Cemiplimab

Binding of the PD-1 ligands PD-L1 and PD-L2 to the PD-1 receptor found on T cells inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors.

• LIBTAYO is a programmed death receptor-1 (PD-1) blocking antibody indicated: Cutaneous Squamous Cell Carcinoma (CSCC) for the treatment of adult patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. ( 1.1 ) for the adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation.

• None. None.contraindicated

Administer LIBTAYO as an intravenous infusion over 30 minutes after dilution. ( 2.2 ) Metastatic and locally advanced CSCC and BCC: 350 mg every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months. ( 2.2 ) Adjuvant treatment of CSCC at high risk of recurrence after surgery and radiation: 350 mg every 3 weeks for 12 weeks followed by 700 mg every 6 weeks until disease recurrence, unacceptable toxicity, or up to 48 weeks of total therapy, or 350 mg every 3 weeks until disease recurrence, unacceptable toxicity, or up to 48 weeks of total therapy. ( 2.2 ) NSCLC: 350 mg every 3 weeks until disease progression or unacceptable toxicity. ( 2.2 ) 2.1 Patient Selection for NSCLC Select patients with locally advanced or metastatic NSCLC for treatment with LIBTAYO as a single agent based on PD-L1 expression on tumor cells [see Clinical Studies (14.3) ]. Information on FDA-approved tests for the detection of PD-L1 expression is available at: http://www.fda.gov/CompanionDiagnostics. 2.2 Recommended Dosage The recommended dosages of LIBTAYO are presented in Table 1. Refer to the Prescribing Information for the agents administered in combination with LIBTAYO for recommended dosing information, as appropriate.

Immune-Mediated Adverse Reactions ( 5.1 ) Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, immune-mediated nephritis and renal dysfunction, and solid organ transplant rejection. Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. Withhold or permanently discontinue LIBTAYO based on the severity of reaction. ( 2.3 ) Infusion-Related Reactions: Interrupt, slow the rate of infusion, or permanently discontinue based on severity of reaction. ( 2.3 , 5.2 ) Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT): Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody. ( 5.3 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception. ( 5.4 , 8.1 , 8.3 ) 5.1 Severe and Fatal Immune-Mediated Adverse Reactions LIBTAYO is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or PD-ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions.

The following serious adverse reactions are described elsewhere in the labeling. Severe and Fatal Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1) ] Infusion-Related Reactions [see Warnings and Precautions (5.2) ] Complications of Allogeneic HSCT [see Warnings and Precautions (5.3) ] Most common adverse reactions (≥15%): LIBTAYO as a single agent in mCSCC or laCSCC, m BCC or laBCC, and NSCLC with high PD-L1 expression : Fatigue, musculoskeletal pain, rash, diarrhea, and anemia. ( 6.1 ) LIBTAYO as a single agent in adjuvant CSCC at high risk of recurrence: Rash and pruritus. ( 6.1 ) LIBTAYO in combination with platinum-based chemotherapy in NSCLC: Alopecia, musculoskeletal pain, nausea, fatigue, peripheral neuropathy, and decreased appetite. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Regeneron at 1-877-542-8296 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described in Warnings and Precautions reflect exposure to LIBTAYO as a single agent in 1281 patients with advanced cancers in three open-label, single-arm, multicohort studies, and two open-label randomized multi-center studies.

Lactation: Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on its mechanism of action, LIBTAYO can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on the use of LIBTAYO in pregnant women. Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death (see Data ) . Human IgG4 immunoglobulins (IgG4) are known to cross the placenta; therefore, LIBTAYO has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Animal reproduction studies have not been conducted with LIBTAYO to evaluate its effect on reproduction and fetal development. A central function of the PD-1/PD-L1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to the fetus.

Metabolism

Cemiplimab-rwlc pharmacokinetics were observed at steady state in patients with various solid tumors and are presented as mean (% coefficient of variation) unless otherwise specified. The pharmacokinetics of cemiplimab-rwlc increase in a dose proportional manner over the dose range of 1 mg/kg to 10 mg/kg (0.2 to 2 times the highest recommended approved dose; assuming a 70 kg patient) administered intravenously every 2 weeks.

