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Cemiplimab: First Global Approval

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Abstract

Cemiplimab (LIBTAYO®; cemiplimab-rwlc), a human programmed death receptor-1 (PD-1) monoclonal antibody that binds to PD-1 and blocks its interaction with programmed death ligands 1 (PD-L1) and 2 (PD-L2), is being developed by Regeneron Pharmaceuticals and Sanofi Genzyme. The drug is being investigated as a treatment for various cancers and in September 2018 received approval in the USA for the treatment of patients with metastatic cutaneous squamous cell carcinoma or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation. This article summarizes the milestones in the development of cemiplimab leading to this first global approval for the treatment of advanced cutaneous squamous cell carcinoma.

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References

  1. 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  Google Scholar 

  2. Regeneron Pharmaceuticals. Libtayo (cemiplimab): US prescribing information. 2018. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761097s000lbl.pdf. Accessed 2018.

  3. FDA. FDA approves first treatment for advanced form of the second most common skin cancer. [Media release 28 Sep 2018]. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm622044.htm.

  4. Regeneron Pharmaceuticals. Regeneron and Sanofi launch major new immuno-oncology collaboration. [Media release 28 Jul 2015]. http://www.regeneron.com.

  5. Sanofi. Sanofi and Regeneron to accelerate and expand investment for cemiplimab and dupilumab development programs. [Media release 8 Jan 2018]. http://www.sanofi.com.

  6. Regeneron Pharmaceuticals. Regeneron and SillaJen announce immuno-oncology clinical study agreement for combination treatment in kidney cancer. [Media release 8 May 2017]. http://www.regeneron.com.

  7. Regeneron Pharmaceuticals. Regeneron and Inovio enter immuno-oncology clinical study agreement for glioblastoma combination therapy. [Media release 8 May 2017]. http://www.regeneron.com.

  8. Regeneron Pharmaceuticals. Regeneron and ISA pharmaceuticals announce strategic immuno-oncology collaboration. [Media release 18 Dec 2017]. http://www.regeneron.com.

  9. 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  Google Scholar 

  10. Owonikoko TK, Papadopoulos KP, Johnson ML et al. Phase 1 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 1292P plus poster]. In: 2018 European Society for Medical Oncology Congress; 2018.

  11. Rischin D, Gil-Martin M, Gonzalez-Martin A, et al. Cemiplimab, a human PD-1 monoclonal antibody, in patients with recurrent or metastatic cervical cancer: interim data from phase 1 cohorts [abstract no. 958P plus poster]. In: 2018 European Society for Medical Oncology Congress. 2018.

  12. Tewari KS, Vergote I, Oaknin A, et al. GOG 3016/ENGOT-cx9: an open-label, multi-national, randomized, phase 3 trial of cemiplimab, an anti-PD-1, versus investigator’s choice (IC) chemotherapy in ≥ 2 line recurrent or metastatic cervical cancer [abstract no. TPS5600 and Poster]. J Clin Oncol. 2018;15:Suppl.

    Google Scholar 

  13. Pishvaian MJ, Weiss GJ, Falchook GS, et al. Cemiplimab, a human monoclonal anti-PD-1, in patients with advanced or metastatic hepatocellular carcinoma (HCC): data from an expansion cohort in a phase 1 study [abstract no. 1151P plus poster]. In: 2018 European Society for Medical Oncology Congress. 2018.

  14. Moreno V, Gil-Martin M, Johnson M, et al. Cemiplimab, a human monoclonal anti-PD-1, plus radiotherapy in advanced non-small-cell lung cancer (NSCLC): results from a phase 1 expansion cohort (EC 2) [abstract no. 1162P plus poster]. In: 2018 European Society for Medical Oncology Congress. 2018.

  15. Babiker H, Brana I, Mahadevan D, et al. Phase 1 expansion cohort results of cemiplimab, a human PD-1 monoclonal antibody, in combination with radiotherapy, cyclophosphamide and GM-CSF, in patients with recurrent or metastatic head and neck squamous cell carcinoma [abstract no. 1171P plus poster]. In: 2018 European Society for Medical Oncology Congress. 2018.

  16. Topp MS, Borchmann P, Wagner-Johnston ND, et al. Safety and preliminary antitumor activity of the anti-PD-1 monoclonal antibody REGN2810 alone or in combination with REGN1979, an anti-CD20 × anti-CD3 bispecific antibody, in patients with B-lymphoid malignancies [abstract no]. Blood. 2017;130(Suppl 1):1495.

    Google Scholar 

  17. Papadopoulos KP, Lakhani NJ, Johnson ML, et al. A study of REGN3767, an anti-LAG-3 antibody, alone and in combination with cemiplimab (REGN2810), an anti-PD1 antibody, in advanced cancers [abstract no. TPS3127]. J Clin Oncol. 2018;36:15 Suppl.

    Google Scholar 

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Authors and Affiliations

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

    Anthony Markham & Sean Duggan

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  1. Anthony Markham
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  2. Sean Duggan
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Correspondence to Anthony Markham.

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Funding

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

Conflicts of interest

During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. A. Markham, a contracted employee of Adis/Springer, and S. Duggan, a salaried employee of Adis/Springer, are responsible for the article content and declare no relevant conflicts of interest.

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This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

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Markham, A., Duggan, S. Cemiplimab: First Global Approval. Drugs 78, 1841–1846 (2018). https://doi.org/10.1007/s40265-018-1012-5

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