Transcript: Axel Hauschild, MD: There were 2 parts in the initial release of the data, which were published in June 2018, in the New England Journal of Medicine. The so-called part 1 and part 2, or group 1 and group 2, were patients either with locally advanced or metastatic cutaneous squamous cell carcinomas. They received cemiplimab not with a flat dose but with a dose that was based on their weight. We have the approval of 350-mg flat dose, given every 3 weeks, for cemiplimab. I think the reason for this was a study that was group 3 of the initial EMPOWER study. In group 3, there was a cohort of 350 mg every 3 weeks. And this is the current approval.
Neil D. Gross, MD, FACS: The indication trial for cemiplimab included locally advanced patients and patients with metastatic disease. They showed a very high response rate, and that’s what led to the approval of the drug, cemiplimab. What was very nice to see in the summer at the American Society of Clinical Oncology [ASCO] Annual Meeting in 2019 was that the long-term follow-up essentially bore out those results. So they were sustainable. The patients who received benefit continued to receive benefit, and the adverse-effect profile remained favorable. It confirmed what we were seeing clinically over the past years since approval.
Axel Hauschild, MD: If we talk about benefit and risk of cemiplimab for patients with advanced and metastatic cutaneous squamous cell carcinomas, I need to say that this is an outstandingly good result. We have a response rate of 50%. It appears that we have not reached the median of duration of these responses, so they are lasting. I have no idea how long they are lasting, but from my personal experience with patients, they are lasting very long. I have 2 patients with a complete response, and they stopped the treatment because the treatment was given for 2 years only in the pivotal clinical trial. They stopped and they are still in complete response, which is making me optimistic. But I’m an optimistic person in general, and the tolerability of cemiplimab in older patients is very good. It’s not seeming me that there is a difference between younger patients and older patients in the durability. Therefore, the ratio is rather good.
Dirk Schadendorf, MD: Cutaneous squamous cell carcinoma is induced by a lot of ultraviolet [UV] exposure. And it takes time, so we have an older patient population. Because of the UV exposure of the skin, we know that there is a lot of DNA damage creating a lot of tumor mutational burden. Therefore, tumor mutational burden is a good prerequisite for the immune system to detect these tumor cells to eliminate them. This is actually the scientific rationale why checkpoint inhibitors like cemiplimab now are at the frontline of treatment of advanced squamous cell carcinomas, because these checkpoint inhibitors are the best way to use the patient’s own immune system to eliminate the tumor.
Transcript Edited for Clarity