An exploratory phase 2 study of investigational Aurora A kinase inhibitor alisertib (MLN8237) in acute myelogenous leukemia and myelodysplastic syndromes

Stuart L. Goldberg, Pierre Fenaux, Michael D. Craig, Emmanuel Gyan, John Lister, Jeannine Kassis, Arnaud Pigneux, Gary J. Schiller, Jung Ah Jung, E. Jane Leonard, Howard Fingert, Peter Westervelt

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57 Scopus citations

Abstract

Alisertib (MLN8237) is an investigational, oral, selective, Aurora A kinase (AAK) inhibitor. In this phase 2 trial, 57 patients with acute myeloid leukemia (AML) or high-grade myelodysplastic syndrome received alisertib 50. mg BID for 7 days in 21-day cycles. Responses in 6/35 AML patients (17% response rate with an additional 49% stable disease, 34% transfusion independence) included 1 complete response lasting >1 year. No responses were observed in MDS patients. Adverse events >30% included diarrhea, fatigue, nausea, febrile neutropenia, and stomatitis. Results suggest modest activity in AML, supporting further research to better understand how AAK inhibition may induce leukemic cell senescence.

Original languageEnglish
Pages (from-to)58-61
Number of pages4
JournalLeukemia Research Reports
Volume3
Issue number2
DOIs
StatePublished - Jan 1 2014

Keywords

  • Acute myeloid leukemia (AML)
  • Alisertib
  • Aurora A kinase inhibitor
  • Myelodysplastic syndrome (MDS)
  • Safety

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    Goldberg, S. L., Fenaux, P., Craig, M. D., Gyan, E., Lister, J., Kassis, J., Pigneux, A., Schiller, G. J., Jung, J. A., Jane Leonard, E., Fingert, H., & Westervelt, P. (2014). An exploratory phase 2 study of investigational Aurora A kinase inhibitor alisertib (MLN8237) in acute myelogenous leukemia and myelodysplastic syndromes. Leukemia Research Reports, 3(2), 58-61. https://doi.org/10.1016/j.lrr.2014.06.003