Tisotumab Vedotin for Metastatic Cervical Cancer: Results From ESMO 2023 With Brian Slomovitz, MD
In this interview, Dr. Brian Slomovitz, Director of Gynecologic Oncology at Mount Sinai Medical Center in Miami Beach, Florida, shares the results of the innovaTV 301 trial of tisotumab vedotin for patients with recurrent or metastatic cervical cancer, which were recently presented at the European Society for Medical Oncology (ESMO) 2023 Congress.
Oncology Data Advisor: Welcome to Oncology Data Advisor. Today, I'm joined by Dr. Brian Slomovitz, who is live from the ESMO meeting. Dr. Slomovitz, thanks so much for coming on today.
Brian Slomovitz, MD: Thanks, Keira. Thanks for having me. My name's Brian Slomovitz. I'm a Gynecologic Oncologist in Miami Beach at Mount Sinai Medical Center. In addition, I serve within the Gynecologic Oncology Group (GOG) Partners Group, which is the group that collaborated within GOG to get this trial done.
Oncology Data Advisor: Today, we're talking about the results of the innovaTV 301 trial (abstract LBA9) that were just presented at ESMO. For background, how has tisotumab vedotin, or TV, been used for the treatment of cervical cancer?
Dr. Slomovitz: Thanks, Keira, for that question. Actually, based on the phase 2 open-label activity trial with the response rate of 24%, tisotumab vedotin—TV, we like to call it—has gotten an accelerated FDA approval and is being used in the US with that accelerated approval. This, in fact, was the confirmatory trial to get full FDA approval. It is a large, global, randomized phase 3 trial. The primary end point was overall survival. Based on these findings, we're hoping not only to have the full approval in the US but to have a global impact on this disease, which as you know, is a very deadly disease. It's one of the most common cancers seen amongst women worldwide, and we need to do better.
Oncology Data Advisor: What is the disease setting that the innovaTV 301 trial is investigating?
Dr. Slomovitz: The innovaTV 301 trial is looking at women with recurrent or metastatic cervical cancer who have failed primary therapy for systemic disease. They've failed platinum-based chemotherapy, and if available, they've also already received bevacizumab, which is an anti-angiogenic agent, as well as a checkpoint inhibitor. In patients that failed those therapies, tisotumab vedotin is being studied in the second and third line for recurrent cervical cancer.
Oncology Data Advisor: What were the safety and efficacy results of the trial that were just presented at ESMO this weekend?
Dr. Slomovitz: The most exciting result was that primary end point of overall survival was reached. In this population, we saw a 30% risk reduction of death through this disease in those women who were treated with TV. In addition, we saw a significant improvement in progression-free survival. Finally, equally as important, the safety profile was similar to what we've seen in the other TV trials. There were no new signals that we've identified.
Oncology Data Advisor: That's really exciting. Congratulations on a successful trial.
Dr. Slomovitz: Thank you.
Oncology Data Advisor: How will these results impact the use of TV and the treatment of cervical cancer?
Dr. Slomovitz: From a global perspective, based on these results of the primary end point of overall survival being reached, we should be able to incorporate this treatment into the care of most, if not all, women with this disease. Now, we do know that cervical cancer also affects women in low/middle– income countries (LMICs). Sometimes it's more difficult to get effective treatments to those areas. In general, globally, we need to do better. There's an unmet need, and these findings support the use of TV in order to help women live longer from this disease globally.
Oncology Data Advisor: Are there any additional directions or future analyses planned for the trial?
Dr. Slomovitz: This is the trial's first end point, and it is based on interim analysis, just like any large, randomized, practice-changing phase 3 trial. This is only the beginning. Even though we're happy with this end point, we need to dig deeper, looking at the different biomarkers and seeing if there are any stratification factors which could account for this benefit. Are there certain things we could use to help identify which group of women may have a more favorable response or not? So, we will look at all those subgroup analyses and those non-prespecified end points.
I just want to hammer home the fact that we got a 30% reduction in risk of death in patients treated with TV versus conventional chemotherapy. Chemotherapy doesn't work in the second- or third-line setting as well as some of these new assets, and we've demonstrated TV having an overall survival advantage. More studies will be done, but this is really exciting. One other thing that's exciting, talking about future directions, is that we are looking at the combination of TV with pembrolizumab and with carboplatin, as ways to not only get the advantages of TV but to sort of get a synergistic effect with other active agents. So, there's a lot in the future. Again, this is our first step, but we're hoping to actually have a higher impact for women who suffer from this disease.
Oncology Data Advisor: Awesome, I look forward to hearing those results as well. Thank you so much for your time today. It was wonderful to hear about these results.
Dr. Slomovitz: Thanks for having me. I really appreciate you highlighting this trial.
About Dr. Slomovitz
Brian Slomovitz, MD, is the Director of Gynecologic Oncology and Co-Chair of the Cancer Research Committee at Mount Sinai Medical Center in Miami Beach, Florida. He is also a Professor of Obstetrics and Gynecology at Florida International University and a member of the Board of Directions of the GOG Foundation. Dr. Slomovitz's research focuses on the development of novel therapeutics for gynecologic cancers, and he is the national or global principal investigator on numerous clinical trials.
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