Cemiplimab

Cemiplimab, sold under the brand name Libtayo, is a monoclonal antibody medication for the treatment of squamous cell skin cancer.[2][3] Cemiplimab belongs to a class of drugs that binds to the programmed death receptor-1 (PD-1), blocking the PD-1/PD-L1 pathway.[4]

Cemiplimab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetPD-1
Clinical data
Trade namesLibtayo
Other namesREGN-2810, REGN2810, cemiplimab-rwlc
AHFS/Drugs.comMonograph
MedlinePlusa618054
License data
Pregnancy
category
  • AU: D [1]
  • US: N (Not classified yet)
    Routes of
    administration    		Intravenous infusion
    ATC code
    Legal status
    Legal status
    • AU: S4 (Prescription only)
    • US: ℞-only [2]
    • EU: Rx-only [3]
    • In general: ℞ (Prescription only)
    Pharmacokinetic data
    Elimination half-life19 days
    Identifiers
    CAS Number
    DrugBank
    ChemSpider
    • none
    UNII
    KEGG
    Chemical and physical data
    FormulaC6380H9808N1688O2000S44
    Molar mass143569.10 g·mol−1

    The most common side effects include fatigue, rash, diarrhea, musculoskeletal pain, and nausea.[2][4]

    In September 2018, it was approved by the U.S. Food and Drug Administration (FDA) for treating people with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.[2] It was approved for medical use in the European Union in June 2019.[3] It was approved for medical use in Australia in July 2020.[1]

    Cemiplimab is the first FDA approval of a medication specifically for advanced cutaneous squamous cell carcinoma (CSCC).[2]

    Medical uses

    Cemiplimab is indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.[2][3]

    Adverse effects

    Cemiplimab is associated with side effects related to the activity of the immune system, which can be serious, although most side effects go away with appropriate treatment or on stopping cemiplimab.[3] The most common immune-related effects (which may affect up to 1 in 10 people) were hypothyroidism (an underactive thyroid gland with tiredness, weight gain, and skin and hair changes), pneumonitis (inflammation in the lungs causing shortness of breath and cough), skin reactions, hyperthyroidism (an overactive thyroid gland which can cause hyperactivity, sweating, weight loss and thirst) and hepatitis (inflammation of the liver).[3]

    Severe reactions, including Stevens–Johnson syndrome and toxic epidermal necrolysis (life-threatening reactions with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals) have been reported with cemiplimab.[3]

    Cemiplimab can cause harm to a developing fetus; women should be advised of the potential risk to the fetus and to use effective contraception.[2]

    Mechanism of action

    Cemiplimab targets the cellular pathway known as PD-1 (protein found on the body’s immune cells and some cancer cells) so it acts as a checkpoint inhibitor.[2][5]

    History

    The safety and efficacy of cemiplimab was studied in two open label clinical trials.[2] A total of 108 participants (75 with metastatic disease and 33 with locally-advanced disease) were included in the efficacy evaluation.[2] The study’s primary endpoint was objective response rate, or the percentage of participants who experienced partial shrinkage or complete disappearance of their tumor(s) after treatment.[2] Results showed that 47.2 percent of all participants treated with cemiplimab had their tumors shrink or disappear.[2] The majority of these participants had ongoing responses at the time of data analysis.[2]

    The U.S. Food and Drug Administration (FDA) granted the application of cemiplimab breakthrough therapy and priority review designations.[2] The FDA granted the approval of cemiplimab-rwlc to Regeneron Pharmaceuticals, Inc.[2]

    Research

    As of 2017, cemiplimab is being investigated for the treatment of myeloma.[6][7]

    As of 2018, cemiplimab is being investigated for the treatment of lung cancer.[8][9]

    References
    1. "Libtayo Australian Prescription Medicine Decision Summary". Therapeutic Goods Administration (TGA). 29 July 2020. Retrieved 16 August 2020.
    2. "FDA approves first treatment for advanced form of the second most common skin cancer". U.S. Food and Drug Administration. 28 September 2018. Retrieved 7 August 2020. This article incorporates text from this source, which is in the public domain.
    3. "Libtayo EPAR". European Medicines Agency (EMA). 24 April 2019. Retrieved 7 August 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
    4. "Libtayo- cemiplimab-rwlc injection". DailyMed. 25 June 2020. Retrieved 16 August 2020.
    5. New PD-1 Inhibitor OK'd for Cutaneous SCC - Sixth PD-1/PD-L1 checkpoint inhibitor approved by agency 2018
    6. "Isatuximab in Combination With Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients". ClinicalTrials.gov. 21 June 2017. Retrieved 7 August 2020.
    7. "History of Changes for Study: NCT03194867". ClinicalTrials.gov. 2 June 2020. Retrieved 7 August 2020.
    8. "A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer". ClinicalTrials.gov. 12 February 2018. Retrieved 7 August 2020.
    9. "History of Changes for Study: NCT03430063". ClinicalTrials.gov. 13 April 2020. Retrieved 7 August 2020.
    • "Cemiplimab". Drug Information Portal. U.S. National Library of Medicine.
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