Tisotumab vedotin for recurrent cervical cancer

A new phase 3 study recently published on The New England Journal of Medicine has shown a greater efficacy for tisotumab vedotin, a tissue factor-specific antibody linked to monomethyl auristatin E, over chemotherapy when used as a second or third line treatment in recurrent cervical cancer.

Tisotumab vedotin showed encouraging and durable response in patients with recurrent or metastatic cervical cancer in a prior phase 2 trial, leading to an accelerated approval in the US; authors thus conducted a phase 3, multinational, open-label trial of tisotumab vedotin as second- or third-line therapy in these patients. A total of 502 patients with recurrent or metastatic cancer and a previous systemic therapy underwent randomization: 253 were assigned to the tisotumab vedotin group and 249 to the investigator’s choice of chemotherapy group (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed). The median overall survival, primary endpoint of the study, was significantly longer in the tisotumab vedotin group than in the chemotherapy group (11.5 months vs. 9.5 months), with a 30% lower risk of death with tisotumab vedotin than with chemotherapy; the median progression-free survival was 4.2 months with tisotumab vedotin and 2.9 months with chemotherapy, the objective response rate was 17.8%  and 5.2% respectively. The incidence of adverse events was similar in both groups; a total of 14.8% of patients stopped tisotumab vedotin treatment because of toxic effects. «The innovaTV 301 trial showed that tisotumab vedotin resulted in significantly greater efficacy, including longer overall survival, than chemotherapy in patients with recurrent cervical cancer. These data suggest that tisotumab vedotin may be a preferred second-line or third-line treatment option over chemotherapy for patients with recurrent cervical cancer», the authors conclude.