Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 121 |
| INN | Cemiplimab |
| Status | Approved |
| Drug code(s) | REGN2810, SAR439684 |
| Brand name | Libtayo |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Transgenic mouse (VelocImmune) |
| Target(s) | PD-1 |
| Indications of clinical studies | Cervical cancer, Head and neck cancers, Non-small cell lung cancer, Plasma cell myeloma, Basal cell carcinoma, Advanced Cutaneous Squamous Cell Carcinoma, Lymphoma, solid tumors, melanoma, renal cancer |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | December 15, 2014 |
| Start of Phase 2 | March 15, 2016 |
| Start of Phase 3 | May 30, 2017 |
| Date BLA/NDA submitted to FDA | February 28, 2018 |
| Year of first approval (global) | 2018 |
| Date of first US approval | September 28, 2018 |
| INN, US product name | Cemiplimab, cemiplimab-rwlc |
| US or EU approved indications | 1) first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score =50%), as determined by an FDA-approved test; 2) advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate, with full approval granted for locally advanced disease and accelerated approval granted for metastatic disease; 3) treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. |
| Company | Regeneron Pharmaceuticals |
| Licensee/Partner | None |
| Comments about company or candidate | Approval in the EU announced on July 1 2019. April 2018: Regeneron and Sanofi announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for surgery. PDUFA date is October 28, 2018. Dec 2017: Sanofi and Regeneron announced rolling BLA in advanced cutaneous squamous cell carcinoma had been initiated; expected to be complete by end of March 2018. Phase 3 in cervical cancer started in Oct 2017, NCT03088540 Phase 3 study in NSCLC recruiting as of May 30, 2017. Potentially pivotal Phase 2 study (NCT02760498) for the treatment of advanced cutaneous squamous cell carcinoma initiated in the second quarter of 2016. REGN 2810 is also being studied in combination with REGN1979 in B-cell malignancies. IND filing announced in Jan 2015. Regeneron and Sanofi's fast track-designated REGN2810, or cemiplimab, for adult patients with metastatic and locally and unresectable advanced cutaneous squamous cell carcinoma was granted breakthrough therapy designation by the FDA. |
| Full address of company | Tarrytown, New York, United States North America United States of America https://www.regeneron.com/ |
Immune checkpoint target. S228P hinge mutation.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |