Drug intelligence / Profile preview

donafenib + fluorouracil + leucovorin + oxaliplatin + toripalimab

Development stage
Unknown
Lead developer
Li Ning
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
Administration
Intravenous, Oral, Intra-arterial
01

Overview

This combination therapy regimen is being investigated as a conversion therapy for patients with unresectable hepatocellular carcinoma (HCC). It consists of the PD-1 immune checkpoint inhibitor toripalimab, the multikinase inhibitor donafenib, and hepatic arterial infusion chemotherapy (HAIC) using the FOLFOX regimen (oxaliplatin, leucovorin, and fluorouracil). Toripalimab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands (PD-L1 and PD-L2), thereby restoring the anti-tumor activity of T-cells. Donafenib is a small molecule multikinase inhibitor that targets vascular endothelial growth factor receptors (VEGFR), platelet-derived growth factor receptors (PDGFR), and the RAF/MEK/ERK signaling pathway to inhibit tumor angiogenesis and proliferation. The FOLFOX component provides cytotoxic chemotherapy directly to the liver via the hepatic artery, aiming to shrink tumors to a resectable size. This multi-modal approach is currently being evaluated in Phase II clinical trials led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.

Brand names
TuoyiZuniduo
Other names
HAIC + Donafenib + ToripalimabFOLFOX + Donafenib + ToripalimabHAIC(FOLFOX) + Donafenib + Toripalimab
02

Targets

PDCD1 (Programmed cell death protein 1 receptor)TS (Thymidylate synthase)VEGFR (VEGFR family)PDGFRB (Platelet-derived growth factor receptor beta)DNARAF1 (c-Raf-1 (Y340D/Y341D))

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