Cemiplimab

{{Short description|Pharmaceutical drug}} {{Use dmy dates|date=July 2024}} {{cs1 config|name-list-style=vanc|display-authors=6}} {{Infobox drug | type = mab | image = | width = | alt = | caption =

| mab_type = mab | source = u | target = PD-1

| pronounce = sem' ip li" mab | tradename = Libtayo | Drugs.com = {{Drugs.com|monograph|cemiplimab-rwlc}} | MedlinePlus = a618054 | DailyMedID = Cemiplimab | pregnancy_AU = D | pregnancy_AU_comment = <ref name="Libtayo APMDS">{{cite web | title=Libtayo Australian Prescription Medicine Decision Summary | website=Therapeutic Goods Administration (TGA) | date=29 July 2020 | url=https://www.tga.gov.au/apm-summary/libtayo | access-date=16 August 2020 | archive-date=13 August 2020 | archive-url=https://web.archive.org/web/20200813141527/https://www.tga.gov.au/apm-summary/libtayo }}</ref> | pregnancy_category= | routes_of_administration = Intravenous | class = | ATC_prefix = L01 | ATC_suffix = FF06 | biosimilars =

| legal_AU = S4 | legal_AU_comment = <ref>{{cite web | title=AusPAR: Cemiplimab | website=Therapeutic Goods Administration (TGA) | date=9 November 2020 | url=https://www.tga.gov.au/sites/default/files/auspar-cemiplimab-201102.pdf | access-date=6 June 2021 | archive-date=7 June 2021 | archive-url=https://web.archive.org/web/20210607033305/https://www.tga.gov.au/sites/default/files/auspar-cemiplimab-201102.pdf }}</ref><ref>{{Cite web|url=https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2020-PI-01957-1&d=202106071016933|title = TGA eBS - Product and Consumer Medicine Information Licence}}</ref> | legal_BR =  | legal_BR_comment = | legal_CA = Rx-only | legal_CA_comment = / Schedule D<ref>{{cite web | title=Cemiplimab Product information | website=Health Canada | date=25 April 2012 | url=https://health-products.canada.ca/dpd-bdpp/info.do?lang=en&code=97728 | access-date=29 May 2022}}</ref><ref>{{cite web | title=Summary Basis of Decision (SBD) for Libtayo | website=Health Canada | date=23 October 2014 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00443&lang=en | access-date=29 May 2022}}</ref> | legal_DE =  | legal_DE_comment = | legal_NZ =  | legal_NZ_comment = | legal_UK =  | legal_UK_comment = | legal_US = Rx-only | legal_US_comment = <ref name="Libtayo FDA label" /><ref name="FDA PR" /> | legal_EU = Rx-only | legal_EU_comment = <ref name="Libtayo EPAR" /> | legal_UN =  | legal_UN_comment = | legal_status = Rx-only

| C = 6380 | H = 9808 | N = 1688 | O = 2000 | S = 44 }}

'''Cemiplimab''', sold under the brand name '''Libtayo''', is a monoclonal antibody medication used for the treatment of squamous cell skin cancer.<ref name="FDA PR" /><ref name="Libtayo EPAR" /> Cemiplimab belongs to a class of drugs that binds to the programmed death receptor-1 (PD-1), blocking the PD-1/PD-L1 pathway.<ref name="Libtayo FDA label">{{cite web | title=Libtayo- cemiplimab-rwlc injection | website=DailyMed | date=25 June 2020 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4347ae1f-d397-4f18-8b70-03897e1c054a | access-date=16 August 2020}}</ref><ref name="pmid32306208">{{cite journal | vauthors = Lee A, Duggan S, Deeks ED | title = Cemiplimab: A Review in Advanced Cutaneous Squamous Cell Carcinoma | journal = Drugs | volume = 80 | issue = 8 | pages = 813–819 | date = June 2020 | pmid = 32306208 | doi = 10.1007/s40265-020-01302-2 | s2cid = 215804809 }}</ref>

The most common side effects include fatigue, rash, diarrhea, musculoskeletal pain, and nausea.<ref name="FDA PR" /><ref name="Libtayo FDA label" />

It was approved for medical use in the United States in September 2018,<ref name="FDA PR">{{cite web | title=FDA approves first treatment for advanced form of the second most common skin cancer | website=U.S. Food and Drug Administration (FDA) | date=28 September 2018 | url=https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-advanced-form-second-most-common-skin-cancer | archive-url=https://web.archive.org/web/20191215152539/https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-advanced-form-second-most-common-skin-cancer | archive-date=15 December 2019 | access-date=7 August 2020}} {{PD-notice}}</ref> in the European Union in June 2019.<ref name="Libtayo EPAR">{{cite web | title=Libtayo EPAR | website=European Medicines Agency (EMA) | date=24 April 2019 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/libtayo | access-date=7 August 2020}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> and in Australia in July 2020.<ref name="Libtayo APMDS" />

