News & Perspective

FDA approval for cemiplimab, the first treatment for advanced CSCC

1 year ago, OP Editor

Cutaneous Squamous Cell Carcinoma (CSCC) is the second most common skin cancer in the US, with an annual incidence of 700,000 cases.1,2 The US Food and Drug Administration (FDA) has recently approved cemiplimab for the treatment of locally advanced or metastatic CSCC in patients who are not candidates for curative surgery or curative radiotherapy.1 Cemiplimab is the sixth immunotherapy drug targeting the PD-L1/PD-1 pathway to be approved by the FDA, as well as the first treatment approved specifically for advanced CSCC.1

CSCC is a common form of skin cancer, second to basal-cell carcinoma in terms of incidence.2 In a large majority of patients, CSCC can be cured with surgical interventions.2 However, when the tumor spreads to deeper layers of the skin or adjacent tissues, the disease may reach an incurable state.3. Locally advanced or metastatic CSCC are life-threatening conditions that would no longer benefit from curative surgery or radiation.2 Prior to the approval of cemiplimab, there were no approved treatments for this subset of patients.

The FDA has recently approved cemiplimab for the treatment of locally advanced and metastatic CSCC, based on promising results in the clinical trials.1 “By following the science, we identified early on that advanced CSCC was a promising target for investigation [with cemiplimab],” said Dr. Israel Lowy, Vice President of Global Clinical Development and Head of Translational Science and Clinical Oncology, Regeneron Pharmaceuticals, Inc.3

The approval of cemiplimab is based on a combined analysis of two clinical trials: An open-label, multicenter, non-randomized phase 2 clinical trial (EMPOWER-CSCC-1, study 1540), and expansion cohorts from an open-label, multicenter, non-randomized phase 1 trial (study 1423).2,4

A total of 108 patients were included in the final efficacy analysis, 75 with metastatic CSCC and 33 with locally advanced CSCC.1,4 These two studies represent the largest prospective data set in advanced CSCC. Patients were given intravenous cemiplimab (3mg per every kilogram of body weight) every 2 weeks and were assessed for a response every 8 weeks.2,4 The primary end-point of the study was confirmed objective response rate (ORR) as assessed by independent central review (ICR), as well as ICR-assessed duration of response.2,4

With 8.9 months as the median duration of follow up in the combined analysis, the ORR with cemiplimab was 47.2% (95% CI: 37.5%-57.1%).4 The complete response rate was 3.7% and the partial response rate was 43.5%.4

Safety was also inspected in all patients receiving treatment. The most common adverse reactions were fatigue, rash, and diarrhea.4 Serious adverse reactions that occurred in ≥2% patients were cellulitis, sepsis, pneumonia, pneumonitis, and urinary tract infection.5

“Today’s FDA decision is great news for patients with advanced CSCC, who previously had no approved treatment options. This is especially true because these patients are no longer candidates for curative surgery or radiation,” said Dr. Michael R. Migden, a researcher in CSCC clinical program and Professor in the Departments of Dermatology and Head and Neck Surgery at The University of Texas MD Anderson Cancer Centre, US.3


1. FDA approves first treatment for advanced form of the second most common skin cancer. U.S. Food & Drug Administration. 2018 (Accessed October 19, 2018, at

2. Midgen MR, Rischin D, Schmults CD, et al. PD-1 Blockade with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma. N Engl J Med. 2018; 379:341-351


4. LIBTAYO (cemiplimab-rwlc). US Prescribing Information. Sept 2018.

5. FDA Approves Libtayo (cemiplimab-rwlc) as First and Only Treatment for Advanced Cutaneous Squamous Cell Carcinoma. PR Newswire. 2018 (Accessed October 19, 2018, at


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