cemiplimab

Home
Ligands
cemiplimab

GtoPdb Ligand ID: 10090

cemiplimab is an approved drug (FDA (2018), EMA (2019))

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.

View interactive charts of activity data across species

No information available.

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 [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.

Summary of Clinical Use

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
Cemiplimab enhances human primary T cell responses in vitro and inhibits the growth of syngeneic tumours in vivo [1].

Mechanism Of Action and Pharmacodynamic Effects

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