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Cutaneous squamous cell carcinoma (CSCC) is the second most frequent malignant skin cancer, with an increasing worldwide incidence. Cemiplimab is a human monoclonal antibody directed against programmed cell death-1 receptor that acts by blocking T-cell inactivation. It is the first drug approved for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation. The aim of this review is to analyze the mechanism of action, including pharmacokinetic and pharmacodynamic properties, clinical efficacy, safety, and tolerability of cemiplimab for squamous cell carcinoma. The introduction of immune checkpoint inhibitors has revolutionized the therapeutic scenario of advanced skin cancers. Many challenges regarding the use of cemiplimab for locally advanced and metastatic CSCC still exist. The use of combination treatments, including the association of different immune checkpoint inhibitors, could be a strategy to increase treatment response, reducing the possibility of therapeutic failure. Also, different schemes of treatment or dose adjustments should be considered in order to reduce toxicity, avoiding treatment discontinuation and increasing patient´s quality of life.

Cemiplimab for the treatment of advanced cutaneous squamous cell carcinoma