Multinational phase 3 trial of tisotumab vedotin as second- or third-line therapy for recurrent cervical cancer

Patients with recurrent cervical cancer have a poor prognosis and limited treatment options. The multinational phase 3 innovaTV 301 evaluated the tissue factor-targeted antibody-drug conjugate tisotumab vedotin (TV) as second- or third-line therapy for recurrent or metastatic cervical cancer. Patients were randomized to TV or investigator’s choice of chemotherapy. Median overall survival (primary end point) was 11.5 months with TV versus 9.5 months with chemotherapy (HR 0.70; p=0.004). Median progression-free survival was 4.2 months with TV versus 2.9 months with chemotherapy (HR 0.67; p<0.001). Confirmed objective response rate was 17.8% in the TV group and 5.2% in the chemotherapy group (OR 4.0; p<0.001). Grade 3 or greater adverse events occurred in 52.0% of patients in the TV group and 62.3% of patients in the chemotherapy group. Discontinuation of TV because of toxic effects was reported for 14.8% of patients. The authors conclude that in patients with recurrent or metastatic cervical cancer, second- or third-line TV had significantly greater efficacy than chemotherapy.