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

doi:10.1016/j.lrr.2014.06.003

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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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 language	English
Pages (from-to)	58-61
Number of pages	4
Journal	Leukemia Research Reports
Volume	3
Issue number	2
DOIs	https://doi.org/10.1016/j.lrr.2014.06.003
State	Published - 2014

Keywords

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

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10.1016/j.lrr.2014.06.003

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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

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

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.",

keywords = "Acute myeloid leukemia (AML), Alisertib, Aurora A kinase inhibitor, Myelodysplastic syndrome (MDS), Safety",

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

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year = "2014",

doi = "10.1016/j.lrr.2014.06.003",

language = "English",

volume = "3",

pages = "58--61",

journal = "Leukemia Research Reports",

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Goldberg, SL, Fenaux, P, Craig, MD, Gyan, E, Lister, J, Kassis, J, Pigneux, A, Schiller, GJ, Jung, JA, 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, vol. 3, no. 2, pp. 58-61. https://doi.org/10.1016/j.lrr.2014.06.003

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AU - Goldberg, Stuart L.

AU - Fenaux, Pierre

AU - Craig, Michael D.

AU - Gyan, Emmanuel

AU - Lister, John

AU - Kassis, Jeannine

AU - Pigneux, Arnaud

AU - Schiller, Gary J.

AU - Jung, Jung Ah

AU - Jane Leonard, E.

AU - Fingert, Howard

AU - Westervelt, Peter

PY - 2014

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AB - 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.

KW - Acute myeloid leukemia (AML)

KW - Alisertib

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KW - Myelodysplastic syndrome (MDS)

KW - Safety

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

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