Novel Therapy May Address ‘High Unmet Clinical Need’ in Recurrent/Metastatic Cervical Cancer

Women with previously treated recurrent or metastatic cervical cancer treated with the novel antibody-drug conjugate tisotumab vedotin had a durable antitumor activity with a manageable safety profile, according to a study published in Lancet Oncology.

“Women with recurrent or metastatic cervical cancer have a high unmet clinical need because this disease is incurable and lacks a standard of care after progression on first-line treatment,” the study authors wrote. “The multiple mechanisms of action of tisotumab vedotin, including (monomethyl auristatin E)-directed cytotoxicity, bystander effect and immunogenic effects, might contribute to the promising efficacy observed in our study.”

To assess the activity and safety of tisotumab vedotin in this specific patient population, researchers analyzed data from 101 women (median age, 50 years) with previously treated recurrent or metastatic cervical cancer. All patients were treated with 2 mg/kg (a maximum of 200 mg) of tisotumab vedotin intravenously once every three weeks until unacceptable toxicity or disease progression. Researchers were interested in the confirmed objective response rate, defined as the percentage of patients with partial and complete responses to the treatment.

Follow-up was conducted for a median of 10 months. During the study, the median treatment duration was 4.2 months, with a median number of doses received of six.

The confirmed objective response rate for all patients was 24%, which included 17% with partial responses and 7% with complete responses.

Some of the most common side effects related to treatment with tisotumab vedotin included nosebleed (30%), patchy hair loss (38%), fatigue (26%), pink eye (26%) and dry eye (23%). Severe or worse side effects related to the treatment occurred in 28% of patients and included fatigue (2%), inflammation and ulcers of the cornea (2%), low neutrophil bloods counts (3%) and numbness, pain and weakness in the hands and feet from nerve damage (2%). Serious side effects from the treatment were reported by 13% of patients and included fever (2%) and numbness or weakness in the fingers and feet (2%).

Researchers considered one death from septic shock related to treatment with tisotumab vedotin. There were also three deaths unrelated to the treatment: one from an obstruction in a part of the bowel preventing it from moving waste from the body and two from unknown causes.

“Taken together with a disease control rate of 72%, these data emphasize clinical improvement in a patient population in which rapid response and reduction in tumor burden are crucial for controlling rapidly progressing disease,” the study authors wrote.

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