Transcript: Dirk Schadendorf, MD: After seeing the EMPOWER study results in Europe, we were eagerly waiting for approval of cemiplimab because we believe that this is a new standard. We have not been able to treat a large subset of our older-patient population, which has some comorbidities because cisplatin or platinum-derived compounds have been used as standard of care in former times, precluding a lot of those patients for systemic treatment at all. Now with cemiplimab being available since this summer, I think we have a completely new game, and this is a new standard of care.
Axel Hauschild, MD: We were very happy when we had a clinical trial on cemiplimab, and our first patient was an 85-year-old man who got several surgeries for metastatic cutaneous squamous cell carcinomas and an irradiation. In the irradiation field, he had a huge exophytic tumor and pain. This patient had, in addition, several lymph node metastases in the axilla and also in the mediastinum. And this was our first patient.
After just 1 infusion we saw the tumor shrinking, which was for us the target lesion. After 3 infusions the tumor almost disappeared, and this is a patient who was still in complete response. We stopped the treatment after 2 years, and now he is in complete response for 9 months after stopping the treatment. And he is doing very well. He has had some fatigue. But he was 85 years old. Meanwhile, he’s 88 years old now, and he’s still in good shape. And this is very nice if the very first patient in a clinical trial is a rapid responder. We have other patients who were doing as well.
Neil D. Gross, MD, FACS: At The University of Texas MD Anderson Cancer Center we have a multidisciplinary approach to treating these patients, as we do with all patients. These patients really require a multidisciplinary team. Again, they tend to be older patients, a lot of them with comorbidities, and they have a life-threatening disease. Cemiplimab has changed how we manage these patients. Since its approval it has become our first-line treatment for patients with unresectable or metastatic disease. And the reason is our clinical experience, both on trials and off trials, has been very favorable with it. We’ve seen really amazing responses to treatment, both on trial and off trial.
Dirk Schadendorf, MD: We are discussing all these patients with advanced squamous cell carcinoma in our interdisciplinary tumor board. We like to hear and to learn about the view of our radiation oncologists and our surgeons. In the entire concept of treating these patients, cemiplimab is a new standard, obviously, with the power to regress the tumor potently. My personal experience using cemiplimab is very favorable. The safety profile of the drug, like other programmed cell death protein 1 [PD-1] antibodies, is extremely good. I think this is important to stress because many of our patients with advanced squamous cell carcinoma are older patients, even in their 70s and 80s, so that’s also a reflection of the clinical trial population, which has been treated. What we have learned is that even if the patient is 80 years old, or even older, that does not preclude treatment. In contrast, I think it’s important that older patients are also exposed to the drug and benefit from this kind of drug, in order to experience their quality of life by shrinking the tumor and controlling the tumor for a long period of time.
Transcript Edited for Clarity