PD-1 blockade with cemiplimab has antitumor activity with adverse events similar to other PD-1 inhibitors.

  • Major finding: PD-1 blockade with cemiplimab has antitumor activity with adverse events similar to other PD-1 inhibitors.

  • Concept: Cemiplimab achieves responses in 48% of patients, including those with metastatic disease.

  • Impact: Cemiplimab may be effective for the treatment of patients with advanced cutaneous squamous cell carcinoma.

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Patients with cutaneous squamous cell carcinoma have a high mutation burden and immunosuppression is associated with an increased risk of disease, suggesting the potential for successful immunotherapy. Migden, Rischin, and colleagues evaluated the safety and efficacy of the anti–PD-1 monoclonal antibody cemiplimab in a phase I study in an expansion cohort of 26 patients with locally advanced or metastatic cutaneous squamous cell carcinoma and in a phase II study cohort of 59 patients with metastatic disease. The primary endpoint of the phase I study was the safety and side-effect profile of cemiplimab, and the primary endpoint of the phase II was the response rate. Secondary endpoints of both studies included the duration of response. In the phase I cohort, objective responses were observed in 13 of 26 patients (50%), and the duration of response exceeded 6 months in 7 of 13 responding patients. In the phase II cohort, objective responses were achieved by 28 of 59 patients (47%), including 4 complete and 24 partial responses. The median duration of response was not reached, but 16 of the 28 responding patients had responses that lasted more than 6 months. Adverse events were consistent with those seen with other PD-1 inhibitors. In the phase II cohort, serious adverse events occurred in 36% of patients, leading to treatment discontinuation in 7% of patients. Taken together, the results from these phase I and II trials demonstrate that PD-1 inhibition with cemiplimab may be effective for the treatment of patients with advanced cutaneous squamous cell carcinoma, including patients with metastatic disease.

Migden MR, Rischin D, Schmults CD, Guminski A, Hauschild A, Lewis KD, et al. PD-1 blockade with cemiplimab in advanced cutaneous squamous-cell carcinoma. N Engl J Med 2018 Jun 4 [Epub ahead of print].

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