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Amivantamab: First Approval

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Abstract

Amivantamab (amivantamab-vmjw; Rybrevant™), a bispecific monoclonal antibody targeting epidermal growth factor receptor (EGFR) and mesenchymal epithelial transition factor (MET), is being developed by Janssen Biotech for the treatment of non-small cell lung cancer (NSCLC). On 21 May 2021, amivantamab received its first approval in the USA for the treatment of adult patients with locally advanced or metastatic NSCLC harbouring EGFR Exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. Amivantamab is in preregistration for NSCLC in the EU, Australia, Japan, Canada, Switzerland and China. This article summarizes the milestones in the development of amivantamab leading to this first approval for NSCLC.

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References

  1. Neijssen J, Cardoso RMF, Chevalier KM, et al. Discovery of amivantamab (JNJ-61186372), a bispecific antibody targeting EGFR and MET. J Biol Chem. 2021. https://doi.org/10.1016/j.jbc.2021.100641.

    Article  PubMed  PubMed Central  Google Scholar 

  2. Moores SL, Chiu ML, Bushey BS, et al. A novel bispecific antibody targeting EGFR and cMet is effective against EGFR inhibitor-resistant lung tumors. Cancer Res. 2016;76(13):3942–53.

    Article  CAS  Google Scholar 

  3. Grugan KD, Dorn K, Jarantow SW, et al. Fc-mediated activity of EGFR x c-Met bispecific antibody JNJ-61186372 enhanced killing of lung cancer cells. MAbs. 2017;9(1):114–26.

    Article  CAS  Google Scholar 

  4. Janssen Biotech Inc. RYBREVANT (amivantamab-vmjw) injection, for intravenous use: US prescribing information. 2021. https://www.accessdata.fda.gov/. Accessed 11 Jun 2021.

  5. US Food & Drug Administration. FDA approves first targeted therapy for subset of non-small cell lung cancer [media release]. https://www.fda.gov/. 21 May 2021.

  6. Guardant Health. Guardant Health announces collaboration with Janssen to develop liquid biopsy companion diagnostic [media release]. www.guardanthealth.com. 8 Jul 2020.

  7. Halozyme Therapeutics. Halozyme Therapeutics enters a global collaboration with janssen to develop and commercialize subcutaneous products using ENHANZE™ technology. [media release]. http://www.halozyme.com. 17 Dec 2014.

  8. Halozyme Therapeutics. United States Securities and Exchange Commission Form 10-Q. 2020. https://www.sec.gov/. 10 Jun 2021.

  9. Genmab AS. Genmab enters broad collaboration with Janssen Biotech, Inc. for DuoBody platform [media release]. http://www.genmab.com. 12 Jul 2012.

  10. Genmab. Genmab announces expansion of DuoBody platform collaboration with Janssen Biotech, Inc [media release]. http://www.genmab.com. 4 Dec 2013.

  11. Vijayaraghavan S, Lipfert L, Chevalier K, et al. Amivantamab (JNJ-61186372), an Fc enhanced EGFR/cMet bispecific antibody, induces receptor downmodulation and antitumor activity by monocyte/macrophage trogocytosis. Mol Cancer Ther. 2020;19(10):2044–56.

    Article  CAS  Google Scholar 

  12. Yun J, Lee SH, Kim SY, et al. Antitumor activity of amivantamab (JNJ-61186372), an EGFR-MET bispecific antibody, in diverse models of EGFR Exon 20 insertion-driven NSCLC. Cancer Discov. 2020;10(8):1194–209.

    CAS  PubMed  Google Scholar 

  13. Lee SH, Yun J, Jeong SY, et al. JNJ-61186372, a novel EGFR/c-Met bispecific antibody, exhibits potent antitumor activity in broad-spectrum of acquired resistance to EGFR-TKIs [abstract no. 5198]. Cancer Res. 2020;80(16 Suppl).

  14. Sabari JK, Shu CA, Park K, et al. Amivantamab in post-platinum EGFR Exon 20 insertion mutant non-small cell lung cancer [abstract no. OA04.04]. J Thorac Oncol. 2021;16(3 Suppl):S108–9.

    Article  Google Scholar 

  15. Cho BC, Lee KH, Cho EK, et al. Amivantamab (JNJ-61186372), an EGFR-MET bispecific antibody, in combination with lazertinib, a 3rd-generation tyrosine kinase inhibitor (TKI), in advanced EGFR NSCLC [abstract no. 1258O]. Ann Oncol. 2020;31(4 Suppl):S813.

    Article  Google Scholar 

  16. Agrawal T, Artis E, Xie J, et al. PAPILLON: randomized phase 3 study of amivantamab plus chemotherapy vs chemotherapy alone in EGFR Exon20ins NSCLC [abstract no. P76.74]. J Thorac Oncol. 2021;16(3 Suppl):S621.

    Article  Google Scholar 

  17. Shreeve SM, Martinez M, Verheijen RB, et al. MARIPOSA: randomized phase 3 study of first-line amivantamab + lazertinib vs osimertinib vs lazertinib in EGFR-mutant NSCLC [abstract no. P76.73]. J Thorac Oncol. 2021;16(3 Suppl):S620–1.

    Article  Google Scholar 

  18. Goto K, Hida T, Funami N, et al. A phase 1/1b study of lazertinib as monotherapy and in combination with amivantamab in advanced EGFR-Mutated NSCLC [abstract no. P15.03]. J Thorac Oncol. 2021;16(3 Suppl):S344–5.

    Article  Google Scholar 

  19. US Food & Drug Administration. FDA grants accelerated approval to amivantamab-vmjw for metastatic non-small cell lung cancer [media release]. https://www.fda.gov/. 21 May 2021.

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Correspondence to Yahiya Y. Syed.

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

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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. Yahiya. Y. Syed is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

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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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Syed, Y.Y. Amivantamab: First Approval. Drugs 81, 1349–1353 (2021). https://doi.org/10.1007/s40265-021-01561-7

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