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Erschienen in: Drugs 5/2019

01.04.2019 | AdisInsight Report

Toripalimab: First Global Approval

verfasst von: Susan J. Keam

Erschienen in: Drugs | Ausgabe 5/2019

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Abstract

Toripalimab, a recombinant, humanized programmed death receptor-1 (PD-1) monoclonal antibody that binds to PD-1 and prevents binding of PD-1 with programmed death ligands 1 (PD-L1) and 2 (PD-L2), is being developed by Shanghai Junshi Bioscience Co., Ltd in China for the treatment of various cancers. In December 2018, based on positive efficacy results of a phase 2 trial and safety data from several clinical studies, toripalimab received conditional approval in China for the treatment of unresectable or metastatic melanoma that has failed previous systemic therapy. This article summarizes the milestones in the development of toripalimab leading to this first global approval for the treatment of unresectable or metastatic melanoma.
Literatur
1.
Zurück zum Zitat National Medical Products Administration. The first domestic PD-1 antibody drug, treipril monoclonal antibody injection, was approved for marketing [media release]. 17 Dec 2018. National Medical Products Administration. The first domestic PD-1 antibody drug, treipril monoclonal antibody injection, was approved for marketing [media release]. 17 Dec 2018.
2.
Zurück zum Zitat Shanghai Junshi Biosciences Co. Ltd. China’s first self-developed PD-1 monoclonal antibody, Treripril monoclonal antibody, was approved for marketing, and Junshi Biotechnology promoted China’s accelerated entry into a new era of tumor immunotherapy [media release]. 17 Dec 2018. http://junshipharma.com/News.html. Shanghai Junshi Biosciences Co. Ltd. China’s first self-developed PD-1 monoclonal antibody, Treripril monoclonal antibody, was approved for marketing, and Junshi Biotechnology promoted China’s accelerated entry into a new era of tumor immunotherapy [media release]. 17 Dec 2018. http://​junshipharma.​com/​News.​html.
3.
Zurück zum Zitat Fu J, Wang F, Dong LH, et al. Preclinical evaluation of the efficacy, pharmacokinetics and immunogenicity of JS-001, a programmed cell death protein-1 (PD-1) monoclonal antibody. Acta Pharmacol Sin. 2017;38(5):710–8.CrossRefPubMedPubMedCentral Fu J, Wang F, Dong LH, et al. Preclinical evaluation of the efficacy, pharmacokinetics and immunogenicity of JS-001, a programmed cell death protein-1 (PD-1) monoclonal antibody. Acta Pharmacol Sin. 2017;38(5):710–8.CrossRefPubMedPubMedCentral
5.
Zurück zum Zitat Shanghai Junshi Bioscience Co. Ltd. Toripalimab monoclonal antibody injection: Chinese prescribing information; 2019. Shanghai Junshi Bioscience Co. Ltd. Toripalimab monoclonal antibody injection: Chinese prescribing information; 2019.
7.
Zurück zum Zitat Chi Z, Tang B, Sheng X, et al. A phase II study of JS001, a humanized PD-1 mAb, in patients with advanced melanoma in China [abstract no. 9539]. J Clin Oncol. 2018;36(15 Suppl.). Chi Z, Tang B, Sheng X, et al. A phase II study of JS001, a humanized PD-1 mAb, in patients with advanced melanoma in China [abstract no. 9539]. J Clin Oncol. 2018;36(15 Suppl.).
8.
Zurück zum Zitat Si L, Kong Y, Xu X, et al. Prevalence of BRAF V600E mutation in Chinese melanoma patients: large scale analysis of BRAF and NRAS mutations in a 432-case cohort. Eur J Cancer. 2012;48(1):94–100.CrossRefPubMed Si L, Kong Y, Xu X, et al. Prevalence of BRAF V600E mutation in Chinese melanoma patients: large scale analysis of BRAF and NRAS mutations in a 432-case cohort. Eur J Cancer. 2012;48(1):94–100.CrossRefPubMed
9.
Zurück zum Zitat Hutchison China MediTech Ltd. Chi-Med enters into multiple collaborations to evaluate combinations of surufatinib and fruquintinib with PD-1 checkpoint inhibitors [media release]. 29 Nov 2018. Hutchison China MediTech Ltd. Chi-Med enters into multiple collaborations to evaluate combinations of surufatinib and fruquintinib with PD-1 checkpoint inhibitors [media release]. 29 Nov 2018.
10.
Zurück zum Zitat CSPC Pharmaceutical Group Ltd. Product co-development and strategic collaboration agreement [media release]. 10 Jul 2018. CSPC Pharmaceutical Group Ltd. Product co-development and strategic collaboration agreement [media release]. 10 Jul 2018.
12.
Zurück zum Zitat Tang B, Yan X, Sheng X, et al. Safety and clinical activity with an anti-PD-1 antibody JS001 in advanced melanoma or urologic cancer patients. J Hematol Oncol. 2019;12(1):7.CrossRefPubMedPubMedCentral Tang B, Yan X, Sheng X, et al. Safety and clinical activity with an anti-PD-1 antibody JS001 in advanced melanoma or urologic cancer patients. J Hematol Oncol. 2019;12(1):7.CrossRefPubMedPubMedCentral
13.
