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
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
- ^ 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.
- ^ 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.
- ^ 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.
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