Cemiplimab
Introduction to Cemiplimab
Cemiplimab (brand name: Libtayo) is a fully human monoclonal antibody targeting the programmed death receptor-1 (PD-1). It belongs to the class of immune checkpoint inhibitors and was developed by Regeneron Pharmaceuticals and Sanofi. Cemiplimab was first approved by the FDA in 2018 for the treatment of advanced cutaneous squamous cell carcinoma (CSCC).
Mechanism of Action
Cemiplimab works by binding to PD-1 receptors on T cells, blocking their interaction with PD-L1 and PD-L2 ligands. This blockade prevents the inhibition of T cell activation, thereby enhancing the immune system's ability to detect and destroy cancer cells. By targeting the PD-1/PD-L1 pathway, cemiplimab helps restore T cell-mediated anti-tumor immune responses.
Indications
- Advanced cutaneous squamous cell carcinoma (CSCC)
- Locally advanced or metastatic basal cell carcinoma (BCC) in patients previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate
- First-line treatment of advanced non-small cell lung cancer (NSCLC) with high PD-L1 expression
Note: Indications may vary by country and regulatory approval status.
Dosage and Administration
The recommended dosage for adults is 350 mg administered as an intravenous infusion over 30 minutes every 3 weeks. Treatment should continue until disease progression or unacceptable toxicity occurs. Dose modifications may be necessary based on adverse reactions.
Adverse Effects
Common adverse effects include:
- Fatigue
- Rash
- Diarrhea
- Nausea
- Musculoskeletal pain
- Anemia
Serious immune-mediated adverse reactions may occur, affecting various organ systems:
- Pneumonitis
- Colitis
- Hepatitis
- Endocrinopathies (e.g., thyroid disorders, adrenal insufficiency)
- Nephritis
- Dermatologic reactions
Precautions and Contraindications
- Monitor for signs and symptoms of immune-mediated adverse reactions
- Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment
- Contraindicated in patients with a history of severe hypersensitivity to cemiplimab or any of its components
- Use with caution in patients with a history of autoimmune disorders
- Avoid use of systemic corticosteroids or immunosuppressants before starting cemiplimab, unless indicated for physiological reasons
Pediatric Considerations
The safety and efficacy of cemiplimab in pediatric patients have not been established. Clinical trials have primarily focused on adult populations. However, research is ongoing to evaluate its potential use in pediatric cancers, particularly in advanced solid tumors and lymphomas that have failed standard therapies.
Pediatricians should be aware of the following:
- Off-label use may be considered in refractory cases of advanced pediatric cancers, but should be done with caution and in specialized centers
- Dosing in pediatric patients, if used, is typically based on body weight or body surface area
- The spectrum of immune-related adverse events in children may differ from adults and requires close monitoring
- Long-term effects on the developing immune system are not yet fully understood
