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Cemiplimab: Uses, Mechanism & Side Effects

Cemiplimab is a monoclonal antibody used to treat certain skin cancers and non-small cell lung cancer. It belongs to the class of immune checkpoint inhibitors targeting PD-1.

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Things worth knowing about "Cemiplimab"

Cemiplimab is a monoclonal antibody used to treat certain skin cancers and non-small cell lung cancer. It belongs to the class of immune checkpoint inhibitors targeting PD-1.

What is Cemiplimab?

Cemiplimab (brand name: Libtayo) is a monoclonal antibody belonging to the class of immune checkpoint inhibitors. It was developed by Regeneron and Sanofi and has been approved by both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). Cemiplimab is administered intravenously and works by targeting the programmed cell death receptor 1 (PD-1), helping the immune system to recognize and destroy cancer cells more effectively.

Indications (Approved Uses)

Cemiplimab is approved for the following conditions:

Cutaneous squamous cell carcinoma (cSCC): Treatment of adults with metastatic or locally advanced cSCC who are not candidates for curative surgery or radiation.
Basal cell carcinoma (BCC): Treatment of adults with locally advanced or metastatic BCC that has progressed on or is intolerant to hedgehog pathway inhibitor therapy.
Non-small cell lung cancer (NSCLC): As first-line therapy in adults with advanced NSCLC without certain mutations (EGFR, ALK) and with high PD-L1 expression, as monotherapy or in combination with chemotherapy.
Cervical cancer: In combination with chemotherapy (with or without bevacizumab) for recurrent or metastatic cervical cancer.

Mechanism of Action

Cemiplimab works by blocking the PD-1 receptor on the surface of T-cells (a type of white blood cell). Under normal circumstances, the ligands PD-L1 and PD-L2 bind to this receptor and suppress the immune response, preventing the immune system from attacking the body's own tissue. Cancer cells exploit this mechanism to evade immune detection by expressing high levels of PD-L1 on their surface.

By blocking the PD-1 receptor, cemiplimab removes this so-called immune checkpoint inhibition. This allows T-cells to recognize and destroy cancer cells once again. This process is referred to as immune checkpoint blockade.

Dosage and Administration

Cemiplimab is administered as an intravenous (IV) infusion at a hospital or specialized treatment center. The standard dosage is:

350 mg every 3 weeks as an IV infusion over 30 minutes, or
350 mg every 3 weeks (a 6-week dosing schedule may be used for certain indications)

The exact dosage and treatment schedule are determined individually by the treating physician based on the underlying condition and the overall health status of the patient.

Side Effects

Like all immune checkpoint inhibitors, cemiplimab can cause immune-related adverse events (irAEs), as the broadly activated immune system may attack healthy tissue. Common and serious side effects include:

Common Side Effects

Fatigue and exhaustion
Skin rash and itching
Diarrhea
Muscle and joint pain
Changes in liver enzyme levels
Loss of appetite

Serious Immune-Related Side Effects

Pneumonitis (immune-related lung inflammation)
Colitis (inflammation of the intestinal lining)
Hepatitis (liver inflammation)
Endocrinopathies (e.g., thyroiditis, adrenal insufficiency, hypophysitis)
Nephritis (kidney inflammation)
Myocarditis (heart muscle inflammation)
Severe skin reactions (e.g., Stevens-Johnson syndrome)

If serious immune-related reactions occur, temporary suspension or permanent discontinuation of therapy may be necessary, along with the administration of corticosteroids.

Contraindications and Special Precautions

Cemiplimab should not be used in patients with known hypersensitivity to the active substance.
Use during pregnancy is contraindicated, as it may cause harm to the unborn child. Women of childbearing potential should use reliable contraception during treatment and for at least 4 months after the last dose.
Patients with autoimmune diseases should carefully discuss the risks and benefits of therapy with their physician.
Regular blood tests to monitor liver, kidney, and thyroid function are required during treatment.

References

European Medicines Agency (EMA): Libtayo (Cemiplimab) - Product Information and Assessment Report. Available at: www.ema.europa.eu
Migden MR et al. - PD-1 Blockade with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma. New England Journal of Medicine, 2018; 379:341-351.
Regeneron Pharmaceuticals / Sanofi: Libtayo Summary of Product Characteristics (SmPC), most recent version.

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