Susan C. Modesitt, MD, discusses the introduction of antibody drug conjugate tisotumab vedotin to treatment for patients with metastatic cervical cancer.
Susan C. Modesitt, MD, professor in the department of gynecology and obstetrics and director of the division of gynecologic oncology at the Emory University School of Medicine and Winship Cancer Institute, discusses the introduction of tisotumab vedotin-tftv (Tivdak) to the treatment armamentarium for patients with metastatic cervical cancer.
Tisotumab marked the first antibody-drug conjugate (ADC) to be approved for these patients, after the FDA approved the drug in 2021. The accelerated approval was based on the phase 2 innovaTV 204 clinical trial (NCT03438396), which looked at efficacy of the treatment in 101 evaluable patients. The trial showed an objective response rate (ORR) of 24.0% (95% CI, 15.9%-33.3%) among patients treated with at least 2 prior systemic therapies, with 94% having extrapelvic metastatic disease and 68% had a squamous cell carcinoma histology.
Seven percent of patients had a complete response, 17% had a partial response, 49% had stable disease, and 24% had progressive disease. Moreover, most of the patients responded quickly to treatment with tisotumab vedotin, and there was a median time to response of 1.4 months (range, 1.1-5.1). These responses lasted for a median of 8.3 months (range, 4.2–not reached).
Modesitt explains how these data have changed physicians’ treatment considerations and how far the field has come with ADCs proving viable in this patient population.
0:08 | The latest thing is, even after the immunotherapy and anti-angiogenic [treatments], is we now have kind of the new kid on the block, which are the ADCs. And there are a lot of exciting things coming out in this space, the first thing that came to market right now and the first thing that came out is tisotumab vedotin. This drug, again, shows an impressive response and what it is, is that it is targeted to tissue factor. So, it has an antibody-targeting tissue factor, then a linker, and then it has the active drug that disrupts microtubules. And so, this has an ORR of about 24%, and again, sustained responses for these women and it's just stuff that we haven't seen before.
0:51 | So all of a sudden, whereas before, often we were talking to women with recurrent cervical cancer who didn't have surgery or radiation options as essentially maybe working towards best supportive care, or not even bothering to do the chemotherapy because it wasn't very helpful, to now where we have targeted therapies. We have anti-angiogenic, we have immunotherapies, and there's even more coming down the line with some of the exciting new data coming out with other ADCs.