Skip to main content
SpringerLink
Log in

Cemiplimab: A Review in Advanced Cutaneous Squamous Cell Carcinoma

  • Adis Drug Evaluation
  • Published:
Drugs Aims and scope Submit manuscript

A Correction to this article was published on 30 May 2020

This article has been updated

Abstract

Cemiplimab (Libtayo®) is an antibody immunotherapy that stimulates an anti-cancer response via programmed cell death protein-1 (PD-1) blockade. It is the first approved treatment in the USA and EU for patients with locally advanced (laCSCC) or metastatic (mCSCC) cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiotherapy. Approval was based largely on positive results from the phase II EMPOWER-CSCC 1 trial in this patient population. In this pivotal trial, treatment with intravenous cemiplimab 3 mg/kg once every 2 weeks or 350 mg once every 3 weeks resulted in a clinically significant objective response rate across laCSCC and mCSCC patient groups. Furthermore, responses appear to be durable, as the median duration of response has not yet been reached. Similarly, the median overall survival has also not yet been reached as of the latest data cut-off date. The safety and tolerability profile of cemiplimab was acceptable, with most immune-related adverse events being clinically manageable with appropriate therapy or discontinuation of cemiplimab. Overall, cemiplimab has a durable, clinically significant effect and an acceptable tolerability and safety profile. As the first approved treatment for this indication, cemiplimab represents a welcome therapeutic advance for patients with advanced CSCC.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

Change history

  • 30 May 2020

    The title for the dosage on line 3, which previously read.

References

  1. Rogers HW, Weinstock MA, Feldman SR, et al. Incidence estimate of nonmelanoma skin cancer (keratinocyte carcinomas) in the US population, 2012. JAMA Dermatol. 2015;151(10):1081–6.

    Article  PubMed  Google Scholar 

  2. Karia PS, Han J, Schmults CD. Cutaneous squamous cell carcinoma: estimated incidence of disease, nodal metastasis, and deaths from disease in the United States, 2012. J Am Acad Dermatol. 2013;68(6):957–66.

    Article  PubMed  Google Scholar 

  3. Que SKT, Zwald FO, Schmults CD. Cutaneous squamous cell carcinoma. J Am Acad Dermatol. 2018;78(2):237–47.

    Article  PubMed  Google Scholar 

  4. Patel R, Chang ALS. Immune checkpoint inhibitors for treating advanced cutaneous squamous cell carcinoma. Am J Clin Dermatol. 2019;20(4):477–82.

    Article  PubMed  Google Scholar 

  5. European Medicines Agency. Libtayo (cemiplimab): EU public assessment report. 2019. http://www.ema.europa.eu. Accessed 10 Dec 2019.

  6. Stratigos AJ, Garbe C, Dessinioti C, et al. European interdisciplinary guideline on invasive squamous cell carcinoma of the skin: Part 1. Epidemiology, diagnostics and prevention. Eur J Cancer. 2020. https://doi.org/10.1016/j.ejca.2020.01.007.

    Article  PubMed  Google Scholar 

  7. Tongdee E, Psomadakis C, Marghoob N, et al. Advanced squamous cell carcinoma: what’s new? Curr Derm Rep. 2019;8(3):117–21.

    Article  Google Scholar 

  8. Stratigos A, Garbe C, Lebbe C, et al. Diagnosis and treatment of invasive squamous cell carcinoma of the skin: European consensus-based interdisciplinary guideline. Eur J Cancer. 2015;51(14):1989–2007.

    Article  PubMed  Google Scholar 

  9. Ribero S, Stucci LS, Daniels GA, et al. Drug therapy of advanced cutaneous squamous cell carcinoma: is there any evidence? Curr Opin Oncol. 2017;29(2):129–35.

    Article  CAS  PubMed  Google Scholar 

  10. National Institute for Health and Care Excellence. Cemiplimab for treating metastatic or locally advanced cutaneous squamous cell carcinoma. 2019. http://nice.org.uk. Accessed 10 Dec 2019.

  11. Migden MR, Rischin D, Schmults CD, et al. PD-1 blockade with cemiplimab in advanced cutaneous squamous-cell carcinoma. N Engl J Med. 2018;379(4):341–51.

    Article  CAS  PubMed  Google Scholar 

  12. Regeneron Pharmaceuticals Inc. Libtayo (cemiplimab): US prescribing information. 2019. http://www.regeneron.com. Accessed 10 Dec 2019.

