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Zimberelimab: First Approval

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Abstract

Zimberelimab (誉妥®) is an anti-programmed cell death protein-1 (PD-1) monoclonal antibody being developed by Gloria Biosciences, Arcus Biosciences and Taiho Pharmaceutical Co. for the treatment of various cancers including cervical cancer, non-small cell lung cancer and classical Hodgkin’s lymphoma. Based on the results of a phase II trial, zimberelimab was recently approved for marketing in China as treatment for relapsed or refractory classical Hodgkin’s lymphoma. This article summarizes the milestones in the development of zimberelimab leading to this first approval.

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References

  1. Gloria Biosciences. NMPA Approval notification [media release]. 30 Aug 2021. https://www.gloriabio.com.

  2. Gloria Biosciences. Zimberelimab Injection: Chinese Prescribing information 2021.

  3. WuXi PharmaTech Inc., Open Monoclonal Technology Inc. WuXi PharmaTech and Open Monoclonal Technology announce OmniRat(TM) antibody collaboration [media release]. 4 Sep 2012. http://www.wuxibiologics.com.

  4. WuXi PharmaTech Inc., Open Monoclonal Technology Inc. WuXi PharmaTech and Open Monoclonal Technology expand human antibody development and commercial opportunities for Asian regional and global pharmaceutical companies [media release]. 5 Mar 2013. https://www.wuxiapptec.com/.

  5. WuXi Biologics., Harbin Gloria Pharmaceuticals. WuXi Biologics and Gloria Pharmaceuticals announce the licensure of the fully human PD-1 antibody, GLS-010, to Arcus Biosciences [media release]. 17 Aug 2017. http://www.wuxibiologics.com.

  6. Ligand Pharmaceuticals Inc. Ligand to acquire OMT, Inc., a leader in human antibody generation, for $178 million in cash and stock [media release]. 17 Dec 2015. https://investor.ligand.com.

  7. Arcus Biosciences. Arcus Biosciences announces option and license agreement with Taiho Pharmaceutical Co. Ltd [media release]. 19 Sep 2017. http://www.arcusbio.com.

  8. Taiho Pharmaceutical. Taiho Pharmaceutical concludes option and license agreement with Arcus Biosciences [media release]. 20 Sep 2017. http://www.taiho.co.jp.

  9. Arcus Biosciences. Arcus Biosciences and Taiho Pharmaceutical Co., ltd. jointly announce Taiho's exercise of its option for an exclusive license to zimberelimab (AB122) for Its territories in Japan and other Asian countries [media release]. 26 Feb 2020. http://www.arcusbio.com.

  10. Arcus Biosciences. Arcus Biosciences and Infinity Pharmaceuticals announce clinical collaboration to evaluate lead programs in triple-combination studies [media release]. 26 Jun 2018. http://www.arcusbio.com.

  11. Arcus B. Arcus Biosciences and Strata Oncology announce clinical development collaboration for anti-PD-1 antibody AB122 [media release]. 2 May 2019. http://www.arcusbio.com.

  12. Gilead Sciences., Arcus Biosciences. Gilead Sciences and Arcus Biosciences establish 10-year partnership to co- develop and co-commercialize next-generation cancer immunotherapies [media release]. 27 May 2020. http://www.gilead.com.

  13. Gilead Sciences. Gilead Sciences and Arcus Biosciences complete closing of their 10-year partnership to co-develop and co-commercialize next-generation cancer immunotherapies [media release]. 13 Jul 2020. http://www.gilead.com.

  14. Tan JB, Chen C, Chen K, et al. Preclinical characterization of GLS-010 (AB122): A fully humanized clinical-stage anti-PD-1 antibody [abstract no. 4561]. Cancer Res Conf. 2018;78(Suppl 13):4561.

    Article  Google Scholar 

  15. Shen L, Gong J, Xu Y, et al. A novel recombinant human anti-PD-1 monoclonal antibody GLS-010 in patients with advanced cancer: result of a phase Ia clinical trial [abstract no. 65P]. Ann Oncol. 2018;29(Suppl 10):x22–3.

    Article  Google Scholar 

  16. Seitz LC, Rieger A, Berry W, et al. Preliminary results from a phase 1 study of AB122, a programmed cell death-1 (PD-1) inhibitor, in patients with advanced solid malignancies [abstract no. 77P]. Ann Oncol. 2018;29(Suppl 10):x28.

    Article  Google Scholar 

  17. Liu D, Ma C, Lu P, et al. Dose escalation and expansion (phase Ia/Ib) study of GLS-010, a recombinant fully human antiprogrammed death-1 monoclonal antibody for advanced solid tumors or lymphoma. Eur J Cancer. 2021;148:1–13.

    Article  CAS  Google Scholar 

  18. Lin N, Zhang M, Bai H, et al. Efficacy and safety of GLS-010 (zimberelimab) in patients with relapsed or refractory classical Hodgkin lymphoma: a multicenter, single-arm, phase II study. Eur J Cancer. 2021. https://doi.org/10.1016/j.ejca.2021.07.021.

    Article  PubMed  Google Scholar 

  19. Gloria Biosciences. 誉越巅峰-2021年CSCO誉衡生物赛帕利单抗 (誉妥®)卫星会成功召开. 2021. https://mp.weixin.qq.com/s?__biz=MzI2Mjg5NDQzOQ==&mid=2247484951&idx=1&sn=7357813ef7f9dd00cdf059eb3bb7a510&chksm. Accessed 11 Oct

  20. Wu X, Xia L, Zhou Q, et al. GLS-010 (zimberelimab), a novel fully human anti-PD-1 mab in Chinese patients with recurrent/metastatic cervical cancer: results from a multicenter, open-label, single-arm phase II trial [abstract no. 357]. Int J Gynecol Cancer. 2020;30(Suppl 3):A147.

    Google Scholar 

  21. Chaudhry A, Johnson M, Colburn D, et al. A phase II study to evaluate the safety and efficacy of zimberelimab alone, AB154 in combination with zimberelimab, and AB154 in combination with zimberelimab and AB928 in front-line, PD-L1 expressing, non-small cell lung cancer (NSCLC) [abstract no. 1419TiP and poster]. Ann Oncol. 2020;31(Suppl 4):S897.

    Article  Google Scholar 

  22. Manji GA, Wainberg ZA, Krishnan K, et al. ARC-8: Phase I/Ib study to evaluate safety and tolerability of AB680 + chemotherapy +zimberelimab (AB122) in patients with treatment-naive metastatic pancreatic adenocarcinoma (mPDAC) [abstract no. 404]. J Clin Oncol Conf. 2021;39(Suppl 3):404.

    Article  Google Scholar 

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Correspondence to Anthony Markham.

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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. A. Markham 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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Markham, A. Zimberelimab: First Approval. Drugs 81, 2063–2068 (2021). https://doi.org/10.1007/s40265-021-01628-5

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  • DOI: https://doi.org/10.1007/s40265-021-01628-5

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