A single arm, phase 2, multicenter, international trial of tisotumab vedotin (HuMax-TF-ADC) in previously treated, recurrent or metastatic cervical cancer.

TPS5601Background: Cervical cancer treatment options are limited for patients with recurrent and/or metastatic cervical cancer. Tisotumab vedotin (TV) is an antibody-drug conjugate (ADC) composed of a human antibody targeted to tissue factor (TF), a protease-cleavable linker and the potent microtubule-disrupting agent monomethyl auristatin E (MMAE). The phase 1/2 GEN701 trial (NCT02001623) initially enrolled 34 patients with recurrent or metastatic cervical cancer in the cervical expansion cohort. Treatment with intravenous TV at 2 mg/kg every 3 weeks resulted in an overall response rate of 32% (confirmed and unconfirmed responses) by investigator review per RECIST v1.1 as a part of preliminary analysis. Furthermore, TV was safe and tolerable with a safety profile generally consistent with other MMAE-based ADCs Methods: This is an international, multicenter, open-label, non-randomized phase 2 trial evaluating efficacy of TV in approximately 100 patients with recurrent and/or metastatic cervical cancer who...