Zurück zum Zitat Wang FH, Ren C, Zhang Y, et al. Phase Ia study of a humanized anti-PD-1 monoclonal antibody (JS001) in Chinese patients with refractory solid tumors [abstract no. 1186P]. Ann Oncol. 2017;28(Suppl. 5):v420–1. Wang FH, Ren C, Zhang Y, et al. Phase Ia study of a humanized anti-PD-1 monoclonal antibody (JS001) in Chinese patients with refractory solid tumors [abstract no. 1186P]. Ann Oncol. 2017;28(Suppl. 5):v420–1.
14.
Zurück zum Zitat Guo J, Sheng X, Si L, et al. A phase Ib study of JS001, a humanized IgG4 mAb against programmed death-1 (PD-1) combination with axitinib in patients with metastatic mucosal melanoma [abstract no. 9528]. J Clin Oncol. 2018;36(15 Suppl.). Guo J, Sheng X, Si L, et al. A phase Ib study of JS001, a humanized IgG4 mAb against programmed death-1 (PD-1) combination with axitinib in patients with metastatic mucosal melanoma [abstract no. 9528]. J Clin Oncol. 2018;36(15 Suppl.).
15.
Zurück zum Zitat Xu R, Wang FH, Feng FJ, et al. Recombinant humanized anti-PD-1 monoclonal antibody (JS001) in patients with refractory/metastatic nasopharyngeal carcinoma: preliminary results of an open-label phase II clinical study [abstract no. 1150P]. Ann Oncol. 2018;29(Suppl. 8):viii409. Xu R, Wang FH, Feng FJ, et al. Recombinant humanized anti-PD-1 monoclonal antibody (JS001) in patients with refractory/metastatic nasopharyngeal carcinoma: preliminary results of an open-label phase II clinical study [abstract no. 1150P]. Ann Oncol. 2018;29(Suppl. 8):viii409.
16.
Zurück zum Zitat Sheng X, Chi Z, Cui C, et al. Preliminary results from patients with metastatic urothelial carcinoma (UC) in a phase 2 study of JS001, an anti-PD-1 monoclonal antibody [abstract no. e16505]. J Clin Oncol. 2018;36(15 Suppl.). Sheng X, Chi Z, Cui C, et al. Preliminary results from patients with metastatic urothelial carcinoma (UC) in a phase 2 study of JS001, an anti-PD-1 monoclonal antibody [abstract no. e16505]. J Clin Oncol. 2018;36(15 Suppl.).
17.
Zurück zum Zitat Xu RH, Wang F, Shi J, et al. Recombinant humanized anti-PD-1 monoclonal antibody (JS001) as salvage treatment for advanced esophageal squamous cell carcinoma: preliminary results of an open-label, multi-cohort, phase Ib/II clinical study [abstract no. 116]. J Clin Oncol. 2018;36(4 Suppl.). Xu RH, Wang F, Shi J, et al. Recombinant humanized anti-PD-1 monoclonal antibody (JS001) as salvage treatment for advanced esophageal squamous cell carcinoma: preliminary results of an open-label, multi-cohort, phase Ib/II clinical study [abstract no. 116]. J Clin Oncol. 2018;36(4 Suppl.).
18.
Zurück zum Zitat Xu RH, Wang F, Xu N, et al. Recombinant humanized anti-PD-1 monoclonal antibody (JS001) as salvage treatment for advanced gastric adenocarcinoma: preliminary results of an open-label, multi-cohort, phase Ib/II clinical study [abstract no. 108]. J Clin Oncol. 2018;36(4 Suppl.). Xu RH, Wang F, Xu N, et al. Recombinant humanized anti-PD-1 monoclonal antibody (JS001) as salvage treatment for advanced gastric adenocarcinoma: preliminary results of an open-label, multi-cohort, phase Ib/II clinical study [abstract no. 108]. J Clin Oncol. 2018;36(4 Suppl.).
19.
Zurück zum Zitat Bian L, Zhang H, Wang T, et al. A phase I study of JS001, a humanized PD-1mAb in patients with advanced triple negative breast cancer [abstract no. e15093]. J Clin Oncol. 2018;36(15 Suppl.). Bian L, Zhang H, Wang T, et al. A phase I study of JS001, a humanized PD-1mAb in patients with advanced triple negative breast cancer [abstract no. e15093]. J Clin Oncol. 2018;36(15 Suppl.).
20.
Zurück zum Zitat Yang S, Yang J, Han X, et al. Effect of JS001, a monoclonal antibody targeting programed death-1 (PD-1), on responses and disease control in patients with advanced or refractory alveolar soft part sarcoma: results from a phase 1 trial [abstract no. 11572]. J Clin Oncol. 2018;36(15 Suppl.). Yang S, Yang J, Han X, et al. Effect of JS001, a monoclonal antibody targeting programed death-1 (PD-1), on responses and disease control in patients with advanced or refractory alveolar soft part sarcoma: results from a phase 1 trial [abstract no. 11572]. J Clin Oncol. 2018;36(15 Suppl.).
21.
Zurück zum Zitat Zhang P, Lu M, Li J. Efficacy and safety of PD-1 blockade with JS001 in patients with advanced neuroendocrine neoplasms: a non-randomized, open-label, phase Ib trial [abstract no. 1309O]. Ann Oncol. 2018;29(Suppl. 8):viii468. Zhang P, Lu M, Li J. Efficacy and safety of PD-1 blockade with JS001 in patients with advanced neuroendocrine neoplasms: a non-randomized, open-label, phase Ib trial [abstract no. 1309O]. Ann Oncol. 2018;29(Suppl. 8):viii468.
Metadaten
Titel
Toripalimab: First Global Approval
verfasst von
Susan J. Keam
Publikationsdatum
01.04.2019
Verlag
Springer International Publishing
Erschienen in
Drugs / Ausgabe 5/2019
Print ISSN: 0012-6667
Elektronische ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-019-01076-2

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