Drug intelligence / Profile preview

toripalimab + lenvatinib + gemcitabine + oxaliplatin

Development stage
Phase 3
Lead developer
Junshi Biosciences
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
Administration
Intravenous, Oral
01

Overview

This combination therapy consists of toripalimab (JS001), an anti-PD-1 monoclonal antibody; lenvatinib, a multi-kinase inhibitor; and the GEMOX chemotherapy regimen (gemcitabine and oxaliplatin). It is being investigated primarily for the treatment of advanced and unresectable intrahepatic cholangiocarcinoma (iCCA). Toripalimab works by blocking the PD-1 receptor on T-cells, enhancing the immune response against tumor cells. Lenvatinib inhibits multiple receptor tyrosine kinases, including VEGFR, FGFR, and PDGFR, to inhibit angiogenesis and tumor growth. Gemcitabine and oxaliplatin are cytotoxic agents that interfere with DNA synthesis and cause DNA damage, respectively. A Phase 2 study conducted at Shanghai Zhongshan Hospital (NCT03951597) demonstrated significant efficacy in patients with advanced iCCA, showing an objective response rate of 80%.

Brand names
Tuoyi
Other names
toripalimab + lenvatinib + GEMOXJS001 + lenvatinib + gemcitabine + oxaliplatin
02

Targets

DNAFGFR1 (Fibroblast growth factor receptor 1)FGFR2 (Keratinocyte growth factor receptor)FGFR3 (Fibroblast growth factor receptor 3)FGFR4 (Fibroblast growth factor receptor 4)KIT (c-KIT proto-oncogene receptor tyrosine kinase)PDCD1 (Programmed cell death protein 1 receptor)PDGFRA (Platelet-derived growth factor receptor alpha)RET (Rearranged during transfection receptor tyrosine kinase)VEGFR-1 (Vascular endothelial growth factor receptor 1)VEGFR2 (Vascular endothelial growth factor receptor 2)VEGFR4 (Vascular endothelial growth factor Receptor-3)

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