Skip to main content
SpringerLink
Log in

Tislelizumab: First Approval

  • AdisInsight Report
  • Published:
Drugs Aims and scope Submit manuscript

Abstract

Tislelizumab (百泽安®;替雷利珠单抗; Tileilizhu Dankang Zhusheye) is an anti-human programmed death receptor-1 (PD-1) monoclonal IgG4 antibody that is being developed by BeiGene as an immunotherapeutic, anti-neoplastic drug. Tislelizumab has been investigated in haematological cancers and advanced solid tumours, leading to its approval in December 2019 in China for patients with relapsed or refractory classical Hodgkin’s lymphoma after at least second-line chemotherapy. This article summarises the major milestones in the development of tislelizumab for this first approval for classical Hodgkin’s lymphoma, and its potential upcoming approvals in other indications.

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

References

  1. Chen X, Song X, Li K, et al. FcγR-binding is an important functional attribute for immune checkpoint antibodies in cancer immunotherapy. Front Immunol. 2019;10:292.

    Article  CAS  Google Scholar 

  2. Zhang T, Song X, Xu L, et al. The binding of an anti-PD-1 antibody to FcgammaRIota has a profound impact on its biological functions. Cancer Immunol Immunother. 2018;67(7):1079–90.

    Article  CAS  Google Scholar 

  3. BeiGene. China National Medical Products Administration approves BeiGene’s tislelizumab for patients with classical Hodgkin’s lymphoma who have received at least two prior therapies. [media release] 27 Dec 2019. http://www.beigene.com.

  4. BeiGene. Tislelizumab; China prescribing information [Chinese]. 2019. http://drugs.medlive.cn/drugref/html/21697.shtml. Accessed 10 Mar 2020.

  5. BeiGene. BeiGene announces closing of global strategic oncology collaboration with Celgene Corporation. [media release] 31 Aug 2017. http://www.beigene.com.

  6. BeiGene. BeiGene reports second quarter 2017 financial results. [media release] 9 Aug 2019. http://www.beigene.com.

  7. Celgene Corporation. Celgene Corporation enters into global strategic immuno-oncology collaboration with BeiGene to advance PD-1 inhibitor program for solid tumor cancers. [media release] 5 Jul 2017. http://www.beigene.com.

  8. BeiGene. BeiGene regains full global rights to its investigational anti-PD-1 antibody tislelizumab. [media release] 17 Jun 2019. http://www.beigene.com.

  9. BeiGene. BeiGene reports second quarter 2019 financial results. [media release] 8 Aug 2019. http://www.beigene.com.

  10. BeiGene. BeiGene and Boehringer Ingelheim announce commercial supply agreement for anti-PD-1 antibody tislelizumab. [media release] 9 Jan 2018. http://www.beigene.com.

  11. BioAtla, BeiGene. BioAtla and BeiGene form worldwide collaboration to develop and commercialize novel conditionally active biologic CTLA-4 therapy. [media release] 9 Apr 2019. http://www.beigene.com.

  12. BeiGene. US Securities and Exchange Comission Form 10-K, BeiGene, LTD. Annual Filings. 2019.

  13. Zhang T, Song J, Li Y, et al. Antihuman PD-1 antibody BGB-A317 exhibits potent immune cell activation [abstract no. 2226]. Cancer Research Conference: 107th AACR Annual Meeting 2016;76(Suppl 14).

  14. Feng Y, Hong Y, Sun H, et al. The molecular binding mechanism of tislelizumab, an investigational anti-PD-1 antibody, is differentiated from pembrolizumab and nivolumab [abstract no. 2383]. Cancer Research Conference: AACR Annual Meeting. 2019;79(Suppl 13).

  15. Wu X, Zhang T, Fu C, et al. Activation of tumor infiltrating lymphocytes from colorectal cancer and colorectal liver metastasis patients by anti-human PD-1 antibody BGB-A317 in a 3D spheroid system [abstract no. e14560]. JCO Conference. 2016;34(Suppl 15).

  16. Luo L, Wu X, Zhang T, et al. Investigation of T cell activation by anti-human PD-1 antibodies nivolumab, pembrolizumab and BGB-A317 using tumor-infiltrating lymphocytes (TILs) from colorectal cancer and colorectal liver metastasis patients [abstract no. 5626]. AACR Annual Meeting. 2017;77(Suppl 13).

  17. Song Y, Gao Q, Zhang H, et al. Treatment of relapsed or refractory classical Hodgkin lymphoma with the anti-PD-1, tislelizumab: results of a phase 2, single-arm, multicenter study. Leukemia. 2019.

