Real-World Management of Patients on Cemiplimab

Anna C. Pavlick, DO:My experience with cemiplimab has been quite extensive, not only now that it’s been FDA approved but also because I was 1 of the investigators in the phase II study that helped get this drug FDA approved. I’ve been able to watch patients go from having socked in disease, or metastatic disease, to having disease that’s now regressed and controllable. Some patients will have complete resolution of their disease. Some patients will have their disease shrink up and almost become inactivated, where they’ll continue to have disease on their scans, and they’ll just never progress. Many times you have to make a decision to take people off cemiplimab because they’ve had enough, since we aren’t able to gauge that amount. Or they develop toxicity, and we decide it’s time to take them off. But those responses remain consistently stable.

The toxicities with cemiplimab are very similar to the toxicities that we see with other anti-PD-1 [programmed cell death protein 1] agents. There’s fatigue, rash, and itching. There might be diarrhea in a small percentage of patients. We worry about drug-induced hepatitis and nephritis since this drug also gets metabolized through the liver and the kidneys. Sometimes patients will also get hypothyroidism. But that’s easily managed with giving the patients levothyroxine for replacement.

The endocrinopathies in general that occur are secondary to anti—PD-1 therapy appear to be the adverse events that happen that appear to be lifelong. Patients need to understand that if they do develop an endocrinopathy, the treatment of it would be required for the rest of their lives. All the other toxicities that we see are, for all intents and purposes, treatable and resolvable.

How do we pick patients who are candidates for immunotherapy? I think the key is having a good history. You want to make sure patients don’t have any horrific underlying autoimmune diseases. Whenever you give any type of immunotherapy, you’ve got to know that you’re going to exacerbate that underlying disease. If I have a patient who has really uncontrolled ulcerative colitis, I have to think long and hard about whether patients like that would get this drug.

However, you need to have the conversation with the patient. Just because they have underlying autoimmune diseases or underlying colitis, doesn’t mean that it’s a knee-jerk response of, ”Oh, no, you can’t get this drug.” You have to talk about the risk-to-benefit ratio. Say you’ve got someone who’s got a diffusely metastatic disease and is going to die from their disease. You have to weigh what’s the risk of giving them some toxicity that may require tweaking their underlying medicines or watch them very closely to make sure they don’t either get diarrhea or a flare of their arthritis because they have RA [rheumatoid arthritis].

In general, most people, when they weigh dying from cancer versus dealing with toxicity from drugs will sit down and say, “I think we should give it a chance.” This is because they understand that although they might have an exacerbation of their underlying disease or the underlying symptoms of their disease, there’s always the hope that they are going to develop that long-term response, and durability of response, so that they can come off these drugs and still remain alive with their cancer essentially under control.

Transcript edited for clarity.

Case: A 74-Year-Old Male With Recurrent Metastatic CSCC

November 2017

• A 74-year-old male from Florida, with history of multiple resections of CSCC on neck, back and shoulders presents with new deep lesion that exhibited perineural invasion and c/o palpable left axillary mass
• Imaging confirmed 6cm left axillary nodal conglomerate
• Patient treated with neoadjuvant cisplatin/5FU for 3 cycles
• Surgical resection of primary lesion; Lymphadenectomy revealed CSCC involvement in 12 out of 16 resected lymph nodes

May 2018

• Follow-up scans revealed early disease progression with multiple pulmonary nodules
• Patient started on carboplatin/paclitaxel for 3 cycles

November 2018

• Repeat imaging showed disease progression in pulmonary nodules and multiple lymphadenopathies; mediastinal, left and right axillary; bone metastases
• Patient started on cemiplimab for 3 cycles

February 2019

• Reimaging PET-CT revealed reduction in size and metabolic activity of right and left axillary, and mediastinal lymphadenopathies; pulmonary nodules had considerable reduction in size and were no longer substantial