Approval of Tisotumab Vedotin in The Treatment of Cervical Cancer - Episode 5
Rounding out her discussion on the use of tisotumab vedotin in cervical cancer, Rebecca Arend, MD, MPH, considers other agents being investigated and how that may impact the future treatment landscape.
Rebecca Arend, MD, MPH: There are multiple other agents and pathways that look promising for the treatment of cervical cancer and other agents that are being looked at. We’ve seen some preliminary data that look exciting with drugs like cemiplimab and other PD-L1–targeted agents such as balstilimab, which has been given either as a single agent or in combination with the CTLA4 inhibitor zalifrelimab.
Additionally, we had seen efficacy with other immuno-oncology agents such as the anti–TIGIT [T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibitory motif] drug, which is tiragolumab. This is an extremely exciting time for patients with cervical cancer, and there’s a paradigm shift in our armamentarium for the treatment, both in frontline and in patients with recurrent cervical cancer.
Some of the pearls I want to share with my colleagues in the community who also see patients with cervical cancer are that there’s a real paradigm shift. Some of the questions that are going to be important for us to consider moving forward are: should we be testing for tissue factor to see how high that expression is? Is that potentially going to affect how we sequence these agents? If you have a high tissue factor, are you going to substitute tisotumab vedotin for taxane in combination with platinum in the first-line setting similar to the data that we saw presented at ESMO [European Society for Medical Oncology Congress]? That was in all comers, regardless of your H-score [histology score], and that’s an especially exciting area.
Additionally, data were published that looked at the addition of pembrolizumab in the first-line setting, plus or minus the addition of bevacizumab. We used the GOG 240-regimen, giving 6 cycles of chemotherapy, randomizing to plus or minus pembrolizumab and then physician’s choice as to whether you can use bevacizumab. That showed positive results with hazard ratios of around 0.6%, both for the progression-free survival and the overall survival, regardless of your PD-L1 status, but those with a PD-L1 score greater than 10 had the most benefit from this combination.
It will be interesting as we move forward to see how your PD-L1 status in the up-front setting affects your sequencing of drugs. If you’re PD-L1 positive, we may consider using a platinum doublet plus pembrolizumab maintenance, and then allowing us to use TV [tisotumab vedotin] as the second line. In other patients who received doublet plus bevacizumab followed by pembrolizumab, are we going to use the TV [tisotumab vedotin] in the third line? We have a lot more options, so it’s an extremely exciting time for patients with cervical cancer and for those of us treating these patients.
It will be interesting how we start to tailor therapy based on different biomarkers. We’ll start to look at when we first diagnose these patients: what biomarkers are going to help us determine when we’re going to give immunotherapy? Are we going to give immunotherapy to all comers despite a biomarker? Are we going to give an antibody-drug conjugate, such as TV [tisotumab vedotin], to all patients regardless of their expression of tissue factor? Based on the exciting data presented at ESMO in addition to the new FDA approval, a lot of us are going to be using TV [tisotumab vedotin] in clinical practice.
Transcript edited for clarity.