Synergistic activity of IDH1 inhibitor BAY1436032 with azacitidine in IDH1 mutant acute myeloid leukemia

Haematologica. 2021 Feb 1;106(2):565-573. doi: 10.3324/haematol.2019.236992.

Abstract

Mutant IDH1 (mIDH1) inhibitors have shown single-agent activity in relapsed/refractory AML, though most patients eventually relapse. We evaluated the efficacy and molecular mechanism of the combination treatment with azacitidine, which is currently the standard of care in older AML patients, and mIDH1 inhibitor BAY1436032. Both compounds were evaluated in vivo as single agents and in combination with sequential (azacitidine, followed by BAY1436032) or simultaneous application in two human IDH1 mutated AML xenograft models. Combination treatment significantly prolonged survival compared to single agent or control treatment (P<.005). The sequential combination treatment depleted leukemia stem cells (LSC) by 470-fold. Interestingly, the simultaneous combination treatment depleted LSCs by 33,150-fold compared to control mice. This strong synergy is mediated through inhibition of MAPK/ERK and RB/E2F signaling. Our data strongly argues for the concurrent application of mIDH1 inhibitors and azacitidine and predicts improved outcome of this regimen in IDH1 mutated AML patients.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aniline Compounds
  • Animals
  • Azacitidine*
  • Benzimidazoles
  • Humans
  • Isocitrate Dehydrogenase / genetics
  • Leukemia, Myeloid, Acute* / drug therapy
  • Leukemia, Myeloid, Acute* / genetics
  • Mice

Substances

  • Aniline Compounds
  • BAY 1436032
  • Benzimidazoles
  • Isocitrate Dehydrogenase
  • IDH1 protein, human
  • Azacitidine

Grants and funding

FinanzierungThis work was supported by funding from Bayer AG, an ERC grant under the European Union’s Horizon 2020 research and innovation programme (No. 638035), by grant 70112697 from Deutsche Krebshilfe; the German Federal Ministry of Education and Research grant 01EO0802 (IFB-Tx); and DFG grants HE 5240/5-1, HE 5240/6-1 and HE5240/6-2.