Cemiplimab

Cemiplimab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetPD-1
Names
Pronunciationsem' ip li" mab
Trade namesLibtayo
Other namesREGN-2810, REGN2810, cemiplimab-rwlc
Clinical data
Main usesSquamous cell skin cancer, basal cell cancer, non-small cell lung cancer (NSCLC)[1][2]
Side effectsLow thyroid, pneumonitis, skin reactions, high thyroid, inflammation of the liver[1]
WHO AWaReUnlinkedWikibase error: ⧼unlinkedwikibase-error-statements-entity-not-set⧽
Pregnancy
category
  • AU: D[3]
  • US: N (Not classified yet)
    Routes of
    use    		Intravenous infusion
    Typical dose350 mg q 3 weeks[1]
    External links
    AHFS/Drugs.comMonograph
    MedlinePlusa618054
    Legal
    License data
    Legal status
    Pharmacokinetics
    Elimination half-life19 days
    Chemical and physical data
    FormulaC6380H9808N1688O2000S44
    Molar mass143569.10 g·mol−1

    Cemiplimab, sold under the brand name Libtayo, is a medication used to treat squamous cell skin cancer, basal cell cancer, and certain non-small cell lung cancer (NSCLC).[1][2] It is used for advanced cases that cannot be cured by surgery.[1] It is given by injection into a vein.[1]

    Common side effects include low thyroid with tiredness and weight gain; pneumonitis with shortness of breath and cough; skin reactions; high thyroid with sweating and weight; and inflammation of the liver.[1] Other side effects may include infusion reactions and muscle pain.[2] Use during pregnancy may harm the baby.[2] It is a monoclonal antibody that binds to programmed death receptor-1 (PD-1), allowing T cells to kill cancer cells.[1]

    Cemiplimab was approved for medical use in the United States in 2018 and Europe in 2019.[6][1] It was approved for medical use in Australia in July 2020.[3] In the United Kingdom it costs the NHS £4,650 every 3 weeks.[7] This amount in the United States costs about $9,800.[8]

    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.[6][1]

    Dosage

    It is given at a dose of 350 mg once every 3 weeks.[1]

    Side 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.[1] 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).[1]

    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.[1]

    Cemiplimab can cause harm to a developing fetus; women should be advised of the potential risk to the fetus and to use effective contraception.[6]

    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.[6][9]

    History

    The safety and efficacy of cemiplimab was studied in two open label clinical trials.[6] A total of 108 participants (75 with metastatic disease and 33 with locally-advanced disease) were included in the efficacy evaluation.[6] 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.[6] Results showed that 47.2 percent of all participants treated with cemiplimab had their tumors shrink or disappear.[6] The majority of these participants had ongoing responses at the time of data analysis.[6]

    The U.S. Food and Drug Administration (FDA) granted the application of cemiplimab breakthrough therapy and priority review designations.[6] The FDA granted the approval of cemiplimab-rwlc to Regeneron Pharmaceuticals, Inc.[6]

    Cemiplimab is the first FDA approval of a medication specifically for advanced cutaneous squamous cell carcinoma (CSCC).[6]

    Research

    As of 2017, cemiplimab is being investigated for the treatment of myeloma.[10][11]

    As of 2018, cemiplimab is being investigated for the treatment of lung cancer.[12][13]

    As of 2021, cemiplimab is in Phase 3 clinical trials for advanced cervical cancer.[14]

    References

    1. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 "Libtayo EPAR". European Medicines Agency (EMA). 24 April 2019. Archived from the original on 23 June 2020. Retrieved 7 August 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
    2. 1 2 3 4 5 "Libtayo- cemiplimab-rwlc injection". DailyMed. 25 June 2020. Archived from the original on 17 October 2020. Retrieved 16 August 2020.
    3. 1 2 "Libtayo Australian Prescription Medicine Decision Summary". Therapeutic Goods Administration (TGA). 29 July 2020. Archived from the original on 13 August 2020. Retrieved 16 August 2020.
    4. ↑ "AusPAR: Cemiplimab" (PDF). Therapeutic Goods Administration (TGA). 9 November 2020. Archived (PDF) from the original on 7 June 2021. Retrieved 6 June 2021.
    5. ↑ "TGA eBS - Product and Consumer Medicine Information Licence". Archived from the original on 2021-06-07. Retrieved 2021-06-13.
    6. 1 2 3 4 5 6 7 8 9 10 11 12 13 "FDA approves first treatment for advanced form of the second most common skin cancer". U.S. Food and Drug Administration. 28 September 2018. Archived from the original on 8 August 2020. Retrieved 7 August 2020. Public Domain This article incorporates text from this source, which is in the public domain.
    7. ↑ BNF 81: March-September 2021. BMJ Group and the Pharmaceutical Press. 2021. p. 912. ISBN 978-0857114105.
    8. ↑ "Libtayo Prices, Coupons & Patient Assistance Programs". Drugs.com. Archived from the original on 22 January 2021. Retrieved 2 January 2022.
    9. ↑ "New PD-1 Inhibitor OK'd for Cutaneous SCC - Sixth PD-1/PD-L1 checkpoint inhibitor approved by agency 2018". Archived from the original on 2021-03-04. Retrieved 2021-06-13.
    10. ↑ "Isatuximab in Combination With Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients". ClinicalTrials.gov. 21 June 2017. Archived from the original on 15 June 2020. Retrieved 7 August 2020.
    11. ↑ "History of Changes for Study: NCT03194867". ClinicalTrials.gov. 2 June 2020. Archived from the original on 1 November 2021. Retrieved 7 August 2020.
    12. ↑ "A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer". ClinicalTrials.gov. 12 February 2018. Archived from the original on 15 June 2020. Retrieved 7 August 2020.
    13. ↑ "History of Changes for Study: NCT03430063". ClinicalTrials.gov. 13 April 2020. Archived from the original on 1 November 2021. Retrieved 7 August 2020.
    14. ↑ Sanofi and Regeneron Halt Cervical Cancer Trial Early Due to Dazzling Results, Plan to Submit to Regulators Archived 2021-05-03 at the Wayback Machine Biospace Mar 15, 2021
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