Cemiplimab in Locally Advanced Cutaneous Squamous Cell Carcinoma

Get Permission

As reported in The Lancet Oncology by Migden et al, a phase II trial has shown activity of cemiplimab in patients with locally advanced cutaneous squamous cell carcinoma. The trial supported the September 2018 U.S. Food and Drug Administration approval of cemiplimab in this setting. In this report, data are updated though October 2018.

Study Details

In the trial, 78 patients who were not candidates for surgery or radiotherapy were enrolled from 25 sites in Australia, Germany, and the United States between June 2016 and April 2018. Patients were treated with cemiplimab at 3 mg/kg intravenously over 30 minutes every 2 weeks for up to 96 weeks. The primary endpoint was objective response on independent central review using Response Evaluation Criteria in Solid Tumors, version 1.1, for radiologic scans and World Health Organization criteria for medical photography. Data cutoff for the current analysis was in October 2018.


  • Objective response was observed in 44% of patients.
  • Median duration of response was not reached.


Median duration of follow-up at data cutoff was 9.3 months. Objective response was observed in 34 of 78 patients (44%; 95% confidence interval = 32%–55%), with complete response seen in 10 (13%). Stable disease was observed in an additional 28 patients (36%). Median duration of response had not been reached at data cutoff; the longest response at that time was 24.2 months and was ongoing.  

Median progression-free and overall survival had not been reached at time of analysis. Estimated 12-month progression-free survival was 58%, and estimated 12-month overall survival was 93%.

Adverse Events

The most common grade 1 or 2 adverse events were fatigue (41%), diarrhea (27%), and pruritus (27%). Grade 3 or 4 adverse events occurred in 34 patients (44%), with the most common being hypertension (8%) and pneumonia (5%). Serious adverse events occurred in 23 patients (29%), with the most common being pneumonitis (4%). Treatment-related adverse events resulted in discontinuation of treatment in 8% of patients. One death, due to aspiration pneumonia, was considered related to treatment.

The investigators concluded, “Cemiplimab showed antitumour activity and an acceptable safety profile in patients with locally advanced cutaneous squamous cell carcinoma for whom there was no widely accepted standard of care.”

Michael R. Migden, MD, of the Departments of Dermatology and Head and Neck Surgery at The University of Texas MD Anderson Cancer Center, is the corresponding author for The Lancet Oncology article.

Disclosure: The study was funded by Regeneron Pharmaceuticals and Sanofi. For full disclosures of the study authors, visit