Preventing Disease Recurrence with Cemiplimab in Patients Undergone Surgical Resection for Cutaneous Squamous Cell Carcinoma
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Reviewed & Translated by Dat Tien Nguyen, B.A, ScM.
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Posted on September 19th, 2025
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Cutaneous squamous-cell carcinoma is one of the most common forms of skin cancer, and it can easily be managed with surgical resection. In cases of recurrent disease, radiotherapy can be used, but treatment failure can still occur in certain patients. A study was funded by Sanofi & Regeneron Pharmaceuticals with the aims to explore the usage of cemiplimab in treating cutaneous squamous cell carcinoma in patients with a high likelihood of relapse.
The phase 3 clinical trials included 415 participants who had undergone resection surgery to treat localized cutaneous squamous cell carcinoma. Additionally, radiotherapy at a dose of 50 Gy was administered to these patients. The study exclusively enrolled patients who had a high risk of disease recurrence: individuals with affected lymph nodes, showed signs of neural invasion, or had a T4 primary tumor (thickness > 4 mm). Tumor biopsy showed that around 20% of the participants have less than 1% of tumor cells expressing PD-L1
The patients were randomly assigned to be treated intravenously with either placebo or cemiplimab. The medication was given with a starting dose of 350 mg every three weeks, which is doubled to 700 mg after the 12 weeks. Cemiplimab is an antibody that can bind to PD-1 protein and blocks its interaction with PD-L1. This interferes with the immunosuppressive effect of the tumor, allowing tumor clearance by the immune system.
After the first 24 weeks of treatment, the researchers recorded that cemiplimab reduced the risk of disease recurrence by 68%. Further analysis found that cemiplimab was effective at reducing both locoregional and distant recurrence. Also, the medication has a similar effectiveness in patients with tumors that express PD-L1 at different levels. Around 10% of those treated with cemiplimab discontinued their treatment due to adverse events, with the frequency of hypothyroidism and maculopapular rash higher than those treated with placebo.
The phase 3 clinical trials included 415 participants who had undergone resection surgery to treat localized cutaneous squamous cell carcinoma. Additionally, radiotherapy at a dose of 50 Gy was administered to these patients. The study exclusively enrolled patients who had a high risk of disease recurrence: individuals with affected lymph nodes, showed signs of neural invasion, or had a T4 primary tumor (thickness > 4 mm). Tumor biopsy showed that around 20% of the participants have less than 1% of tumor cells expressing PD-L1
The patients were randomly assigned to be treated intravenously with either placebo or cemiplimab. The medication was given with a starting dose of 350 mg every three weeks, which is doubled to 700 mg after the 12 weeks. Cemiplimab is an antibody that can bind to PD-1 protein and blocks its interaction with PD-L1. This interferes with the immunosuppressive effect of the tumor, allowing tumor clearance by the immune system.
After the first 24 weeks of treatment, the researchers recorded that cemiplimab reduced the risk of disease recurrence by 68%. Further analysis found that cemiplimab was effective at reducing both locoregional and distant recurrence. Also, the medication has a similar effectiveness in patients with tumors that express PD-L1 at different levels. Around 10% of those treated with cemiplimab discontinued their treatment due to adverse events, with the frequency of hypothyroidism and maculopapular rash higher than those treated with placebo.