FDA Grants Cemiplimab Breakthrough Therapy Designation for Cutaneous SCC

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CSCC has the second highest mortality rate among skin cancers after melanoma.
CSCC has the second highest mortality rate among skin cancers after melanoma.

The US Food and Drug Administration (FDA) granted Breakthrough Therapy designation to cemiplimab for the treatment of adult patients with metastatic cutaneous squamous cell carcinoma (CSCC) and locally advanced and unresectable CSCC.1

CSCC has the second highest mortality rate among skin cancers after melanoma. Although it has good prognosis if detected early, treatment becomes very difficult upon disease progression.

The FDA granted Breakthrough Therapy designation based on data from a previously reported phase 1 study (ClinicalTrials.gov Identifier: NCT02383212) that evaluated the effect of cemiplimab alone and in combination with other anticancer medications in patients with advanced malignancies.

Patients achieved an investigator-assessed overall response rate (ORR) of 46.2% (12 of 26 patients), including 1 unconfirmed partial response, 9 partial responses, and 2 complete responses. The disease control rate was 69.2% (18 of 26 patients, including 12 ORR and 6 stable diseases). At the data cutoff date with a median follow-up of 6.9 months, neither median progression-free survival nor overall survival were reached.

The most commonly occurring adverse event (AE) was fatigue. The most frequently reported grade 3 or higher AEs were arthralgia, maculopapular rash, asthenia, and AST/ALT elevations.

RELATED: Benefit of Binimetinib Addition to Encorafenib Confirmed in Melanoma

Cemiplimab, an investigational human monoclonal antibody targeting PD-1, is being further evaluated in the stage 2 EMPOWER-CSCC1 study. The trial is currently enrolling patients with metastatic, locally advanced, and unresectable CSCC.


  1. Regeneron and Sanofi announce cemiplimab (REGN2810) has received FDA Breakthrough Therapy Designation for advanced cutaneous squamous cell carcinoma [news release]. Tarrytown, NY, and Paris, France: PRNewswire; September 8, 2017. https://prnmedia.prnewswire.com/news-releases/443185823.html?tc=PRNJ_email_html_headlines. Accessed September 8, 2017.

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