Cemiplimab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Human |
| Target | PD-1 |
| Clinical data | |
| Pronunciation | sem' ip li" mab |
| Trade names | Libtayo |
| Other names | REGN-2810, REGN2810, cemiplimab-rwlc |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a618054 |
| License data |
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| Pregnancy category |
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| Routes of administration | Intravenous |
| ATC code | |
| Legal status | |
| Legal status | |
| Pharmacokinetic data | |
| Elimination half-life | 19 days |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
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| KEGG | |
| Chemical and physical data | |
| Formula | C6380H9808N1688O2000S44 |
| Molar mass | 143569.10 g·mol−1 |
Cemiplimab, sold under the brand name Libtayo, is a monoclonal antibody medication used for the treatment of squamous cell skin cancer.[7][8] Cemiplimab belongs to a class of drugs that binds to the programmed death receptor-1 (PD-1), blocking the PD-1/PD-L1 pathway.[6][9]
The most common side effects include fatigue, rash, diarrhea, musculoskeletal pain, and nausea.[7][6]
It was approved for medical use in the United States in September 2018,[7] in the European Union in June 2019.[8] and in Australia in July 2020.[1]
Cemiplimab is the first approval by the US Food and Drug Administration of a medication specifically for advanced cutaneous squamous cell carcinoma.[7] Cemiplimab is a therapeutic alternative on the World Health Organization's List of Essential Medicines.[10]
Medical uses
[edit]Cemiplimab is indicated for the treatment of cutaneous squamous cell carcinoma;[6][8] basal cell carcinoma;[6][8] non-small cell lung cancer;[6][8] and cervical cancer.[8]
Adverse effects
[edit]The US prescribing information includes warnings and precautions for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity.[11]
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.[8] 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).[8]
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.[8]
Cemiplimab can cause harm to a developing fetus; women should be advised of the potential risk to the fetus and to use effective contraception.[7]
Mechanism of action
[edit]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.[7][12]
History
[edit]The safety and efficacy of cemiplimab was studied in two open label clinical trials.[7] A total of 108 participants (75 with metastatic disease and 33 with locally advanced disease) were included in the efficacy evaluation.[7] 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.[7] Results showed that 47.2 percent of all participants treated with cemiplimab had their tumors shrink or disappear.[7] The majority of these participants had ongoing responses at the time of data analysis.[7]
The US Food and Drug Administration (FDA) granted the application of cemiplimab breakthrough therapy and priority review designations.[7] The FDA granted the approval of cemiplimab-rwlc to Regeneron Pharmaceuticals, Inc.[7]
In November 2022, the FDA approved cemiplimab in combination with platinum-based chemotherapy for adults with advanced non-small cell lung cancer with no EGFR, ALK, or ROS1 aberrations.[13]
In October 2025, the indication for cemiplimab was expanded to include the adjuvant treatment of adults with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation.[11] The efficacy was evaluated in C-POST (NCT03969004), a randomized, double-blind, multi-center, placebo-controlled trial in 415 participants with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation.[11] Participants were required to complete adjuvant radiation therapy within two to ten weeks of randomization.[11] The study excluded participants with autoimmune disease requiring systemic immunosuppressant agents within five years, a history of solid organ transplant, prior allogeneic or autologous stem cell transplantation, uncontrolled HIV, hepatitis B or hepatitis C infection, or an Eastern Oncology Group performance status ≥ 2.[11] Participants were randomized (1:1) to receive cemiplimab-rwlc or placebo.[11]
References
[edit]- ^ a b "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.
- ^ "AusPAR: Cemiplimab" (PDF). Therapeutic Goods Administration (TGA). 9 November 2020. Archived from the original (PDF) on 7 June 2021. Retrieved 6 June 2021.
- ^ "TGA eBS - Product and Consumer Medicine Information Licence".
- ^ "Cemiplimab Product information". Health Canada. 25 April 2012. Retrieved 29 May 2022.
- ^ "Summary Basis of Decision (SBD) for Libtayo". Health Canada. 23 October 2014. Retrieved 29 May 2022.
- ^ a b c d e f "Libtayo- cemiplimab-rwlc injection". DailyMed. 25 June 2020. Retrieved 16 August 2020.
- ^ a b c d e f g h i j k l m n "FDA approves first treatment for advanced form of the second most common skin cancer". U.S. Food and Drug Administration (FDA). 28 September 2018. Archived from the original on 15 December 2019. Retrieved 7 August 2020.
This article incorporates text from this source, which is in the public domain.
- ^ a b c d e f g h i j "Libtayo EPAR". European Medicines Agency (EMA). 24 April 2019. Retrieved 7 August 2020. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ Lee A, Duggan S, Deeks ED (June 2020). "Cemiplimab: A Review in Advanced Cutaneous Squamous Cell Carcinoma". Drugs. 80 (8): 813–819. doi:10.1007/s40265-020-01302-2. PMID 32306208. S2CID 215804809.
- ^ World Health Organization (2025). The selection and use of essential medicines, 2025: WHO Model List of Essential Medicines, 24th list. Geneva: World Health Organization. doi:10.2471/B09474. hdl:10665/382243.
- ^ a b c d e f "FDA approves cemiplimab-rwlc". U.S. Food and Drug Administration (FDA). 8 October 2025. Retrieved 10 October 2025. This article incorporates text from this source, which is in the public domain.
- ^ New PD-1 Inhibitor OK'd for Cutaneous SCC - Sixth PD-1/PD-L1 checkpoint inhibitor approved by agency 2018
- ^ "FDA approves cemiplimab-rwlc in combination with platinum-based chemotherapy for non-small cell lung cancer". U.S. Food and Drug Administration (FDA). 8 November 2022. Retrieved 20 December 2022. This article incorporates text from this source, which is in the public domain.
External links
[edit]- Clinical trial number NCT02383212 for "Study of REGN2810 (Anti-PD-1) in Patients With Advanced Malignancies" at ClinicalTrials.gov
- Clinical trial number NCT02760498 for "Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma" at ClinicalTrials.gov
- Clinical trial number NCT03132636 for "PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy" at ClinicalTrials.gov
- Clinical trial number NCT03409614 for "Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer" at ClinicalTrials.gov
- Clinical trial number NCT03088540 for "Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)" at ClinicalTrials.gov
- Clinical trial number NCT03969004 for "Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma" at ClinicalTrials.gov
