Toripalimab

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Toripalimab
Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetPD-1
Names
Trade namesLoqtorzi
Other namesToripalimab-tpzi
Clinical data
Drug classAntineoplastic
Legal
License data
Legal status
Chemical and physical data
FormulaC6548H10104N1728O2054S44
Molar mass147309.54 g·mol−1

Toripalimab, sold under the brand name Loqtorzi, is a monoclonal antibody used for the treatment of melanoma and nasopharyngeal carcinoma.[1][3]

It is a recombinant humanized programmed cell death protein 1 (PD-1) monoclonal antibody that acts as a checkpoint inhibitor.[4]

In 2018, toripalimab was approved in China for the treatment of unresectable or metastatic melanoma that has failed previous systemic therapy.[4] In October 2023, the US Food and Drug Administration (FDA) approved toripalimab for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma when used with cisplatin and gemcitabine.[3][5]

Medical uses

Toripalimab is indicated in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma.[1][3] It is also indicated as a single agent for adults with recurrent unresectable or metastatic nasopharyngeal carcinoma with disease progression on or after a platinum-containing chemotherapy.[1][3]

Mechanism of action

Mechanism of toripalimab[6]

The mode of action of Toripalimab(anti-PD-1 antibody) is consistent with binding to PD-1 receptor on T-cells,this in turn blocks interaction between PD-1 and its ligands(PD-L1 and PD-L2). As a consequence of this interaction inhibition, toripalimab permits the immune system to activate and kill the tumor cells[6][7]

History

Efficacy of toripalimab with cisplatin and gemcitabine was evaluated in JUPITER-02 (NCT03581786), a randomized, multicenter, single region, double-blind, placebo-controlled trial in 289 participants with metastatic or recurrent, locally advanced nasopharyngeal carcinoma who had not received previous systemic chemotherapy for recurrent or metastatic disease.[3] Participants were randomized (1:1) to either toripalimab with cisplatin and gemcitabine, followed by toripalimab, or placebo with cisplatin and gemcitabine, followed by placebo.[3]

Efficacy of toripalimab as a single agent was evaluated in POLARIS-02 (NCT02915432), an open-label, multicenter, single country, multicohort trial in 172 participants with unresectable or metastatic nasopharyngeal carcinoma who had received prior platinum-based chemotherapy or had disease progression within six months of completion of platinum-based chemotherapy administered as neoadjuvant, adjuvant, or definitive chemoradiation treatment for locally advanced disease.[3] Participants received toripalimab until disease progression per RECIST v1.1 or unacceptable toxicity.[3]

The FDA granted the application for toripalimab priority review, breakthrough therapy, and orphan drug designations.[3]

References

  1. ↑ 1.0 1.1 1.2 1.3 "Loqtorzi- toripalimab injection". DailyMed. 23 October 2023. Archived from the original on 16 July 2024. Retrieved 20 November 2023.
  2. ↑ "Loqtorzi- toripalimab-tpzi injection". DailyMed. 27 October 2023. Archived from the original on 16 July 2024. Retrieved 20 November 2023.
  3. ↑ 3.0 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 "FDA approves toripalimab-tpzi for nasopharyngeal carcinoma". U.S. Food and Drug Administration (FDA). 27 October 2023. Archived from the original on 2 November 2023. Retrieved 2 November 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  4. ↑ 4.0 4.1 Keam SJ (April 2019). "Toripalimab: First Global Approval". Drugs. 79 (5): 573–578. doi:10.1007/s40265-019-01076-2. PMID 30805896. S2CID 71147241.
  5. ↑ Li J, Zhang H, Zhu H, Li H (November 2023). "Clinical outcomes and immunological evaluation of toripalimab combination for cancer treatment: A systematic review and meta-analysis of randomized controlled trials". International Immunopharmacology. 125 (Pt B): 111176. doi:10.1016/j.intimp.2023.111176. PMID 37948860. S2CID 265121325.
  6. ↑ 6.0 6.1 Gao, Yue; Zhong, Mingyao; Gan, Lulu; Xiang, Cheng; Li, Ling; Yan, Yimin (5 September 2023). "Immune checkpoint inhibitor– and phosphatidylinositol-3-kinase inhibitor–related diabetes induced by antineoplastic drugs: two case reports and a literature review". Frontiers in Endocrinology. 14: 1236946. doi:10.3389/fendo.2023.1236946. ISSN 1664-2392. Archived from the original on 16 July 2024. Retrieved 13 July 2024.
  7. ↑ Rajasekaran, Narendiran; Wang, Xiaoguang; Ravindranathan, Sruthi; Chin, Daniel J.; Tseng, Su-Yi; Klakamp, Scott L.; Widmann, Kate; Kapoor, Varun N.; Vexler, Vladimir; Keegan, Patricia; Yao, Sheng; LaVallee, Theresa; Khare, Sanjay D. (24 February 2024). "Toripalimab, a therapeutic monoclonal anti-PD-1 antibody with high binding affinity to PD-1 and enhanced potency to activate human T cells". Cancer Immunology, Immunotherapy. 73 (3): 60. doi:10.1007/s00262-024-03635-3. ISSN 1432-0851. Archived from the original on 16 July 2024. Retrieved 13 July 2024.

External links

Identifiers:
  • Clinical trial number NCT03581786 for "The Efficacy and Safety Study of TORIPALIMAB INJECTION Combined With Chemotherapy for Nasophapyngeal Cancer" at ClinicalTrials.gov
  • Clinical trial number NCT02915432 for "The Study to Evaluate Toripalimab (JS001) in Patients With Advanced GC, ESCC, NPC, HNSCC" at ClinicalTrials.gov
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