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.

• Authors: Stuart L Goldberg, Pierre Fenaux, Michael D Craig, Emmanuel Gyan, John Lister, Jeannine Kassis, Arnaud Pigneux, Gary J Schiller, JungAh Jung, E Jane Leonard, Howard Fingert, Peter Westervelt
• Journal: Leukemia research reports (Leuk Res Rep) Vol. 3 Issue 2 Pg. 58-61 ( 2014) ISSN: 2213-0489 [Print] England
• PMID: 25068104 (Publication Type: Journal Article)