Case 1: Managing Patients With cSCC on Anti-PD-L1

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Ahmad Tarhini, MD, PhD:How should these patients be followed, Dr Wong, in the long term, in terms of imaging or follow-up in clinic?

Deborah J. Wong, MD, PhD:Certainly, a patient like the one Dr Emerick presented is at high risk for recurrence, either with the second primary recurrence of this tumor or even distant metastatic disease. In my clinic, I see them quite frequently. I see them at a minimum of once every 3 months, with a good clinical examination and with a low threshold to do imaging. For many patients, we will do routine imaging, at least for the first year, every few months. And of course, I always involve my multidisciplinary team, so patients continue their regular follow-up with dermatology, etcetera.

Ahmad Tarhini, MD, PhD:In terms of prognosis and a patient response, what are the expectations in terms of the durability of the responses, if we can compare, let’s say, a chemotherapy versus immune checkpoint inhibitors like cemiplimab and anti—PD-1 [anti–programmed cell death protein 1] antibodies?

Deborah J. Wong, MD, PhD:I think one of the beauties or one of the strengths of immune therapy is not only, as Dr McKean mentioned, the tolerability, but also the fact that unlike cytotoxic chemotherapy or targeted therapies, immunotherapy has the potential to be very durable in terms of its response. So in the EMPOWER-CSCC-1 study, patients were treated for 96 weeks. If they completed 96 weeks of therapy with ongoing response, they stopped therapy with ongoing monitoring. In several of those patients, we’ve seen ongoing responses, which is really amazing in an era where before immune therapies, before cemiplimab, we would expect maybe disease control with chemotherapy or targeted therapy on the order of months at best.

Ahmad Tarhini, MD, PhD:That sounds great. Now, let’s assume this patient is an organ transplant patient. This is a common problem. We all see it. How would you treat this patient, let’s say, in the first-line setting?

Meredith McKean, MD:There are some data that we have from melanoma with anti—PD-1s for patients who have received organ transplants. There have been patients who have tolerated immune therapies well. But I think it is a conversation to have with that patient, and with their transplant team, to discuss those risks. I think you’re probably, then, more likely to consider starting with chemotherapies. In a locally advanced patient, you could also still consider doing radiation with chemotherapy, and seeing if you can get a response before accepting the issues that may come with doing immune checkpoint inhibition.

Ahmad Tarhini, MD, PhD:OK. So it could be chemotherapy plus radiation, or chemotherapy alone.

Meredith McKean, MD:Right.

Ahmad Tarhini, MD, PhD:Or EGFR inhibitors. Have you treated a patient with anti—PD-1 antibodies who was an organ transplant patient? Have you had this experience?

Meredith McKean, MD:I personally have not. However, there are data, for example, for renal transplant patients who have been treated with anti—PD-1 therapy. There is a significant risk of rejection. But on a case-by-case basis, again, in a situation where patients have very few, if any, other options, it would be with a very careful discussion.

Th challenging thing is, of course, patients who were immunosuppressed probably are among those with the highest risk of recurrence, both locally recurrent as well as metastatic disease. So it’s definitely an area of need.

Ahmad Tarhini, MD, PhD:And there are interesting data obviously emerging from other skin cancers as well with combination therapy. So, local approaches plus systemic treatment.

Meredith McKean, MD:Right.

Ahmad Tarhini, MD, PhD:Which potentially could enhance the likelihood of their response as well. Although in this disease, 50% response rate, most of which are durable responses, is obviously exciting and life-changing for many of our patients.

One question about the testing, let’s say laboratory testing, before treatment for these patients: Do you test before every cycle? How often do you monitor, understanding the risk of immune-related adverse events, endocrinopathy? Sometimes patients are asymptomatic.

Meredith McKean, MD:I do tend to check standard labs before each dose, because this tends to be a population that is more elderly, and they have more comorbidities. There are some patients who I would monitor more closely. I have had patients for which I’ve spaced it out, to monthly lab checks and follow-up. A lot of it ends up being symptom-based as well; and then in checking thyroid studies and things like that, based on how they’re feeling, in addition to on a monthly basis as well.

Deborah J. Wong, MD, PhD:I agree. In my practice, for patients on cemiplimab every 3 weeks, 350 mg every 3 weeks, we will see our patients every time they’re in for treatment. We check routine labs, which include renal function, a liver panel, as well as a thyroid panel. One of the most common adverse effects of cemiplimab is fatigue, which is oftentimes left to the clinician to distinguish. Is this fatigue from an endocrinopathy like hypothyroidism, or is it fatigue that is an adverse effect of the drug, or something else entirely?

Transcript edited for clarity.