| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized |
| Target | PD-1 |
| Clinical data | |
| Trade names | Loqtorzi |
| Other names | Toripalimab-tpzi |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a624004 |
| License data | |
| Routes of administration | Intravenous |
| Drug class | Antineoplastic |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6548H10104N1728O2054S44 |
| Molar mass | 147309.54 g·mol−1 |
Toripalimab, sold under the brand nameLoqtorzi, is amonoclonal antibody used for the treatment of melanoma and nasopharyngeal carcinoma.[3][7] Toripalimab is a recombinant humanizedprogrammed cell death protein 1 (PD-1)monoclonal antibody that acts as acheckpoint inhibitor.[8]
In 2018, toripalimab was approved in China for the treatment of unresectable or metastaticmelanoma that has failed previous systemic therapy.[8] In October 2023, the USFood and Drug Administration (FDA) approved toripalimab for the first-line treatment of adults with metastatic or recurrent, locally advancednasopharyngeal carcinoma when used withcisplatin andgemcitabine.[7][9]
Toripalimab isindicated in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advancednasopharyngeal carcinoma.[3][7] 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.[3][7]
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.[7] Participants were randomized (1:1) to either toripalimab with cisplatin and gemcitabine, followed by toripalimab, or placebo with cisplatin and gemcitabine, followed by placebo.[7]
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.[7] Participants received toripalimab until disease progression per RECIST v1.1 or unacceptable toxicity.[7]
The FDA granted the application for toripalimabpriority review,breakthrough therapy, andorphan drug designations.[7]
In July 2024, theCommittee for Medicinal Products for Human Use (CHMP) of theEuropean 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.[5] The applicant for this medicinal product is TMC Pharma (EU) Limited.[5] Loqtorzi was authorized for medical use in the European Union in September 2024.[5][6]
This article incorporates text from this source, which is in thepublic domain.
