cemiplimab   Click here for help

GtoPdb Ligand ID: 10090

Synonyms: cemiplimab-rwlc | Libtayo® | REGN-2810 | REGN2810 | SAR-439684 | SAR439684
Approved drug Immunopharmacology Ligand
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 [4].
Full peptide sequence and disulphide bond information is available from the IMGT/mAb-DB entry for this antibody.
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No information available.
Summary of Clinical Use Click here for help
Preclinical in vitro and in vivo characterisation of the antibody were reported by Burova et al. in 2017 [1]. Clinical trial results (from trials NCT02383212 and NCT02760498) published in 2018 [3] 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 Click here for help
Cemiplimab enhances human primary T cell responses in vitro and inhibits the growth of syngeneic tumours in vivo [1].
Clinical Trials
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
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