Toripalimab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized |
| Target | PD-1 |
| Clinical data | |
| Trade names | Loqtorzi |
| Other names | Toripalimab-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]
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
[edit]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
[edit]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]
Society and culture
[edit]Legal status
[edit]In July 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Loqtorzi, intended for the treatment of nasopharyngeal carcinoma and esophageal squamous cell carcinoma.[6] The applicant for this medicinal product is TMC Pharma (EU) Limited.[6]
References
[edit]- ^ Jump up to: a b c d "Loqtorzi- toripalimab injection". DailyMed. 23 October 2023. Retrieved 20 November 2023.
- ^ "Loqtorzi- toripalimab-tpzi injection". DailyMed. 27 October 2023. Retrieved 20 November 2023.
- ^ Jump up to: 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.
This article incorporates text from this source, which is in the public domain.
- ^ Jump up to: 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.
- ^ 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.
- ^ Jump up to: a b "Loqtorzi EPAR". European Medicines Agency. 25 July 2024. Retrieved 27 July 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
External links
[edit]- 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
