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Erschienen in: Drugs 6/2020

01.04.2020 | AdisInsight Report

Tislelizumab: First Approval

verfasst von: Arnold Lee, Susan J. Keam

Erschienen in: Drugs | Ausgabe 6/2020

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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.
Literatur
1.
Zurück zum Zitat 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.CrossRef 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.CrossRef
2.
Zurück zum Zitat 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.CrossRef 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.CrossRef
3.
Zurück zum Zitat 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. 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.
5.
7.
Zurück zum Zitat 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. 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.
10.
Zurück zum Zitat BeiGene. BeiGene and Boehringer Ingelheim announce commercial supply agreement for anti-PD-1 antibody tislelizumab. [media release] 9 Jan 2018. http://www.beigene.com. 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.
Zurück zum Zitat 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. 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.
Zurück zum Zitat BeiGene. US Securities and Exchange Comission Form 10-K, BeiGene, LTD. Annual Filings. 2019. BeiGene. US Securities and Exchange Comission Form 10-K, BeiGene, LTD. Annual Filings. 2019.
13.
Zurück zum Zitat 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). 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.
Zurück zum Zitat 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). 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.
Zurück zum Zitat 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). 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.
Zurück zum Zitat 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). 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.
Zurück zum Zitat 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. 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.
Zurück zum Zitat 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. 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.
Zurück zum Zitat 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. 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.
Zurück zum Zitat 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. 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.
Zurück zum Zitat 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. 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.
Zurück zum Zitat 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. 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.
Zurück zum Zitat 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. 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.
25.
Zurück zum Zitat 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. 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.
Zurück zum Zitat 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. 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.
Zurück zum Zitat 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.CrossRef 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.CrossRef
28.
Zurück zum Zitat 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. 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.
Zurück zum Zitat 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). 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.
Zurück zum Zitat 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. 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.
Zurück zum Zitat BeiGene. Priority review granted to BeiGene's New Drug Applications for zanubrutinib and tislelizumab in China. [media release] 15 Nov 2018. http://beigene.com. 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.
Zurück zum Zitat 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. 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.
Zurück zum Zitat 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. 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.
Metadaten
Titel
Tislelizumab: First Approval
verfasst von
Arnold Lee
Susan J. Keam
Publikationsdatum
01.04.2020
Verlag
Springer International Publishing
Erschienen in
Drugs / Ausgabe 6/2020
Print ISSN: 0012-6667
Elektronische ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-020-01286-z

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