Dr. Wang on Preliminary Findings From the KOMET-001 Trial in Relapsed/Refractory AML

Eunice Wang, MD, chief, Leukemia Service, Roswell Park Comprehensive Cancer Center, discusses preliminary findings from the ongoing KOMET-001 trial (NCT04067336) in relapsed/refractory acute myeloid leukemia (AML).

The first-in-human, open-label, phase 1/2a study is evaluating the oral, selective menin inhibitor KO-539. Currently, the study has enrolled 12 patients to 1 of 4 dosing cohorts. At the data cutoff, 1 patient was enrolled to the 50 mg cohort, 1 patient was enrolled to the 100 mg cohort, 6 were enrolled to the 200 mg cohort, and 4 were enrolled to the 400 mg cohort, Wang says. 

Notably, preliminary findings showed that all adverse effects (AEs) observed were mild, reversible, and did not result in treatment discontinuation. Grade 3 or higher AEs​, reported in 1 patient each, included pancreatitis, increased lipase, decreased neutrophil count, tumor lysis syndrome, and deep vein thrombosis. Grade 1 or 2 AEs included nausea,, rash, and diarrhea. No AEs common with other drugs in this category, such as QT prolongation, were observed. Additionally, no drug-drug interactions or limitations with coadministration of CYP3A4 inhibitors were noted, Wang concludes.