Approval of Tisotumab Vedotin in The Treatment of Cervical Cancer - Episode 3
Considerations for the interim results of innovaTV 205, which tested tisotumab vedotin alone or in combination with other agents for patients with cervical cancer.
Rebecca Arend, MD, MPH: I also want to review the recent data from this year’s ESMO [European Society for Medical Oncology] Congress that looked at tisotumab vedotin in combination with carboplatin in first line, or in combination with pembrolizumab in previously treated second-line, third-line, recurrent or metastatic cervical cancer.
The interim results were presented at ESMO Congress, which also were extremely exciting. This showed a response rate in the TV [tisotumab vedotin] plus carboplatin cohort of 55%. In the patients who received TV [tisotumab vedotin] plus pembrolizumab, the response rate was 57% in those who received 1 prior systemic treatment. In those also who received prior bevacizumab, it was 57% with a confirmed overall response rate of 35%.
These are extremely exciting data. It’s important to note that the most common adverse effects we’re concerned about in this new antibody-drug conjugate is the ocular toxicity: in most trials it’s around 3%. Because of that, the FDA has put out a black-box warning that patients get an ophthalmologic evaluation with each cycle. Other important toxicities are some peripheral neuropathy, but the grade 3 peripheral neuropathy is usually less than 5%, and there have been some reports of bleeding.
Transcript edited for clarity.