In a phase II study (innovaTV 204/GOG-3023/ENGOT-cx6) reported in The Lancet Oncology, Robert L. Coleman, MD, and colleagues found that the antibody-drug conjugate tisotumab vedotin produced durable responses in previously treated patients with recurrent or metastatic cervical cancer.
Robert L. Coleman, MD
In the trial, 101 patients with measurable disease from sites in Europe and the United States were enrolled between June 2018 and April 2019. Patients had recurrent or metastatic squamous cell, adenocarcinoma, or adenosquamous cervical cancer; disease progression on or after doublet chemotherapy with bevacizumab; and had received two or fewer previous systemic regimens for recurrent or metastatic disease. Treatment consisted of tisotumab vedotin given intravenously at 2.0 mg/kg (up to a maximum of 200 mg) once every 3 weeks until disease progression or unacceptable toxicity. The primary endpoint was confirmed objective response rate on Response Evaluation Criteria in Solid Tumors version 1.1.
Median follow-up at the time of analysis was 10.0 months (interquartile range = 6.1–13.0 months). Objective response was observed in 24 patients (24%, 95% confidence interval [CI] = 16%–33%), including complete response in 7 (7%). An additional 49 patients (49%) had stable disease, yielding a disease control rate of 72%. Median duration of response was 8.3 months (95% CI = 4.2 months–not reached). Median progression-free survival was 4.2 months, with a 6-month rate of 30%. Median overall survival was 12.1 months, with 6- and 12-month rates of 79% and 51%.
The most common treatment-related adverse events of any grade included alopecia (38%), epistaxis (30%), nausea (27%), conjunctivitis (26%), fatigue (26%), and dry eye (23%).
The investigators concluded, “Tisotumab vedotin showed clinically meaningful and durable antitumor activity with a manageable and tolerable safety profile in women with previously treated recurrent or metastatic cervical cancer.”