Trial Result Confirms the Advantage of Cemiplimab for Skin Cancer at High Risk of Recurrence

We usually don’t feature nonmelanoma skin cancer articles here, but we thought you might be interested in what’s happening in that world.
Patients with cutaneous squamous cell carcinoma treated with cemiplimab (brand name LIBTAYO) had longer disease-free survival than patients treated with a placebo. After two years, the drug was able to prevent skin cancer recurrence in the area of the primary lesion and distant spread. This effect lasted for at least five years – the present duration of the trial.
The results come from a randomized phase 3 trial called C-POST. The trial included patients with cutaneous squamous cell carcinoma who were at high risk for recurrence. Results were presented at this year’s meeting of the American Society for Clinical Oncology (ASCO) held in Chicago.
After two years, 94.6% of cemiplimab-treated participants did not experience a recurrence of cutaneous squamous cell carcinoma, compared to 76.7% of participants in the placebo group who had no recurrence. Recurrence occurred in nine patients treated with the drug and 40 patients treated with placebo. Distant recurrence occurred in 10 patients treated with the drug and 26 patients treated with placebo.
In addition, 87.1% of cemiplimab-treated participants were still alive without the disease compared to 64.1% of placebo-treated participants. Four deaths were reported in the cemiplimab-treated group and eight in the placebo group from disease progression.
Overall, cemiplimab appeared safe in patients. The drug was discontinued in 9.8% of patients due to adverse events and 1.5% of patients on the placebo. Common adverse events included diarrhea, fatigue, itching, and rash.
Additional data confirming the results was published on May 31, 2025, in the New England Journal of Medicine to correspond with the meeting presentation. This data is from the primary analysis, which was conducted after half of the disease-free survival events had occurred (to allow for statistical calculation and analysis of the data).
The FDA currently approves cemiplimab for patients with advanced non-small cell lung cancer, basal cell carcinoma, and cutaneous squamous cell carcinoma that is metastatic (meaning the spread of the cancer cells from the primary tumor in the skin to other parts of the body) or locally advanced (meaning the cancer has grown significantly or penetrated deep into underlying tissues, muscles, or nerves) and are not eligible for surgery or radiation. The C-POST trial examined a group without current approval – those patients with cutaneous squamous cell carcinoma without an approved therapy who have a high risk for recurrence after surgery and radiation.
Cemiplimab is an immunotherapy drug that binds to the PD-1 receptor. It is designed to prevent the immune system from shutting down when it detects skin cancer.
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