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Cemiplimab Post-Treatment Considerations

Insights From: Robert L. Ferris, MD, PhD, UPMC Hillman Cancer Center; Anna C. Pavlick, DO, NYU Langone Hospitals; Todd E. Schlesinger, MD, FAAD, FASMS, Dermatology & Laser Center of Charleston
Published: Tuesday, Feb 26, 2019



Transcript:


Todd E. Schlesinger, MD, FAAD, FASMS: The follow-up for patients who have received a favorable response with cemiplimab is sort of unknown. I think it’s still a gestalt. We’re still looking for that answer. Those patients are going to be continued to be followed regularly for signs of disease recurrence, or disease progression, if they’ve had a complete response, which we’d always hope for. We’re looking for that to make sure that tumor isn’t coming back, we’re not seeing the tumor come back elsewhere. So as far as intervals go, I typically wouldn’t see a patient like that any less than every 3 months, and oftentimes they may be seen monthly after they’ve completed their course, or even more often. It really depends, again, on that patient.

For example, a patient who’s immunocompromised, they would really want to see them quite regularly, especially if they’ve had a solid organ transplant, a lung transplant, kidney transplant, heart transplant—any patient that’s on immunosuppressant medications, we’d want to see them quite frequently to just keep after any squamous cell carcinomas that may recur. And, of course, also be seen by the multidisciplinary team.

Robert L. Ferris, MD, PhD: If a patient has been treated with cemiplimab, then obviously the key initial decision making is based on their response. Fortunately, the response rate approximating 50% indicates that at least half of the patients will remain on therapy. Now adding stable disease adds a population because at present they’re, to get cemiplimab, the treatment team tends to feel that there’s not another effective therapy option. So even stable disease is an appropriate population to continue therapy. So over half of the patients who start on cemiplimab will likely stay on it, whether they have objective tumor shrinkage or simply disease stabilization, simply because at this point in time we don’t have any better options.

Now the clinical trials with the expansion cohorts in this phase I experience had on average 1 prior line of therapy. Some had 0, some had 2, but primarily these patients had a single prior line of therapy. Now there aren’t that many more available, but if a partial response were seen or disease stabilization, that permits the treatment team then to begin to reevaluate whether a low morbidity surgical procedure could be utilized, whether with a partial response radiation could be brought back into it, or potentially chemotherapy where that was not entertained initially.

Anna C. Pavlick, DO: While patients are being treated, patients get seen every 3 weeks while they get their infusions. We look at their laboratory work, we assess them for toxicity. When patients come off therapy, we routinely see them every 3 months. If they’ve had adverse effects during therapy, we may see them more frequently. But, routinely, patients do exceedingly well and once we know that their disease has responded, the rule of thumb, at least in my office, is to see these patients every 3 months for at least the first 2 years.

Fortunately, cemiplimab is coming to market at a good time because most oncologists are very familiar with managing and identifying the adverse effects of anti–PD-1 [anti-programmed cell death protein 1] therapy. So this is an anti–PD-1 agent. The toxicity is very similar to those of the other anti–PD-1 agents that are in use for lung cancer and melanoma. So the thing that doctors really need to look for are itching and rash, possibly fatigue, maybe some diarrhea. We essentially tell patients that these are proinflammatory drugs. They cause the itises. These are my itis drugs. So, if you can put an itis at the end of any word, like dermatitis, colitis, hepatitis, pneumonitis, these are the things that you need to be astutely aware of as a potential adverse] effect of these medicines.

Robert L. Ferris, MD, PhD: At the present time if a patient experiences recurrence or relapse on cemiplimab, then the treatment team needs to assess whether there is any surgical option, whether a debulking procedure with then radiation might be useful. There’s reason to believe that PD-1 inhibitors may be particularly well suited to enhance radiation therapy, because radiation can trigger the ligand PD-L1 on the tumors and may actually make the cemiplimab more effective. But also, we have new clinical trials in combinations, which will build on PD-1 inhibitors, that need to be done for this population.

Anna C. Pavlick, DO: Pseudoprogression can be difficult to sort out. It’s not usually seen with single agents. It’s usually much more commonly seen with combination therapy and therapies that include CTLA-4 [cytotoxic T-lymphocyte–associated protein 4]. However, every once in a while you do see pseudoprogression with single agent PD-1 therapy. And my rule of thumb is if the patient looks good and the scan looks good, it’s good. If the patient is declining clinically and the scan looks bad, that’s not pseudoprogression, that’s disease progression. But, if the patient looks good and is feeling good, and the scan looks bad, that’s pseudoprogression because on your next scan, looking at the patient clinically and knowing that they are getting better physically, that scan is just taking a little bit longer to show the response, and it will.

We know that once you get 1 skin cancer, you’re at risk of getting other skin cancers for the simple reason that patients who get skin cancer are patients who have had way too much sun exposure over the course of their life. And, once you have 1 skin cancer, you’re at a risk of getting recurrent or other squamous cell cancers. And, again, we don’t know if you’ve been treated with cemiplimab if that essentially negates your potential to get other cutaneous squamous cells down the line. We don’t know that. But those patients are still at risk of developing basal cell, or melanoma or Merkel cell because of, again, excessive sun exposure.

We tell patients to practice safe sun practices, such as wide-brimmed hats, usually vigorous amounts of sunscreen, using sun protective clothing, trying to stay out of the sun between the hours of 10 and 4. But most importantly, in addition to seeing their surgeon and/or oncologist, to really be very diligent about going back to their dermatologist for a total body skin exam to make sure that they’re not developing any other type of skin cancer.

