Toripalimab

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Toripalimab
Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetPD-1
Clinical data
Trade namesLoqtorzi
Other namesToripalimab-tpzi
License data
Drug classAntineoplastic
ATC code
Legal status
Legal status
Identifiers
CAS Number
UNII
KEGG
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] Toripalimab 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]

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. ^ a b c d "Loqtorzi- toripalimab injection". DailyMed. 23 October 2023. Retrieved 20 November 2023.
  2. ^ "Loqtorzi- toripalimab-tpzi injection". DailyMed. 27 October 2023. Retrieved 20 November 2023.
  3. ^ a b c d e f g h i "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. ^ a b 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.

External links

  • 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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