SU11248 is a novel FLT3 tyrosine kinase inhibitor with potent activity in vitro and in vivo

Blood. 2003 May 1;101(9):3597-605. doi: 10.1182/blood-2002-07-2307. Epub 2003 Jan 16.

Abstract

FLT3 (fms-related tyrosine kinase/Flk2/Stk-2) is a receptor tyrosine kinase (RTK) primarily expressed on hematopoietic cells. In blasts from acute myelogenous leukemia (AML) patients, 2 classes of FLT3 activating mutations have been identified: internal tandem duplication (ITD) mutations in the juxtamembrane domain (25%-30% of patients) and point mutations in the kinase domain activation loop (7%-8% of patients). FLT3-ITD mutations are the most common molecular defect identified in AML and have been shown to be an independent prognostic factor for decreased survival. FLT3-ITD is therefore an attractive molecular target for therapy. SU11248 is a recently described selective inhibitor with selectivity for split kinase domain RTKs, including platelet-derived growth factor receptors, vascular endothelial growth factor receptors, and KIT. We show that SU11248 also has potent activity against wild-type FLT3 (FLT3-WT), FLT3-ITD, and FLT3 activation loop (FLT3-Asp835) mutants in phosphorylation assays. SU11248 inhibits FLT3-driven phosphorylation and induces apoptosis in vitro. In addition, SU11248 inhibits FLT3-induced VEGF production. The in vivo efficacy of SU11248 was investigated in 2 FLT3-ITD models: a subcutaneous tumor xenograft model and a bone marrow engraftment model. We show that SU11248 (20 mg/kg/d) dramatically regresses FLT3-ITD tumors in the subcutaneous tumor xenograft model and prolongs survival in the bone marrow engraftment model. Pharmacokinetic and pharmacodynamic analysis in subcutaneous tumors showed that a single administration of an efficacious drug dose potently inhibits FLT3-ITD phosphorylation for up to 16 hours following a single dose. These results suggest that further exploration of SU11248 activity in AML patients is warranted.

Publication types

  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Acute Disease
  • Amino Acid Substitution
  • Animals
  • Antineoplastic Agents / pharmacology*
  • Antineoplastic Agents / therapeutic use
  • Apoptosis / drug effects
  • Bone Marrow Transplantation
  • Endothelial Growth Factors / biosynthesis
  • Enzyme Inhibitors / pharmacology*
  • Enzyme Inhibitors / therapeutic use
  • Female
  • Humans
  • Indoles / pharmacology*
  • Indoles / therapeutic use
  • Intercellular Signaling Peptides and Proteins / biosynthesis
  • Leukemia, Myeloid / enzymology
  • Leukemia, Myeloid / pathology
  • Lymphokines / biosynthesis
  • Mice
  • Mice, Inbred NOD
  • Mice, Nude
  • Mice, SCID
  • Neoplasm Proteins / antagonists & inhibitors
  • Neoplasm Proteins / genetics
  • Phosphorylation / drug effects
  • Point Mutation
  • Protein Processing, Post-Translational / drug effects
  • Protein Structure, Tertiary
  • Proto-Oncogene Proteins / antagonists & inhibitors*
  • Proto-Oncogene Proteins / genetics
  • Pyrroles / pharmacology*
  • Pyrroles / therapeutic use
  • Receptor Protein-Tyrosine Kinases / antagonists & inhibitors*
  • Receptor Protein-Tyrosine Kinases / genetics
  • Recombinant Fusion Proteins / antagonists & inhibitors
  • Signal Transduction / drug effects
  • Sunitinib
  • Tandem Repeat Sequences
  • Transfection
  • Tumor Cells, Cultured / enzymology
  • Vascular Endothelial Growth Factor A
  • Vascular Endothelial Growth Factors
  • Xenograft Model Antitumor Assays
  • fms-Like Tyrosine Kinase 3

Substances

  • Antineoplastic Agents
  • Endothelial Growth Factors
  • Enzyme Inhibitors
  • Indoles
  • Intercellular Signaling Peptides and Proteins
  • Lymphokines
  • Neoplasm Proteins
  • Proto-Oncogene Proteins
  • Pyrroles
  • Recombinant Fusion Proteins
  • Vascular Endothelial Growth Factor A
  • Vascular Endothelial Growth Factors
  • FLT3 protein, human
  • Flt3 protein, mouse
  • Receptor Protein-Tyrosine Kinases
  • fms-Like Tyrosine Kinase 3
  • Sunitinib