  18. Ye D, Liu J, Zhou A, et al. First report of efficacy and safety from a phase II trial of tislelizumab, an anti-PD-1 antibody, for the treatment of PD-L1 + locally advanced or metastatic urothelial carcinoma (UC) in Asian patients [abstract no. 920P]. Ann Oncol. 2019;30(Suppl 5):v367.

  19. BeiGene. BeiGene announces clinical results on tislelizumab presented at the 22nd Annual Meeting of the Chinese Society of Clinical Oncology (CSCO). [media release] 22 Sep 2019. http://beigene.com.

  20. BeiGene. BeiGene announces updated phase 1A/1B data on tislelizumab presented at the European Society for Medical Oncology Immuno-Oncology Congress. [media release] 15 Dec 2018. http://beigene.com.

  21. BeiGene. BeiGene announces clinical data on tislelizumab presented at European Society for Medical Oncology (ESMO) Asia 2019 Congress. [media release] 23 Nov 2019. http://www.beigene.com.

  22. Deva S, Lee JS, Lin CC, et al. A phase Ia/Ib trial of tislelizumab, an anti-PD-1 antibody (ab), in patients (pts) with advanced solid tumors [abstract no. 70O]. Ann Oncol. 2018;29(Suppl 10):x33.

  23. BeiGene. BeiGene announces that the phase 3 clinical trial of its anti-PD-1 antibody tislelizumab in patients with first- line squamous non-small cell lung cancer met the primary endpoint of progression-free survival at interim analysis. [media release] 21 Jan 2020. http://beigene.com.

  24. BeiGene. Data on file. 2020.

  25. Tam CS, Cull G, Opat S, et al. An update on safety and preliminary efficacy of highly specific bruton tyrosine kinase (BTK) Inhibitor zanubrutinib in combination with PD-1 inhibitor tislelizumab in patients with previously treated B-Cell lymphoid malignancies. 61st ASH Annual Meeting 2019;134(Suppl 1):1594.

  26. BeiGene. BeiGene announces clinical data on investigational anti-PD-1 antibody tislelizumab in combination with sitravatinib at European Society for Medical Oncology Immuno-Oncology (ESMO I-O) Congress 2019. [media release] 13 Dec 2019. http://beigene.com.

  27. Friedlander M, Meniawy T, Markman B, et al. Pamiparib in combination with tislelizumab in patients with advanced solid tumours: results from the dose-escalation stage of a multicentre, open-label, phase 1a/b trial. Lancet Oncol. 2019;20(9):1306–15.

    Article  CAS  Google Scholar 

  28. Meniawy T, Richardson G, Townsend A, et al. Preliminary results from a subset of patients (pts) with advanced ovarian cancer (OC) in a dose-escalation/expansion study of BGB-A317, an anti-PD-1 monoclonal antibody (mAb) [abstract no. 389P]. Ann Oncol. 2017;28(Suppl 5):v130.

  29. Desai J, Markman B, Friedlander M, et al. Long-term exposure (LTE) to tislelizumab, an investigational anti-PD-1 antibody, in a first-in-human phase I study [abstract no. CT084]. AACR Annual Meeting. 2019;79(Suppl 13).

  30. BeiGene. BeiGene announces acceptance of New Drug Application for anti-PD-1 antibody tislelizumab in Hodgkins lymphoma in China. [media release] 31 Aug 2018. http://beigene.com.

  31. BeiGene. Priority review granted to BeiGene's New Drug Applications for zanubrutinib and tislelizumab in China. [media release] 15 Nov 2018. http://beigene.com.

  32. BeiGene. Priority review granted to BeiGenes supplemental New Drug Application in China for tislelizumab in urothelial carcinoma. [media release] 7 Jul 2019. http://beigene.com.

  33. BeiGene. BeiGene announces acceptance of a supplemental New Drug Application in China for tislelizumab in urothelial carcinoma. [media release] 30 May 2019. http://www.beigene.com.

Download references

Author information

Authors and Affiliations

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

    Arnold Lee & Susan J. Keam

Authors
  1. Arnold Lee
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Susan J. Keam
    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.

Conflict 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. Arnold Lee and Susan Keam 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 AdisInsight Report can be found at https://doi.org/10.6084/m9.figshare.11910855.

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.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Lee, A., Keam, S.J. Tislelizumab: First Approval. Drugs 80, 617–624 (2020). https://doi.org/10.1007/s40265-020-01286-z

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40265-020-01286-z

Search

Navigation