Approval of Tisotumab Vedotin in The Treatment of Cervical Cancer - Episode 2

InnovaTV 204 Trial in Cervical Cancer: Study Design and Key Efficacy Results

Rebecca Arend, MD, MPH, reviews the study design and results from innovaTV 204, which tested tisotumab vedotin in previously treated, recurrent, or metastatic cervical cancer.


Rebecca Arend, MD, MPH: I want to discuss the innovaTV 204 trial, or GOG-3023, ENGOT-cx6, which was a pivotal phase 2, open-label, single-arm multicenter trial in the United States and Europe that looked at tisotumab vedotin, 2 mg/kg IV [intravenous] that was given every 3 weeks. The total number of patients was 101, and the key eligibility criteria for this trial was anybody with recurrent or extra pelvic metastatic cervical cancer that had progressed during doublet chemotherapy or after doublet chemotherapy.

Bevacizumab was optional in terms of whether you had received it before. If you were eligible, you should have previously received bevacizumab based on the GOG-240 regimen; the design of this trial was for second line after progressing on doublet therapy. You had to have received less than or equal to 2 prior systemic regimens and have a performance status of 0 to 1. The drug was given until progressive disease or unacceptable toxicity.

Responses were done at baseline every 6 weeks, and the primary end point was overall response rate. Secondary end point included overall response rate for RECIST by the investigator, disease control rate, progression-free survival, overall survival, and safety. The most exciting thing is that this has now led to an FDA approval in addition to a recent publication in The Lancet Oncology by [Robert] Coleman, et al.

I want to discuss the major exciting end points for GOG-3023, which is the overall response rate of 24%. This is in all comers despite what the H-score [histology score] of your tissue factor was or how high your expression of tissue factor was. If we put this into historical perspective, we haven’t seen anything with a response and second-line or greater. In cervical cancer, we don’t have many options for these patients. One of the exciting things that has come out recently for these patients are, in those patients who are PD-L1 positive, greater than 1% who are eligible for pembrolizumab. If you think about those data, even in those patients the overall response rate is only about 14%. An overall response rate of 24% in recurrent cervical cancer patients who are second-line or greater is extremely exciting.

Seven of those patients had a complete response; 62% of patients are ongoing with a response rate of greater than 6 months. All of that is extremely exciting, which has led to FDA approval. This gives us another option for patients with recurrent cervical cancer that we haven’t had before.

Transcript edited for clarity.