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]
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]
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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