Drug intelligence / Profile preview

levofolinic acid + 5-fluorouracil + irinotecan liposome + cetuximab + bevacizumab

Development stage
Unknown
Lead developer
The First Hospital of Jilin University
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
Administration
Intravenous
01

Overview

This experimental combination regimen is being evaluated as a second-line therapy for patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC). The regimen consists of a cytotoxic backbone comprising liposomal irinotecan (a topoisomerase I inhibitor encapsulated in a lipid bilayer), 5-fluorouracil (an antimetabolite), and levofolinic acid (a folate analog that enhances the binding of 5-FU to its target). Additionally, the regimen incorporates targeted monoclonal antibodies: cetuximab, which targets the epidermal growth factor receptor (EGFR), and bevacizumab, which targets vascular endothelial growth factor (VEGF). In clinical trial settings, such as the Phase 2 study led by The First Hospital of Jilin University (NCT05643612), the targeted agents are typically administered based on physician choice (either cetuximab or bevacizumab) rather than concurrently, although the regimen name encompasses the full scope of the study's experimental arms. The combination aims to overcome resistance in patients who have progressed on or are intolerant to first-line oxaliplatin-based therapies.

Brand names
Onivyde
Other names
Levoleucovorin/5-FU + Liposomal Irinotecan ± Cetuximab/BevacizumabLevofolinic Acid + 5-FU continuous infusion + irinotecan HCl liposome ± cetuximab/bevacizumab
02

Targets

EGFR T790M (Epidermal growth factor receptor T790M mutant)TS (Thymidylate synthase)VEGFA (Vascular endothelial growth factor A)TOP1 (DNA Topoisomerase I)DNA

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