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Synonyms: cemiplimab-rwlc | Libtayo® | REGN-2810 | REGN2810 | SAR-439684 | SAR439684
cemiplimab is an approved drug (FDA (2018), EMA (2019))
Compound class: Antibody
Comment: Cemiplimab (REGN2810) is a fully human anti-PD-1 immuno-oncology biological therapeutic that was developed by Regeneron Pharmaceuticals [1-2]. This antibody was produced using Regeneron's genetically engineered VelocImmune® mice which have humanized immunoglobulin gene loci and produce human:mouse hybrid antibodies that can rapidly be converted to fully human antibodies .
Full peptide sequence and disulphide bond information is available from the IMGT/mAb-DB entry for this antibody.
Ligand Activity Visualisation Charts
These are box plot that provide a unique visualisation, summarising all the activity data for a ligand taken from ChEMBL and GtoPdb across multiple targets and species. Click on a plot to see the median, interquartile range, low and high data points. A value of zero indicates that no data are available. A separate chart is created for each target, and where possible the algorithm tries to merge ChEMBL and GtoPdb targets by matching them on name and UniProt accession, for each available species. However, please note that inconsistency in naming of targets may lead to data for the same target being reported across multiple charts.✖
|No information available.|
|Summary of Clinical Use|
|Preclinical in vitro and in vivo characterisation of the antibody were reported by Burova et al. in 2017 . Clinical trial results (from trials NCT02383212 and NCT02760498) published in 2018  showed that ~50% of patients with advanced cutaneous squamous-cell carcinoma responded to treatment, with durable responses in 82% of responders with metastatic disease. Cemiplimab (Libtayo®) was granted FDA marketing authorisation in September 2018, as a treatment for metastatic cutaneous squamous cell carcinoma (CSCC), or locally advanced CSCC that cannot be treated with surgery or radiotherapy. Cemiplimab was also evaluated for efficacy (either alone or in combination with other drug or radiation therapies) against several other types of solid tumours, including non-small cell lung cancer, prostate cancer and cervical cancer, and in lymphoma. Click here to link to ClinicalTrials.gov's full list of registered cemiplimab (REGN2810) trials.
In February 2021, the FDA expanded approval to include use as a first-line treatment for locally advanced NSCLC tumours that have high PD-L1 expression but are negative for EGFR, ALK or ROS1 aberrations.
|Mechanism Of Action and Pharmacodynamic Effects|
|Cemiplimab enhances human primary T cell responses in vitro and inhibits the growth of syngeneic tumours in vivo .|
|Clinical Trial ID||Title||Type||Source||Comment||References|
|NCT02383212||Study of REGN2810 (Anti-PD-1) in Patients With Advanced Malignancies||Phase 1 Interventional||Regeneron Pharmaceuticals|
|NCT02760498||Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma||Phase 2 Interventional||Regeneron Pharmaceuticals|
|NCT03088540||Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)||Phase 3 Interventional||Regeneron Pharmaceuticals||5|
For extended ADME data see the following: