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Leuk Res Rep. 2014 Jul 5;3(2):58-61. doi: 10.1016/j.lrr.2014.06.003. eCollection 2014.

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

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John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, NJ, USA.
Service d׳hématologie Clinique, Hôpital Avicenne (AP-HP)/Université, Paris 13, Bobigny, France.
Mary Babb Randolph Cancer Center, West Virginia University School of Medicine, Morgantown, WV, USA.
Service d׳hématologie et Thérapie Cellulaire, CNRS UMR 7292, CHRU de Tours, France.
Division of Hematology and Cellular Therapy, Western Pennsylvania Cancer Institute, Pittsburgh, PA, USA.
Hôpital Maisonneuve-Rosemont, Montreal, QC, Canada.
Service d׳hématologie CHU Bordeaux, Pessac, France.
David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA.
Takeda Pharmaceuticals International Co., Cambridge, MA, USA.
Division of Oncology, Washington University Medical School, St. Louis, MO, USA.


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.


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

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