistically significant improvement in overall survival. In those patients treated on the experimental arm vs the standard of care, there's a 30% decreased risk of death in those patients treated with tisotumab vedotin when compared with investigator choice chemotherapy. In addition, there was a 33% decrease in progression or death due to disease as far as the progression-free survival, demonstrating the tremendous activity of this drug in this setting.

Tisotumab vedotin needs to be incorporated into the second- or third-line management of this disease. As we move checkpoints into the first line, there's a great opportunity here for a second-line agent, as we don't have anything better at this time. Response rates were 17% [with tisotumab vedotin] vs 5% with chemotherapy; another difference that we didn't highlight yet. It's game changing. It's worthy of incorporating into the standard of care for those patients in the second-line setting who [progressed on] first-line platinum-based therapy.

Reference

Slomovitz BM, Martin AG, Fujiwara K, et al. innovaTV 301/ENGOT-cx12/GOG-3057: a global, randomized, open-label, phase 3 study of tisotumab vedotin vs investigator's choice of chemotherapy in 2L or 3L recurrent or metastatic cervical cancer. Presented at 2023 Annual Global Meeting of the International Gynecologic Cancer Society; November 5-7, 2023; Seoul, South Korea; abstract SE006/1616