Dr. Hong on the Safety Profile of Tisotumab Vedotin in Cervical Cancer

David S. Hong, MD, deputy director of the Department of investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, discusses the safety profile of tisotumab vedotin (HuMax-TF-ADC) in patients with cervical cancer.

In the phase II InnovaTV 201 study, patients with previously treated recurrent or metastatic cervical cancer received the antibody—drug conjugate tisotumab vedotin. The agent showed high levels of clinical activity with a suitable safety profile. The most common adverse event (AE) observed in patients was nose bleeding, most of which were grade 1. Fatigue was the second most common AE. Investigators anticipated 3 types of AEs as a result of the mechanism of action of tisotumab vedotin, says Hong; these included neurotoxicity, bleeding events, and ocular toxicity.

In addition to the patients who experienced nose bleeds, a subset of patients experienced vaginal bleeding. However, Hong says further analysis led researchers to believe that those events were more likely a result of the underlying disease rather than the medication. In the phase I study, several incidences of ocular toxicity were reported, including conjunctivitis and dry eyes. In the phase II trial, investigators intervened with steroid eye drops, cooling masks during infusion, and dose reductions, which reduced the incidence of ocular toxicity. Overall, this is a safe and effective drug, concludes Hong.