Toripalimab (Loqtorzi)

Mechanism of action

From the NCI Drug Dictionary: A humanized immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed cell death 1 (programmed death-1; PD-1), with potential immune checkpoint inhibitory and antineoplastic activities. Upon administration, toripalimab binds to PD-1 and inhibits the binding of PD-1 to its ligands, programmed cell death-1 ligand 1 (PD-L1) and PD-1 ligand 2 (PD-L2). This prevents the activation of PD-1 and its downstream signaling pathways. This may restore immune function through the activation of both T cells and T-cell-mediated immune responses against tumor cells.

Diseases for which it is established

• Nasopharyngeal carcinoma

Diseases for which it is used

• Breast cancer, triple negative
• Clear cell renal cell carcinoma
• Esophageal squamous cell carcinoma
• Melanoma
• Non-small cell lung cancer, nonsquamous
• Non-small cell lung cancer, squamous
• Urothelial carcinoma

History of changes in FDA indication

• 2023-10-27: Approved with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma (NPC). (Based on JUPITER-02)
• 2023-10-27: Approved as a single agent for adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy. (Based on POLARIS-02)

History of changes in NMPA indication

• 2018-12-17: Initial approval
• 2024-04-11: Approved in combination with axitinib for the first-line treatment of patients with medium- to high-risk unresectable or metastatic renal cell carcinoma (RCC). (Based on RENOTORCH)

Also known as

• Code names: JS-001, TAB-001
• Generic name: teriprolizumab, toripalimab-tpzi
• Brand name: Loqtorzi, Tuoyi