Proapoptotic and immunomodulatory effects of SYK inhibitor entospletinib in combination with obinutuzumab in patients with chronic lymphocytic leukaemia

Br J Clin Pharmacol. 2022 Feb;88(2):836-841. doi: 10.1111/bcp.14962. Epub 2021 Jul 19.

Abstract

Spleen tyrosine kinase (SYK) is indispensable in B-cell receptor signalling. SYK inhibitor entospletinib demonstrated clinical efficacy in patients with chronic lymphocytic leukaemia (CLL). However, pharmacodynamic effects of SYK inhibition in CLL cells and immunomodulatory effects of B-cell receptor-signalling inhibitors in patients with CLL are poorly understood. We conducted a phase 2 trial of entospletinib in combination with obinutuzumab, an anti-CD20 antibody, in 17 patients with relapsed/refractory CLL. Pharmacodynamic analysis demonstrated that treatment with entospletinib led to rapid downmodulation of pSTAT3 and the anti-apoptotic protein MCL1 in CLL cells. Meanwhile, 6 months of combination therapy was accompanied by a reduction in interferon-γ secretion in CD4+ T-cells and a reversal of exhausted phenotype, as evidenced by downregulation of PD-1. Thus, SYK inhibition downmodulates MCL-1 and partially restores T-cell immunity in CLL. Trial registration number NCT03010358.

Keywords: MCL1; PD-1; chronic lymphocytic leukaemia; spleen tyrosine kinase.

Publication types

  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibodies, Monoclonal, Humanized
  • Humans
  • Indazoles
  • Leukemia, Lymphocytic, Chronic, B-Cell* / drug therapy
  • Neoplasm Recurrence, Local
  • Pyrazines
  • Receptors, Antigen, B-Cell / therapeutic use
  • Syk Kinase / antagonists & inhibitors
  • Syk Kinase / therapeutic use

Substances

  • 6-(1H-indazol-6-yl)-N-(4-morpholinophenyl)imidazo(1,2-a)pyrazin-8-amine
  • Antibodies, Monoclonal, Humanized
  • Indazoles
  • Pyrazines
  • Receptors, Antigen, B-Cell
  • SYK protein, human
  • Syk Kinase
  • obinutuzumab

Associated data

  • ClinicalTrials.gov/NCT03010358