  13. European Medicines Agency. Libtayo (cemiplimab): summary of product characteristics. 2019. http://www.ema.europa.eu/. Accessed 10 Dec 2019.

  14. Sharpe AH, Pauken KE. The diverse functions of the PD1 inhibitory pathway. Nat Rev Immunol. 2018;18(3):153–67.

    Article  CAS  PubMed  Google Scholar 

  15. Burova E, Hermann A, Waite J, et al. Characterization of the anti-PD-1 antibody REGN2810 and its antitumor activity in human PD-1 knock-in mice. Mol Cancer Ther. 2017;16(5):861–70.

    Article  CAS  PubMed  Google Scholar 

  16. Migden MR, Paccaly A, Papadopoulos KP, et al. Pharmacokinetic (PK) analysis of weight-based and fixed dose cemiplimab in patients (pts) with advanced malignancies [abstract no. 1279P plus poster]. Ann Oncol. 2019;30(Suppl 5):v520.

    Article  Google Scholar 

  17. Owonikoko TK, Papadopoulos KP, Johnson ML, et al. Phase I study of cemiplimab, a human monoclonal anti-PD-1, in patients with unresectable locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC): longer follow-up efficacy and safety data [abstract no 71P plus poster]. Ann Oncol. 2018;29(Suppl 10):x25.

    Article  Google Scholar 

  18. Guminski AD, Lim AML, Khushalani NI, et al. Phase 2 study of cemiplimab, a human monoclonal anti-PD-1, in patients with metastatic cutaneous squamous cell carcinoma (mCSCC; Group 1): 12-month follow-up [abstract no. 9526 plus poster]. J Clin Oncol. 2019;37(15 Suppl):9526.

    Article  Google Scholar 

  19. Migden MR, Khushalani NI, Chang ALS, et al. Primary analysis of phase 2 results of cemiplimab, a human monoclonal anti-PD-1, in patients with locally advanced cutaneous squamous cell carcinoma (laCSCC) [abstract no. 6015 plus poster]. J Clin Oncol. 2019;37(15 Suppl):6015.

    Article  Google Scholar 

  20. Rischin D, Lim AM, Schmults CD, et al. Phase 2 study of 2 dosing regimens of cemiplimab, a human monoclonal anti–PD-1, in metastatic cutaneous squamous cell carcinoma (mCSCC) [abstract plus poster]. In: Maui Derm. 2020.

  21. Myers G. Immune-related adverse events of immune checkpoint inhibitors: a brief review. Curr Oncol. 2018;25(5):342–7.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  22. National Comprehensive Cancer Network. Squamous cell skin cancer NCCN Evidence Blocks. 2020. http://www.nccn.org. Accessed 18 Feb 2020.

  23. Stratigos AJ, Garbe C, Dessinioti C, et al. European interdisciplinary guideline on invasive squamous cell carcinoma of the skin: part 2. Treatment. Eur J Cancer. 2020. https://doi.org/10.1016/j.ejca.2020.01.008.

    Article  PubMed  Google Scholar 

Download references

Acknowledgements

During the peer review process, the manufacturer of cemiplimab was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

Author information

Authors and Affiliations

  1. Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand

    Arnold Lee, Sean Duggan & Emma D. Deeks

Authors
  1. Arnold Lee
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Sean Duggan
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Emma D. Deeks
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Arnold Lee.

Ethics declarations

Funding

The preparation of this review was not supported by any external funding.

Conflicts of interest

Arnold Lee, Sean Duggan and Emma Deeks are salaried employees of Adis International Ltd/Springer Nature, are responsible for the article content and declare no relevant conflicts of interest.

Additional information

Enhanced material for this Adis Drug Evaluation can be found at https://doi.org/10.6084/m9.figshare.11987502.

The manuscript was reviewed by: K. Ashack, Department of Dermatology, University of Illinois at Chicago, Chicago, IL, USA; G. Daniels, Department of Medicine, Moores UCSD Cancer Center, La Jolla, CA, USA.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Lee, A., Duggan, S. & Deeks, E.D. Cemiplimab: A Review in Advanced Cutaneous Squamous Cell Carcinoma. Drugs 80, 813–819 (2020). https://doi.org/10.1007/s40265-020-01302-2

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40265-020-01302-2

Search

Navigation