Cemiplimab is under clinical development by Regeneron Pharmaceuticals and currently in Phase II for Head And Neck Cancer Squamous Cell Carcinoma. According to GlobalData, Phase II drugs for Head And Neck Cancer Squamous Cell Carcinoma have a 28% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Cemiplimab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Cemiplimab overview

Cemiplimab (Libtayo) is an anti-neoplastic agent. It is formulated as concentrate solution for intravenous route of administration. Libtayo is indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation. Libtayo is indicated for the treatment of patients with locally advanced basal cell carcinoma (laBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate and in patients with metastatic basal cell carcinoma (mBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate. Libtayo is indicated for the first-line treatment of patients with non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) ≥ 50%] as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations, and is locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or metastatic.

Cemiplimab (REGN-2810) is under development for the treatment of merkel cell carcinoma (MCC), advanced/metastatic penile carcinoma, recurrent glioblastoma multiforme (GBM), hepatitis B, cutaneous squamous cell carcinoma, advanced solid tumors including metastatic pancreatic cancer, epithelial ovarian cancer, primary peritoneal, advanced or metastatic secondary angiosarcoma, metastatic adenocarcinoma of the pancreas, metastatic hepatocellular carcinoma, fallopian tube cancer, thyroid cancer, metastatic prostate cancer (as a first-line therapy), metastatic hormone-sensitive prostate cancer, metastatic non-squamous non-small cell lung cancer (NSCLC), relapsed or refractory multiple myeloma, newly diagnosed diffuse intrinsic pontine glioma in children, newly diagnosed or recurrent high-grade glioma in children, pediatric glioblastoma, advanced malignancies, newly diagnosed glioblastoma, melanoma, basal cell carcinoma, non-small cell lung cancer, cutaneous squamous cell carcinoma, relapsed or refractory natural killer cell lymphoma, T-cell lymphomas, metastatic castration-resistant prostate cancer, colorectal cancer, triple negative breast cancer and adenocarcinoma of the prostate, cervical cancer, oropharyngeal cancer, clear cell renal cell carcinoma and advanced hematologic malignancies including relapsed and refractory B-cell Hodgkin lymphoma, B-cell non-Hodgkin lymphoma, head and neck squamous cell carcinoma, breast cancer (adjuvant), oral cancer, nasopharyngeal cancer, hypopharyngeal cancer and acute lymphoblastic leukemia. It is administered intravenously and intralesionally. The drug candidate is a fully human hinge-stabilized IgG4P monoclonal antibody which acts by targeting the PD-1 receptor. It is developed based on VelocImmune platform technology.

It was also under development for the treatment of squamous non-small cell lung cancer.

Regeneron Pharmaceuticals overview

Regeneron Pharmaceuticals (Regeneron) is engaged in discovering, developing, manufacturing, and marketing medicines for the treatment of serious medical conditions. Its products are focused on helping patients suffering from cancer, allergic and inflammatory diseases, eye diseases, metabolic and cardiovascular diseases, infectious diseases, neuromuscular diseases, hematologic conditions, pain, and rare diseases. It develops products using its Trap and VelociSuite technology platforms, which include VelocImmune, VelociGene, VelociMouse, VelociMab, Veloci-Bi, VelociT, and other related technologies. The company operates manufacturing facilities in Rensselaer, New York, and Limerick, Ireland. It also collaborates with strategic partners to develop, manufacture, and commercialize its products. It sells its products to specialty pharmacies and distributors. The company operates in the US, the Netherlands, Bermuda, Ireland, Spain, India, Japan, and the UK. Regeneron is headquartered in Tarrytown, New York, the US.

For a complete picture of Cemiplimab’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.