"Available therapies upon progression after first-line chemotherapy in recurrent or metastatic cervical cancer are limited, and there is a significant unmet need for new treatment options."
Tisotumab vedotin (HuMax-TF-ADC) demonstrated clinically meaningful and durable objective responses, along with a manageable safety profile when administered to patients who relapsed or progressed on or after prior treatment for recurrent or metastatic cervical cancer, according to topline results from the phase 2 innovaTV 204 trial (NCT03438396).1
“Available therapies upon progression after first-line chemotherapy in recurrent or metastatic cervical cancer are limited, and there is a significant unmet need for new treatment options," said Roger Dansey, MD, chief medical officer at Seattle Genetics.
The agent led to an objective response rate (ORR) of 24% per independent central review (95% CI, 15.9%-33.3%). The median duration of response (DOR) observed with tisotumab vedotin was 8.3 months. Based on these positive data, Seattle Genetics is discussing submitting a Biologic License Application for accelerated approval of tisotumab vedotin to the FDA.
The single-arm, multicenter, international study is assessing the efficacy, safety, and tolerability of tisotumab vedotin with the primary end point of confirmed ORR, and DOR, progression-free survival, and overall survival as secondary end points.
Patients with extra-pelvic metastatic or recurrent cervical cancer are eligible for the innovaTV 204 trial, given they are at least 18 years of age with measurable disease per RECIST v1.1 and have an ECOG performance status of 0 or 1. Patients should also have adequate renal, liver, and hematological function. At the time of screening, patients are required to have an archival biopsy or be able to provide a new sample.
The trial excludes patients who have had more than 2 prior lines of systemic therapy for recurrent metastatic disease. Patients with bleeding disorders, active ocular surface disease, known past current malignancy other than cervical cancer, and those with peripheral neuropathy of grade 2 or higher were also excluded from the trial.1,2
Enrollment for the study was completed in March of 2019 with 102 patients. At the time, Dansey noted,2 “completing enrollment in this potentially pivotal phase 2 trial marks an important step forward in evaluating tisotumab vedotin for women with previously treated recurrent and/or metastatic cervical cancer.”
The innovaTV 204 trial is a collaborative clinical trial effort of Seattle Genetics European Network of Gynecological Oncological Trial Groups and Gynecologic Oncology Group. Tisotumab vedotin is under investigation is other clinical trials in combination with pembrolizumab (Keytruda), carboplatin, or bevacizumab (Avastin) in patients with locally advanced or metastatic cervical cancer. The agent is also being studied in other tumor types like ovarian cancer, and other solid tumors.1
Seattle Genetics announces positive topline results from phase 2 clinical trial of tisotumab vedotin in recurrent or metastatic cervical cancer. News release. Seattle Genetics, Inc. June 29, 2020. Accessed June 30, 2020. https://bit.ly/2BReG1a
Seattle Genetics completes enrollment in phase 2 clinical trial of tisotumab vedotin in recurrent or metastatic cervical cancer. News release. Seattle Genetics, Inc. March 29, 2019. Accessed June 29, 2020. https://bit.ly/2NGGO9P