Cemiplimab, sold under the brand name Libtayo, is a

monoclonal antibody A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a cell lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell. Monoclonal antibodie ...

medication for the treatment of squamous cell skin cancer. Cemiplimab belongs to a class of drugs that binds to the programmed death receptor-1 (PD-1), blocking the PD-1/PD-L1 pathway. The most common side effects include fatigue, rash, diarrhea, musculoskeletal pain, and nausea. In September 2018, it was approved by the US

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

(FDA) for treating people with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. It was approved for medical use in the European Union in June 2019. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. It was approved for medical use in Australia in July 2020. Cemiplimab is the first FDA approval of a medication specifically for advanced cutaneous squamous cell carcinoma (CSCC).

Medical uses

Cemiplimab is indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

Adverse effects

Cemiplimab is associated with side effects related to the activity of the immune system, which can be serious, although most side effects go away with appropriate treatment or on stopping cemiplimab. The most common immune-related effects (which may affect up to 1 in 10 people) were

hypothyroidism Hypothyroidism is an endocrine disease in which the thyroid gland does not produce enough thyroid hormones. It can cause a number of symptoms, such as cold intolerance, poor ability to tolerate cold, fatigue, extreme fatigue, muscle aches, co ...

(an underactive

thyroid gland The thyroid, or thyroid gland, is an endocrine gland in vertebrates. In humans, it is a butterfly-shaped gland located in the neck below the Adam's apple. It consists of two connected lobes. The lower two thirds of the lobes are connected by ...

with tiredness, weight gain, and skin and hair changes),

pneumonitis Pneumonitis describes general inflammation of lung tissue. Possible causative agents include radiation therapy of the chest, exposure to medications used during chemo-therapy, the inhalation of debris (e.g., animal dander), aspiration, herbicide ...

(inflammation in the lungs causing shortness of breath and cough), skin reactions,

hyperthyroidism Hyperthyroidism is a endocrine disease in which the thyroid gland produces excessive amounts of thyroid hormones. Thyrotoxicosis is a condition that occurs due to elevated levels of thyroid hormones of any cause and therefore includes hyperth ...

(an overactive thyroid gland which can cause hyperactivity, sweating, weight loss and thirst) and

hepatitis Hepatitis is inflammation of the liver parenchyma, liver tissue. Some people or animals with hepatitis have no symptoms, whereas others develop yellow discoloration of the skin and whites of the eyes (jaundice), Anorexia (symptom), poor appetite ...

(inflammation of the liver). Severe reactions, including

Stevens–Johnson syndrome Stevens–Johnson syndrome (SJS) is a type of severe skin reaction. Together with toxic epidermal necrolysis (TEN) and #Classification, Stevens–Johnson/toxic epidermal necrolysis (SJS/TEN) overlap, they are considered febrile mucocutaneous d ...

and

toxic epidermal necrolysis Toxic epidermal necrolysis (TEN), also known as Lyell's syndrome, is a type of severe skin reaction. Together with Stevens–Johnson syndrome (SJS) it forms a spectrum of disease, with TEN being more severe. Early symptoms include fever and f ...

(life-threatening reactions with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals) have been reported with cemiplimab. Cemiplimab can cause harm to a developing fetus; women should be advised of the potential risk to the fetus and to use effective contraception.

Mechanism of action

Cemiplimab targets the cellular pathway known as

PD-1 Programmed cell death protein 1 (PD-1), (CD279 cluster of differentiation 279). PD-1 is a protein encoded in humans by the ''PDCD1'' gene. PD-1 is a cell surface receptor on T cells and B cells that has a role in regulating the immune system's re ...

(protein found on the body's immune cells and some cancer cells) so it acts as a

checkpoint inhibitor Checkpoint inhibitor therapy is a form of Treatment of cancer, cancer immunotherapy. The therapy targets immune checkpoints, key regulators of the immune system that when stimulated can dampen the immune response to an immunologic stimulus. Some ca ...

History

The safety and efficacy of cemiplimab was studied in two open label clinical trials. A total of 108 participants (75 with metastatic disease and 33 with locally advanced disease) were included in the efficacy evaluation. The study's primary endpoint was objective response rate, or the percentage of participants who experienced partial shrinkage or complete disappearance of their tumor(s) after treatment. Results showed that 47.2 percent of all participants treated with cemiplimab had their tumors shrink or disappear. The majority of these participants had ongoing responses at the time of data analysis. The US

(FDA) granted the application of cemiplimab breakthrough therapy and

priority review Priority review is a program of the United States Food and Drug Administration (FDA) to expedite the review process for drugs that are expected to have a particularly great impact on the treatment of a disease. The priority review voucher program ...

designations. The FDA granted the approval of cemiplimab-rwlc to Regeneron Pharmaceuticals, Inc. In November 2022, the FDA approved cemiplimab in combination with platinum-based chemotherapy for adults with advanced non-small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations.

Research

, cemiplimab is being investigated for the treatment of

myeloma Multiple myeloma (MM), also known as plasma cell myeloma and simply myeloma, is a cancer of plasma cells, a type of white blood cell that normally produces antibodies. Often, no symptoms are noticed initially. As it progresses, bone pain, a ...

. , cemiplimab is being investigated for the treatment of

lung cancer Lung cancer, also known as lung carcinoma, is a malignant tumor that begins in the lung. Lung cancer is caused by genetic damage to the DNA of cells in the airways, often caused by cigarette smoking or inhaling damaging chemicals. Damaged ...

. , cemiplimab is in phase III clinical trials for advanced

cervical cancer Cervical cancer is a cancer arising from the cervix or in any layer of the wall of the cervix. It is due to the abnormal growth of cells that can invade or spread to other parts of the body. Early on, typically no symptoms are seen. Later sympt ...

. Based on findings from the Phase
EMPOWER-Cervical 1 trial (NCT03257267)
the

European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products ...

’s

Committee for Medicinal Products for Human Use The Committee for Medicinal Products for Human Use (CHMP), formerly known as the Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regar ...

has adopted a positive opinion for Libtayo monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after platinum-based chemotherapy. As of 2022, cemiplimab is in phase II clinical trials for treatment of cutaneous

squamous cell carcinoma Squamous-cell carcinoma (SCC), also known as epidermoid carcinoma, comprises a number of different types of cancer that begin in squamous cells. These cells form on the surface of the skin, on the lining of hollow organs in the body, and on the ...

References

{{Portal bar , Medicine Monoclonal antibodies for tumors Sanofi