Basal Cell Carcinoma

Cemiplimab-rwlc ror Locally Advanced and Metastatic Basal Cell Carcinoma

Cemiplimab-rwlc ror Locally Advanced and Metastatic Basal Cell Carcinoma

February 9, 2021

Patients with locally advanced basal cell carcinoma, not amenable to further surgical resection or radiotherapy, and have progressed on a hedgehog inhibitor, are candidates for immunotherapy with Cemiplimab.  On February 9, 2021 the FDA granted approval for Cemiplimab in this setting.  It was based off results from Study 1620.  112 patients with advanced basal cell carcinoma, 28 of whom had metastatic disease, were treated with Cemiplimab 350 mg every 3 weeks for up to 93 weeks or until disease progression or unacceptable toxicity.  The median age was 70. 67% of patients were male and 68% were Caucasian.  83% had prior surgical resection and 50% had prior radiotherapy.  Patients with metastatic disease were 5 years younger on average.  Efficacy outcomes were objective response rate and duration of response.  Patients who had advanced basal cell carcinoma, objective responses were seen in 29% of patients, with a complete response in 6%. The median duration of response was not reached with 79% of responders maintaining a response for at least 6 months. Of the 20 patients with metastatic disease, objective responses were observed and 21%. The median duration of response was not reached. 100% of responders maintained response for at least 6 months.

Reference:

cemiplimab-rwlc for locally advanced and metastatic basal cell carcinoma

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-locally-advanced-and-metastatic-basal-cell-carcinoma

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