Approval of Tisotumab Vedotin in The Treatment of Cervical Cancer - Episode 3

Interim Results of the InnovaTV 205 Trial in Cervical Cancer

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.