Cemiplimab for Advanced Basal Cell Carcinoma Ineligible for Surgery or Radiation

In this video, Soo Park, MD, University of California San Diego, discusses the use of cemiplimab therapy for patients with advanced basal cell carcinoma that are ineligible for additional surgery or radiation and who cannot tolerate or have progressed on a hedgehog inhibitor.

Transcript:

My name is Soo Park. I'm a medical oncologist at the University of California San Diego, and I focus on non-melanoma skin cancers. Today I want to talk about cemiplimab which is a PD-1 inhibitor that is approved for patients with advanced basal cell carcinoma who are not eligible for additional surgery or radiation, and who cannot tolerate or have progressed on a hedgehog inhibitor.

This drug was approved by the FDA in February of 2021, based on study 1620. It is important to note that regular approval was for locally advanced disease while accelerated approval was granted for metastatic disease. Study 1620 included a total of 112 patients. 84 with locally advanced disease and 28 with metastatic disease. All patients had disease progression, intolerance, or no measurable response on a hedgehog inhibitor. Nearly three fourths of the patients had disease progression on a prior hedgehog inhibitor. And certain patients were not eligible for this study, including those with autoimmune disease who were on immunosuppressive therapy and solid organ transplant recipients.

Patients in this study received cemiplimab for almost two years. For patients with locally advanced disease, the objective response rate was about 31% with 6% of those being complete responses, meaning that all the target lesions had disappeared and there were no new lesions, and 25% were partial responses. 79% of patients continued to have responding disease lasting six months or longer. The objective response rate was a little bit lower at 21% for patients with metastatic disease. And all these responses were partial responses. But still all the responses in metastatic disease were ongoing lasting six months or longer.

All in all, while responses can be delayed with this drug, the durability of response is quite notable, and the toxicity profile is consistent with known immune-related adverse events. It would be interesting to study cemiplimab in the first line setting prior to hedgehog inhibitor exposure.

In relation to the question that was associated with this vignette, there is no specific testing that is required prior to starting treatment with cemiplimab. In this study 1620, there was no association between response and tumor mutational burden, and PDL-1 expression. Patients with low PDL-1 expression, defined as less than 1%, had similar clinical benefit when compared to those with PDL-1 expression, greater than or equal to 1%. In summary, cemiplimab is an immuno-therapeutic option for advanced basal cell carcinoma when a hedgehog inhibitor is not appropriate.