Transcript: Neil D. Gross, MD, FACS: Many patients with locally advanced cutaneous squamous cell carcinoma are older. They tend to have a lot of comorbidities, and surgery can be very taxing for them. Some patients are just not good surgical candidates. Historically for those patients, we would offer some sort of palliative treatment, oftentimes an EGFR inhibitor like cetuximab. And it could show benefit but often very temporary benefit. Other more aggressive systemic therapies, or even locally aggressive radiation therapy in the palliative setting, have very mixed results.
Axel Hauschild, MD: The Food and Drug Administration [FDA] and European Medicines Agency approvals are for cemiplimab, a new programmed cell death protein 1 [PD-1] antibody, which was tested in patients with locally advanced and metastatic cutaneous squamous cell carcinomas. The label says this is a drug for patients who are not surgical candidates. It’s very important for curative surgery or curative radiotherapy, which means that, again, it’s an interdisciplinary discussion, which leads to the infusion of cemiplimab in most of those patients. We had the approval in the United States half a year before we got approval in Europe. Since July 2019, we are very happy that we have an approved drug that we can give right away in Germany, because there’s no delay in the approval and reimbursement.
Neil D. Gross, MD, FACS: The approval of cemiplimab has completely revolutionized the treatment of patients who are poor surgical candidates or have metastatic disease. It’s turned it on its end. It’s now, I think, what we turn to first for patients in this setting. The adverse effects tend to be much fewer than other systemic options, and it works better.
Axel Hauschild, MD: The primary goal of treatment with cemiplimab for me is to achieve a good response, and ideally a complete response, which is long lasting. It’s too early to talk about cure for those patients, but I think we can cure a substantial fraction of patients, because the learning session we got from metastatic melanoma shows we have 5-year survival rates of 50% right now here at the European Society for Medical Oncology [ESMO] meeting. Therefore, why not go for the goal of cure in the future? Right now the goals are the prolongation of relapse-free survival and to achieve long-lasting responses—in particular, a reasonable number of complete responses.
In addition, this is with good tolerability of the drug. That is, I think, a very important issue, particularly in older patients. This is 1 of the big advantages of cemiplimab, because the data look really good, because we have only 10% of patients who step off treatment. Also, it’s a population that is rather old.
Transcript Edited for Clarity