Ignace Vergote, MD, PhD, University of Leuven, Belgium, discusses results from the phase 3 innovaTV 301/ENGOT-cx12/GOG-3057 trial comparing tisotumab vedotin, a human monoclonal antibody-drug conjugate, against standard-of-care chemotherapy among patients with recurrent or metastatic cervical cancer.

Results demonstrated that tisotumab vedotin significantly improved progression-free survival, overall survival, and the objective response rate compared to standard-of-care chemotherapy with a manageable and tolerable safety profile.

Dr Vergote presented these results at the 2023 ESMO Congress in Madrid, Spain.

Transcript:

Hi, my name is Ignace Vergote, I'm a Professor at the University of Leuven, [Belgium] and a gynecological oncologist. I was happy to present in the Presidential Session, the results of the phase 3 trial innovaTV 301—we also call it ENGOT-cx12 here in Europe.

This study was done in a population with a very poor prognosis: patients with cervical cancer who have had first-line treatment with usually chemotherapy and now also usually [immunotherapy] IO therapy, and then after that once they progress on this treatment, we have no real standard of care anymore. We use some chemotherapies with low response rates, 5% or something like that, [progression-free survival] PFS less than 3 months.

In this population we tested the new antibody drug conjugate, tisotamab vedotin, which we also call TV, and it's an antibody human monoclonal antibody directed against tissue factor which is almost always present in cervical cancer. It's linked to vedotin or monomethylolestatin E, which is a microtubule disrupting agent, and vedotin has been linked to other antibodies and shown in the same Presidential Session for instance to be very effective in bladder cancer. It's a similar mode of action but a different antibody in this case against tissue factor.

We randomized 502 patients [to] tisotamab vedotin given [intravenously] IV every 3 weeks versus standard chemotherapy, they could choose 1 of 5 drugs, like I said all very similar efficacy but very low efficacy. The primary end point of the study was overall survival, but we also tested for PFS, objective response rate, toxicity, and quality of life, of course and it was very good to see that the primary end point we hit the threshold by far. It was a highly significant study with a hazard ratio of 0.70, so 30% reduction in death rate and a 33% reduction in progression free survival.

This drug is an antibody drug conjugate, so it has some side effects, but it results in better quality of life, or certainly not worse quality of life, compared to the classical chemotherapy. Classical chemotherapy has more nausea, anemia, bone marrow toxicity while this drug has typical side effects as well, but which are usually recovered quite quickly and almost always grade 1 or 2.

I believe that we have a new standard of care in second- or third-line recurrent metastatic cervical cancer, and I was very happy to be able to present this data at the ESMO meeting.

Source:

Vergote IB, Gonzalez Martin A, Fujiwara K, et al. innovaTV 301/ENGOT-cx12/GOG-3057: A global, randomized, open-label, phase III study of tisotumab vedotin vs investigator’s choice of chemotherapy in 2L or 3L recurrent or metastatic cervical cancer. Presented at 2023 ESMO Annual Congress; October 20-24, 2023; Madrid, Spain. Abstract LBA9.