• Sep 28, 2018BLABLA761097Regeneron Pharmaceuticals

1. 1Death1477.8%
2. 2Disease Progression1437.6%
3. 3Off Label Use1015.4%
4. 4Fatigue854.5%
5. 5Rash764.0%
6. 6Dyspnoea583.1%
7. 7Pyrexia573.0%
8. 8Pruritus512.7%
9. 9Myocarditis472.5%
10. 10Asthenia462.4%
11. 11Drug Ineffective462.4%
12. 12Diarrhoea442.3%
13. 13Interstitial Lung Disease432.3%
14. 14Nausea422.2%
15. 15Pneumonia351.9%

The 10 most recently updated of 226 ClinicalTrials.gov registrations naming Cemiplimab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fianlimab or Other Novel Combinations in Patients With Colorectal Cancer With Minimal Residual Disease Following Definitive Surgery and Chemotherapy (EMPIRE)
  Recruiting · Phase 2 · Interventional · 79 enrolled · NSABP Foundation Inc
  NCT07058012updated 2026-06-12
• Testing the Combination of Anti-cancer Drugs Actimab-A and Cemiplimab (REGN2810) to Improve Outcomes for Patients With Recurrent Glioblastoma
  Not yet recruiting · Phase 1 · Interventional · 30 enrolled · National Cancer Institute (NCI)
  NCT07422363updated 2026-06-12
• Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasal Squamous Cell Carcinoma
  Recruiting · Phase 2 · Interventional · 108 enrolled · National Cancer Institute (NCI)
  NCT07281417updated 2026-06-12
• Testing the Addition of an Anti-Cancer Drug, Cabozantinib to the Immunotherapy Drug Cemiplimab (REGN2810), in Adolescents and Adults With Advanced Adrenocortical Cancer
  Recruiting · Phase 2 · Interventional · 48 enrolled · National Cancer Institute (NCI)
  NCT06900595updated 2026-06-11
• Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advanced Non-small Cell Lung Cancer With N3 Lymph Node Involvement
  Recruiting · Phase 2 · Interventional · 21 enrolled · Georgetown University
  NCT06449313updated 2026-06-10
• Intravenous Vesicular Stomatitis Virus in Patients With Peripheral T-cell Lymphoma
  Recruiting · Phase 1 · Interventional · 21 enrolled · Mayo Clinic
  NCT06508463updated 2026-06-10
• A Vaccine (VSV-hIFNβ-NIS) With or Without Cyclophosphamide and Combinations of Ipilimumab, Nivolumab, and Cemiplimab in Treating Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia or Lymphoma
  Recruiting · Phase 1 · Interventional · 99 enrolled · Mayo Clinic
  NCT03017820updated 2026-06-10
• Cemiplimab Plus Fianlimab for the Treatment of Locally Advanced Head and Neck Basal Cell Carcinoma Before Surgery
  Suspended · Phase 2 · Interventional · 70 enrolled · Thomas Jefferson University
  NCT05929664updated 2026-06-10
• A Trial To Find Out If Vidutolimod Together With Cemiplimab Is Safe And If It Works In Adult Participants With Advanced Cancer Or Metastatic Cancer
  Terminated · Phase 2 · Interventional · 77 enrolled · Regeneron Pharmaceuticals
  NCT04916002updated 2026-06-09
• Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma
  Recruiting · Phase 3 · Interventional · 369 enrolled · Regeneron Pharmaceuticals
  NCT06585410updated 2026-06-08

Frequently asked questions

How does Cemiplimab work?

Binding of the PD-1 ligands PD-L1 and PD-L2 to the PD-1 receptor found on T cells inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors.

What is Cemiplimab used for?

According to FDA labeling, Cemiplimab carries indications including: LIBTAYO is a programmed death receptor-1 (PD-1) blocking antibody indicated: Cutaneous Squamous Cell Carcinoma (CSCC) for the treatment of adult patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. ( 1.1 ) for the adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Cemiplimab?

Cemiplimab is classified as PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors, Programmed Death Receptor-1-directed Antibody Interactions, Increased Cellular Death, Increased Immunologic Activity.

What are the brand names for Cemiplimab?

Cemiplimab is marketed under brand names including Libtayo.

What are the contraindications for Cemiplimab?

Cemiplimab labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.