Difference between revisions of "Toripalimab (Loqtorzi)"

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From the [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/toripalimab NCI Drug Dictionary]: A humanized immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed cell death 1 (programmed death-1; PD-1), with potential immune checkpoint inhibitory and antineoplastic activities. Upon administration, toripalimab binds to PD-1 and inhibits the binding of PD-1 to its ligands, programmed cell death-1 ligand 1 (PD-L1) and PD-1 ligand 2 (PD-L2). This prevents the activation of PD-1 and its downstream signaling pathways. This may restore immune function through the activation of both T cells and T-cell-mediated immune responses against tumor cells.
 
From the [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/toripalimab NCI Drug Dictionary]: A humanized immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed cell death 1 (programmed death-1; PD-1), with potential immune checkpoint inhibitory and antineoplastic activities. Upon administration, toripalimab binds to PD-1 and inhibits the binding of PD-1 to its ligands, programmed cell death-1 ligand 1 (PD-L1) and PD-1 ligand 2 (PD-L2). This prevents the activation of PD-1 and its downstream signaling pathways. This may restore immune function through the activation of both T cells and T-cell-mediated immune responses against tumor cells.
  
==Preliminary data==
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==Diseases for which it is established==
===[[Nasopharyngeal carcinoma]]===
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*[[Nasopharyngeal carcinoma]]
# '''JUPITER-02:''' Mai HQ, Chen QY, Chen D, Hu C, Yang K, Wen J, Li J, Shi YR, Jin F, Xu R, Pan J, Qu S, Li P, Hu C, Liu YC, Jiang Y, He X, Wang HM, Lim WT, Liao W, He X, Chen X, Liu Z, Yuan X, Li Q, Lin X, Jing S, Chen Y, Lu Y, Hsieh CY, Yang MH, Yen CJ, Samol J, Feng H, Yao S, Keegan P, Xu RH. Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 trial. Nat Med. 2021 Sep;27(9):1536-1543. Epub 2021 Aug 2. [https://doi.org/10.1038/s41591-021-01444-0 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34341578/ PubMed] NCT03581786
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==Diseases for which it is used==
 
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*[[Breast cancer, triple negative]]
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*[[Clear cell renal cell carcinoma]]
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*[[Esophageal squamous cell carcinoma]]
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*[[Melanoma]]
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*[[Non-small cell lung cancer, nonsquamous]]
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*[[Non-small cell lung cancer, squamous]]
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*[[Urothelial carcinoma]]
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==History of changes in FDA indication==
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*2023-10-27: Approved with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent, locally advanced [[Nasopharyngeal carcinoma|nasopharyngeal carcinoma (NPC)]]. ''(Based on JUPITER-02)''
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*2023-10-27: Approved as a single agent for adults with recurrent unresectable or metastatic [[Nasopharyngeal carcinoma|NPC]] with disease progression on or after a platinum-containing chemotherapy. ''(Based on POLARIS-02)''
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==History of changes in NMPA indication==
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*2018-12-17: Initial approval
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*2024-04-11: Approved in combination with axitinib for the first-line treatment of patients with medium- to high-risk unresectable or metastatic [[renal cell carcinoma|renal cell carcinoma (RCC)]]. ''(Based on RENOTORCH)''
 
==Also known as==
 
==Also known as==
*'''Code name:''' JS001
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*'''Code names:''' JS-001, TAB-001
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*'''Generic name:''' teriprolizumab, toripalimab-tpzi
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*'''Brand name:''' Loqtorzi, Tuoyi
  
 
[[Category:Drugs]]
 
[[Category:Drugs]]
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[[Category:Anti-PD-1 antibodies]]
 
[[Category:Anti-PD-1 antibodies]]
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[[Category:Breast cancer medications]]
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[[Category:Esophageal squamous cell carcinoma medications]]
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[[Category:Melanoma medications]]
 
[[Category:Nasopharyngeal carcinoma medications]]
 
[[Category:Nasopharyngeal carcinoma medications]]
 
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[[Category:Non-small cell lung cancer, nonsquamous medications]]
[[Category:Investigational drugs]]
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[[Category:Non-small cell lung cancer, squamous medications]]
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[[Category:Urothelial carcinoma medications]]
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[[Category:NMPA approved in 2018]]
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[[Category:FDA approved in 2023]]

Latest revision as of 01:32, 23 May 2024

Mechanism of action

From the NCI Drug Dictionary: A humanized immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed cell death 1 (programmed death-1; PD-1), with potential immune checkpoint inhibitory and antineoplastic activities. Upon administration, toripalimab binds to PD-1 and inhibits the binding of PD-1 to its ligands, programmed cell death-1 ligand 1 (PD-L1) and PD-1 ligand 2 (PD-L2). This prevents the activation of PD-1 and its downstream signaling pathways. This may restore immune function through the activation of both T cells and T-cell-mediated immune responses against tumor cells.

Diseases for which it is established

Diseases for which it is used

History of changes in FDA indication

  • 2023-10-27: Approved with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma (NPC). (Based on JUPITER-02)
  • 2023-10-27: Approved as a single agent for adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy. (Based on POLARIS-02)

History of changes in NMPA indication

  • 2018-12-17: Initial approval
  • 2024-04-11: Approved in combination with axitinib for the first-line treatment of patients with medium- to high-risk unresectable or metastatic renal cell carcinoma (RCC). (Based on RENOTORCH)

Also known as

  • Code names: JS-001, TAB-001
  • Generic name: teriprolizumab, toripalimab-tpzi
  • Brand name: Loqtorzi, Tuoyi