Genmab and Seattle Genetics have collaborated to evaluate tisotumab vedotin in a Phase II clinical trial for the treatment of patients suffering from recurrent and/or metastatic cervical cancer.
Tisotumab vedotin comprises Genmab's human antibody antibody that targets tissue factor (TF) along with Seattle Genetics' antibody-drug conjugate (ADC) technology that includes a cleavable linker and cytotoxic drug, monomethyl auristatin E (MMAE).
The single arm, multi-centre Phase II trial is designed to enrol approximately 100 patients who relapsed or progressed following standard of care treatment with platinum containing chemotherapy and bevacizumab.
Planned to be initiated over the coming months, the results from the trial are expected to support a regulatory application for the approval of tisotumab vedotin.
Seattle Genetics president and CEO Clay Siegall said: "Standard therapies for previously treated recurrent and/or metastatic cervical cancer generally result in response rates of less than 15% and a median overall survival of six to eight months.
"Based on promising data from the Phase I/II clinical trial of tisotumab vedotin in recurrent and/or metastatic cervical cancer and feedback from the US Food and Drug Administration (FDA) on the planned trial, we and Genmab are advancing the programme into a potentially registrational study for these patients with high unmet medical need."
The trial’s primary endpoint is overall response rate (ORR) as measured through independent review of RECIST v1.1 criteria, while the main secondary endpoints include duration of response (DoR) and safety.
Tisotumab vedotin is being further investigated in Phase I/II trials to treat solid tumours.
Image: Cervical adenocarcinoma. Photo: courtesy of Ed Uthman/Flickr.