Experience With Immunotherapy in cSCC

Transcript:

Todd E. Schlesinger, M.D., FAAD: For cemiplimab, the dosing schedule is actually quite simple. It’s given as a 30-minute infusion every three weeks. There’s really only one dose that you can give. It’s an IV [intravenous] infusion. It doesn’t take very long to deliver the medication to the patient. It’s a full vial of medication that’s delivered in either a 100 milliliter IV bag or maybe 500 milliliter, depending on how the doctor chooses to infuse it. The patient generally doesn’t feel much during the infusion. They sometimes may feel something, maybe that it feels a little different. But most of the time the adverse effects, if they were going to occur, don’t occur until the second, third or fourth infusion that they have.

So as far as the patients go, it’s not a huge barrier. They do have to go into an infusion center to have the infusions done, or an oncologist or a dermatologist’s office that does infusions. That’s one thing, they have to come in and be monitored while they’re there, to be carefully watched to make sure they don’t have immune-related adverse effects that could occur. During the infusions, it’s possible that the immune system can wake up even during the infusion and they can have a adverse effect that occurs more immediately, but it’s more likely that it would occur later. As far as that being a barrier, coming for the IV, it’s a short infusion so it’s not a huge barrier to a patient. That’s nice to see.

What’s the response with cemiplimab? The study showed that the response rate is about 50%. If you look at all the people who responded partially and all the people who responded all the way or had complete responses, that’s about half. So I tell people that about half of the time you’ll see a response, and that’s a good thing. It’s actually much better than some of the older therapies that we had, in which that percentage would be in the 20s or 30s. So actually, it is a better therapy as far as that goes, and that’s why it’s sort of risen to being recommended first-line as a treatment for locally advanced in a metastatic squamous cell carcinoma.

How do the data that we’re seeing in the real world compare to clinical trials? I think it would be very similar. I think the trials have continued to show benefit over time, the real-world outcomes have been very similar. There haven’t been really any more data published on that since some data were released last summer in a major oncology meeting. We don’t really have more long-term real-world data. In my own experience, the patients have done just as well as they have in the trials as far as the outcomes, and in a general sense it’s very similar. It’s nice to see that the real-world data in just my personal experience match the trial data.

As far as adverse effects go, the serious adverse effect rate is actually pretty low. We talked about more serious adverse effects being maybe in the 1% to 5% range of patients. Most people who have adverse effects are mild-moderate, and they’re typically easily managed with simple treatments like systemic cortisone, prednisone, sometimes even a topical steroid, or sometimes management by an endocrinologist for their thyroid, which can be made abnormal by the treatment.

However, an abnormal thyroid test is not necessarily a reason to stop the medication because that can be managed. With other side effects such as diarrhea, or if they have autoimmune pneumonitis, that has to be addressed. They all have to be addressed seriously. But for severe side effects involving the lungs, the kidneys, or the GI tract, the gastrointestinal system, if they’re very severe the patient can’t take that medicine any more. But for thyroid, they continue to take their medication in some cases, even though their thyroid abnormalities are being managed. So some side effects you can treat through, and other side effects, you can’t.

Transcript Edited for Clarity