Toripalimab

Last updated

Toripalimab
Monoclonal antibody
Type Whole antibody
Source Humanized
Target PD-1
Clinical data
Trade names Loqtorzi
Other namesToripalimab-tpzi
License data
Drug class Antineoplastic
ATC code
Legal status
Legal status
Identifiers
CAS Number
UNII
KEGG
Chemical and physical data
Formula C6548H10104N1728O2054S44
Molar mass 147309.54 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]

Contents

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]

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References

  1. 1 2 3 4 "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. 1 2 3 4 5 6 7 8 9 "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.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  4. 1 2 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.