ARN-509: a novel antiandrogen for prostate cancer treatment

Cancer Res. 2012 Mar 15;72(6):1494-503. doi: 10.1158/0008-5472.CAN-11-3948. Epub 2012 Jan 20.

Abstract

Continued reliance on the androgen receptor (AR) is now understood as a core mechanism in castration-resistant prostate cancer (CRPC), the most advanced form of this disease. While established and novel AR pathway-targeting agents display clinical efficacy in metastatic CRPC, dose-limiting side effects remain problematic for all current agents. In this study, we report the discovery and development of ARN-509, a competitive AR inhibitor that is fully antagonistic to AR overexpression, a common and important feature of CRPC. ARN-509 was optimized for inhibition of AR transcriptional activity and prostate cancer cell proliferation, pharmacokinetics, and in vivo efficacy. In contrast to bicalutamide, ARN-509 lacked significant agonist activity in preclinical models of CRPC. Moreover, ARN-509 lacked inducing activity for AR nuclear localization or DNA binding. In a clinically valid murine xenograft model of human CRPC, ARN-509 showed greater efficacy than MDV3100. Maximal therapeutic response in this model was achieved at 30 mg/kg/d of ARN-509, whereas the same response required 100 mg/kg/d of MDV3100 and higher steady-state plasma concentrations. Thus, ARN-509 exhibits characteristics predicting a higher therapeutic index with a greater potential to reach maximally efficacious doses in man than current AR antagonists. Our findings offer preclinical proof of principle for ARN-509 as a promising therapeutic in both castration-sensitive and castration-resistant forms of prostate cancer.

Publication types

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

MeSH terms

  • Androgen Antagonists / pharmacokinetics
  • Androgen Antagonists / therapeutic use*
  • Anilides / pharmacokinetics
  • Anilides / therapeutic use
  • Animals
  • Antineoplastic Agents, Hormonal / blood
  • Antineoplastic Agents, Hormonal / pharmacokinetics
  • Antineoplastic Agents, Hormonal / therapeutic use*
  • Benzamides
  • Cell Line, Tumor
  • Cell Proliferation / drug effects
  • Gene Expression Regulation, Neoplastic / drug effects
  • Humans
  • Male
  • Mice
  • Nitriles / pharmacokinetics
  • Nitriles / therapeutic use
  • Phenylthiohydantoin / analogs & derivatives
  • Phenylthiohydantoin / blood
  • Phenylthiohydantoin / pharmacokinetics
  • Phenylthiohydantoin / therapeutic use
  • Prostatic Neoplasms / drug therapy*
  • Rats
  • Receptors, Androgen / drug effects
  • Thiohydantoins / blood
  • Thiohydantoins / chemical synthesis
  • Thiohydantoins / pharmacokinetics
  • Thiohydantoins / therapeutic use*
  • Tosyl Compounds / pharmacokinetics
  • Tosyl Compounds / therapeutic use
  • Xenograft Model Antitumor Assays

Substances

  • AR protein, human
  • Androgen Antagonists
  • Anilides
  • Antineoplastic Agents, Hormonal
  • Benzamides
  • Nitriles
  • Receptors, Androgen
  • Thiohydantoins
  • Tosyl Compounds
  • apalutamide
  • Phenylthiohydantoin
  • enzalutamide
  • bicalutamide