Transcript edited for clarity.
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Transcript:


Todd E. Schlesinger, MD, FAAD, FASMS: The follow-up for patients who have received a favorable response with cemiplimab is sort of unknown. I think it’s still a gestalt. We’re still looking for that answer. Those patients are going to be continued to be followed regularly for signs of disease recurrence, or disease progression, if they’ve had a complete response, which we’d always hope for. We’re looking for that to make sure that tumor isn’t coming back, we’re not seeing the tumor come back elsewhere. So as far as intervals go, I typically wouldn’t see a patient like that any less than every 3 months, and oftentimes they may be seen monthly after they’ve completed their course, or even more often. It really depends, again, on that patient.

For example, a patient who’s immunocompromised, they would really want to see them quite regularly, especially if they’ve had a solid organ transplant, a lung transplant, kidney transplant, heart transplant—any patient that’s on immunosuppressant medications, we’d want to see them quite frequently to just keep after any squamous cell carcinomas that may recur. And, of course, also be seen by the multidisciplinary team.

Robert L. Ferris, MD, PhD: If a patient has been treated with cemiplimab, then obviously the key initial decision making is based on their response. Fortunately, the response rate approximating 50% indicates that at least half of the patients will remain on therapy. Now adding stable disease adds a population because at present they’re, to get cemiplimab, the treatment team tends to feel that there’s not another effective therapy option. So even stable disease is an appropriate population to continue therapy. So over half of the patients who start on cemiplimab will likely stay on it, whether they have objective tumor shrinkage or simply disease stabilization, simply because at this point in time we don’t have any better options.

Now the clinical trials with the expansion cohorts in this phase I experience had on average 1 prior line of therapy. Some had 0, some had 2, but primarily these patients had a single prior line of therapy. Now there aren’t that many more available, but if a partial response were seen or disease stabilization, that permits the treatment team then to begin to reevaluate whether a low morbidity surgical procedure could be utilized, whether with a partial response radiation could be brought back into it, or potentially chemotherapy where that was not entertained initially.

Anna C. Pavlick, DO: While patients are being treated, patients get seen every 3 weeks while they get their infusions. We look at their laboratory work, we assess them for toxicity. When patients come off therapy, we routinely see them every 3 months. If they’ve had adverse effects during therapy, we may see them more frequently. But, routinely, patients do exceedingly well and once we know that their disease has responded, the rule of thumb, at least in my office, is to see these patients every 3 months for at least the first 2 years.

Fortunately, cemiplimab is coming to market at a good time because most oncologists are very familiar with managing and identifying the adverse effects of anti–PD-1 [anti-programmed cell death protein 1] therapy. So this is an anti–PD-1 agent. The toxicity is very similar to those of the other anti–PD-1 agents that are in use for lung cancer and melanoma. So the thing that doctors really need to look for are itching and rash, possibly fatigue, maybe some diarrhea. We essentially tell patients that these are proinflammatory drugs. They cause the itises. These are my itis drugs. So, if you can put an itis at the end of any word, like dermatitis, colitis, hepatitis, pneumonitis, these are the things that you need to be astutely aware of as a potential adverse] effect of these medicines.

Robert L. Ferris, MD, PhD: At the present time if a patient experiences recurrence or relapse on cemiplimab, then the treatment team needs to assess whether there is any surgical option, whether a debulking procedure with then radiation might be useful. There’s reason to believe that PD-1 inhibitors may be particularly well suited to enhance radiation therapy, because radiation can trigger the ligand PD-L1 on the tumors and may actually make the cemiplimab more effective. But also, we have new clinical trials in combinations, which will build on PD-1 inhibitors, that need to be done for this population.

Anna C. Pavlick, DO: Pseudoprogression can be difficult to sort out. It’s not usually seen with single agents. It’s usually much more commonly seen with combination therapy and therapies that include CTLA-4 [cytotoxic T-lymphocyte–associated protein 4]. However, every once in a while you do see pseudoprogression with single agent PD-1 therapy. And my rule of thumb is if the patient looks good and the scan looks good, it’s good. If the patient is declining clinically and the scan looks bad, that’s not pseudoprogression, that’s disease progression. But, if the patient looks good and is feeling good, and the scan looks bad, that’s pseudoprogression because on your next scan, looking at the patient clinically and knowing that they are getting better physically, that scan is just taking a little bit longer to show the response, and it will.

We know that once you get 1 skin cancer, you’re at risk of getting other skin cancers for the simple reason that patients who get skin cancer are patients who have had way too much sun exposure over the course of their life. And, once you have 1 skin cancer, you’re at a risk of getting recurrent or other squamous cell cancers. And, again, we don’t know if you’ve been treated with cemiplimab if that essentially negates your potential to get other cutaneous squamous cells down the line. We don’t know that. But those patients are still at risk of developing basal cell, or melanoma or Merkel cell because of, again, excessive sun exposure.

We tell patients to practice safe sun practices, such as wide-brimmed hats, usually vigorous amounts of sunscreen, using sun protective clothing, trying to stay out of the sun between the hours of 10 and 4. But most importantly, in addition to seeing their surgeon and/or oncologist, to really be very diligent about going back to their dermatologist for a total body skin exam to make sure that they’re not developing any other type of skin cancer.

Transcript edited for clarity.
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