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ASH 2021 | Phase I/II study of novel FLT3 inhibitor HM43239 in R/R AML

Naval Daver, MD, University of Texas MD Anderson Cancer Center, Houston, TX, gives an overview of the results of a Phase I/II dose-escalation and expansion first-in-human study evaluating HM43239, a novel multi-kinase inhibitor, in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) (NCT03850574). In pre-clinical studies, HM43239 was shown to be highly active against FLT3-ITD mutations and inhibited the phosphorylation of SYK, a tyrosine kinase associated with resistance to FLT3-targeted therapy. This trial reported a favorable safety profile for HM43239, with mild adverse events including diarrhea, nausea, and vomiting. In addition, there were no dose-limiting toxicities. HM43239 was shown to be active in both FLT3-positive and FLT3 wild-type AML at 80 mg. The trial is currently evaluating doses above 80 mg to determine the recommended Phase II Dose (RP2D). This interview took place at the 63rd ASH Annual Meeting and Exposition congress in Atlanta, GA.