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Cemiplimab, sold under the brand name Libtayo, is a monoclonal antibody 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 (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. 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 (an underactive thyroid gland with tiredness, weight gain, and skin and hair changes), pneumonitis (inflammation in the lungs causing shortness of breath and cough), skin reactions, hyperthyroidism (an overactive thyroid gland which can cause hyperactivity, sweating, weight loss and thirst) and hepatitis (inflammation of the liver).

Severe reactions, including Stevens–Johnson syndrome and toxic epidermal necrolysis (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 (protein found on the body's immune cells and some cancer cells) so it acts as a checkpoint inhibitor.

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 Food and Drug Administration (FDA) granted the application of cemiplimab breakthrough therapy and priority review 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

As of 2017, cemiplimab is being investigated for the treatment of myeloma.

As of 2018, cemiplimab is being investigated for the treatment of lung cancer.

As of 2021, cemiplimab is in phase III clinical trials for advanced cervical cancer. Based on findings from the Phase 3 EMPOWER-Cervical 1 trial (NCT03257267), the European Medicines Agency’s Committee for Medicinal Products for Human Use 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.

References

1. ^ "Libtayo Australian Prescription Medicine Decision Summary". Therapeutic Goods Administration (TGA). 29 July 2020. Archived from the original on 13 August 2020. Retrieved 16 August 2020.
2. "AusPAR: Cemiplimab" (PDF). Therapeutic Goods Administration (TGA). 9 November 2020. Archived from the original (PDF) on 7 June 2021. Retrieved 6 June 2021.
3. "TGA eBS - Product and Consumer Medicine Information Licence".
4. "Cemiplimab Product information". Health Canada. 25 April 2012. Retrieved 29 May 2022.
5. "Summary Basis of Decision (SBD) for Libtayo". Health Canada. 23 October 2014. Retrieved 29 May 2022.
6. ^ "Libtayo- cemiplimab-rwlc injection". DailyMed. 25 June 2020. Retrieved 16 August 2020.
7. ^ "FDA approves first treatment for advanced form of the second most common skin cancer". U.S. Food and Drug Administration. 28 September 2018. Retrieved 7 August 2020. This article incorporates text from this source, which is in the public domain.
8. ^ "Libtayo EPAR". European Medicines Agency (EMA). 24 April 2019. Retrieved 7 August 2020. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
9. Lee A, Duggan S, Deeks ED (June 2020). "Cemiplimab: A Review in Advanced Cutaneous Squamous Cell Carcinoma". Drugs. 80 (8): 813–819. doi:10.1007/s40265-020-01302-2. PMID 32306208. S2CID 215804809.
10. New PD-1 Inhibitor OK'd for Cutaneous SCC - Sixth PD-1/PD-L1 checkpoint inhibitor approved by agency 2018
11. "FDA approves cemiplimab-rwlc in combination with platinum-based chemotherapy for non-small cell lung cancer". U.S. Food and Drug Administration. 8 November 2022. Retrieved 20 December 2022. This article incorporates text from this source, which is in the public domain.
12. "Isatuximab in Combination With Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients". ClinicalTrials.gov. 21 June 2017. Retrieved 7 August 2020.
13. "History of Changes for Study: NCT03194867". ClinicalTrials.gov. 2 June 2020. Retrieved 7 August 2020.
14. "A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer". ClinicalTrials.gov. 12 February 2018. Retrieved 7 August 2020.
15. "History of Changes for Study: NCT03430063". ClinicalTrials.gov. 13 April 2020. Retrieved 7 August 2020.
16. Sanofi and Regeneron Halt Cervical Cancer Trial Early Due to Dazzling Results, Plan to Submit to Regulators Biospace 15 March 2021
17. Regeneron Pharmaceuticals (11 March 2022). "An Open-Label, Randomized, Phase 3 Clinical Trial of REGN2810 Versus Investigator's Choice of Chemotherapy in Recurrent or Metastatic Cervical Carcinoma". Sanofi.
18. "Libtayo: Pending EC decision - European Medicines Agency". European Medicines Agency. 13 October 2022. Archived from the original on 14 October 2022. Retrieved 13 October 2022.
19. Gross ND, Miller DM, Khushalani NI, Divi V, Ruiz ES, Lipson EJ, et al. (October 2022). "Neoadjuvant Cemiplimab for Stage II to IV Cutaneous Squamous-Cell Carcinoma". The New England Journal of Medicine. 387 (17): 1557–1568. doi:10.1056/NEJMoa2209813. PMC 9844515. PMID 36094839.

• Medicine

• Monoclonal antibodies for tumors
• Sanofi