Cemiplimab is the first approval by the US Food and Drug Administration of a medication specifically for advanced cutaneous squamous cell carcinoma.<ref name="FDA PR" /> Cemiplimab is a therapeutic alternative on the World Health Organization's List of Essential Medicines.<ref name="WHO24th">{{cite book | title = The selection and use of essential medicines, 2025: WHO Model List of Essential Medicines, 24th list | year = 2025 | hdl = 10665/382243 | publisher = World Health Organization | location = Geneva | doi = 10.2471/B09474 | hdl-access=free }}</ref>

== Medical uses == Cemiplimab is indicated for the treatment of cutaneous squamous cell carcinoma;<ref name="Libtayo FDA label" /><ref name="Libtayo EPAR" /> basal cell carcinoma;<ref name="Libtayo FDA label" /><ref name="Libtayo EPAR" /> non-small cell lung cancer;<ref name="Libtayo FDA label" /><ref name="Libtayo EPAR" /> and cervical cancer.<ref name="Libtayo EPAR" />

== Adverse effects == 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.<ref name="FDA 20251008" />

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.<ref name="Libtayo EPAR" /> 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).<ref name="Libtayo EPAR" />

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.<ref name="Libtayo EPAR" />

Cemiplimab can cause harm to a developing fetus; women should be advised of the potential risk to the fetus and to use effective contraception.<ref name="FDA PR" />

==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.<ref name="FDA PR" /><ref>[https://www.medpagetoday.com/dermatology/skincancer/75405 ''New PD-1 Inhibitor OK'd for Cutaneous SCC - Sixth PD-1/PD-L1 checkpoint inhibitor approved by agency'' 2018]</ref>

== History == The safety and efficacy of cemiplimab was studied in two open label clinical trials.<ref name="FDA PR" /> A total of 108 participants (75 with metastatic disease and 33 with locally advanced disease) were included in the efficacy evaluation.<ref name="FDA PR" /> 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.<ref name="FDA PR" /> Results showed that 47.2 percent of all participants treated with cemiplimab had their tumors shrink or disappear.<ref name="FDA PR" /> The majority of these participants had ongoing responses at the time of data analysis.<ref name="FDA PR" />

The US Food and Drug Administration (FDA) granted the application of cemiplimab breakthrough therapy and priority review designations.<ref name="FDA PR" /> The FDA granted the approval of cemiplimab-rwlc to Regeneron Pharmaceuticals.<ref name="FDA PR" />

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.<ref>{{cite web | title=FDA approves cemiplimab-rwlc in combination with platinum-based chemotherapy for non-small cell lung cancer | website=U.S. Food and Drug Administration (FDA) | date=8 November 2022 | url=https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-combination-platinum-based-chemotherapy-non-small-cell-lung-cancer | access-date=20 December 2022}} {{PD-notice}}</ref>

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.<ref name="FDA 20251008">{{cite web | title=FDA approves cemiplimab-rwlc | website=U.S. Food and Drug Administration (FDA) | date=8 October 2025 | url=https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma | access-date=10 October 2025}} {{PD-notice}}</ref> 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.<ref name="FDA 20251008" /> Participants were required to complete adjuvant radiation therapy within two to ten weeks of randomization.<ref name="FDA 20251008" /> 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.<ref name="FDA 20251008" /> Participants were randomized (1:1) to receive cemiplimab-rwlc or placebo.<ref name="FDA 20251008" />

== References == {{reflist}}

== External links == * {{ClinicalTrialsGov|NCT02383212|Study of REGN2810 (Anti-PD-1) in Patients With Advanced Malignancies}} * {{ClinicalTrialsGov|NCT02760498|Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma}} * {{ClinicalTrialsGov|NCT03132636|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}} * {{ClinicalTrialsGov|NCT03409614|Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer}} * {{ClinicalTrialsGov|NCT03088540|Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)}} * {{ClinicalTrialsGov|NCT03969004|Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma}}

{{Targeted cancer therapeutic agents}} {{PD-1_and_PD-L1_inhibitors}} {{Monoclonals for tumors}} {{Monoclonals for immune system}} {{Portal bar | Medicine}} {{Authority control}}

Category:Antineoplastic drugs Category:Monoclonal antibodies for tumors Category:Sanofi Category:World Health Organization essential medicines