Tisotumab Vedotin Effective for Recurrent Cervical Cancer

MONDAY, July 8, 2024 -- A new study indicates that tisotumab vedotin shows promise as a second- or third-line treatment for patients with recurrent cervical cancer. Published in the July 4 issue of the New England Journal of Medicine, the research points to its efficacy in extending survival and slowing disease progression in these patients.

Led by Ignace Vergote, M.D., Ph.D., from Universitaire Ziekenhuizen Leuven in Belgium, the study was a phase 3, multinational, open-label trial involving 502 participants with recurrent or metastatic cervical cancer. The patients were randomly assigned to receive either tisotumab vedotin (2.0 mg per kilogram of body weight every three weeks) or the investigator's choice of chemotherapy, with 253 patients in the tisotumab vedotin group and 249 in the chemotherapy group.

The results of the study were noteworthy. The median overall survival was 11.5 months for the tisotumab vedotin group compared to 9.5 months for the chemotherapy group. This translated to a hazard ratio of 0.70, implying a lower risk of death for those treated with tisotumab vedotin. Additionally, median progression-free survival was longer for the tisotumab vedotin group at 4.2 months compared to 2.9 months for those receiving chemotherapy, yielding a hazard ratio of 0.67.

The confirmed objective response rate—an important measure of how well the treatment worked—was also higher for tisotumab vedotin at 17.8 percent, versus 5.2 percent for chemotherapy, with an odds ratio of 4.0. This indicates that patients were much more likely to experience a reduction in tumor size with tisotumab vedotin.

Adverse events were common in both treatment groups, with at least one adverse event occurring in 98.4 percent of the tisotumab vedotin group and 99.2 percent of the chemotherapy group. However, severe adverse events (grade 3 or greater) were less frequent in the tisotumab vedotin group at 52.0 percent, compared to 62.3 percent in the chemotherapy group. Notably, 14.8 percent of patients discontinued tisotumab vedotin due to toxic effects.

The authors of the study suggest that these findings support the use of tisotumab vedotin as a preferred option for second-line or third-line treatment in patients with recurrent cervical cancer. The research was funded by Genmab and Seagen, the latter of which was acquired by Pfizer in December 2023. The development of tisotumab vedotin was a collaborative effort between Genmab and Pfizer.