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Revumenib with azacitidine + venetoclax in ND NPM1m or KMT2Ar AML
Results from the phase I dose-escalation and expansion substudy (BAML-16-001-S17) of the Beat AML master protocol (NCT03013998) evaluating the triplet combination of revumenib with azacitidine and venetoclax in newly diagnosed (ND) older adults with NPM1-mutated (NPM1m) or KMT2A-rearranged (KMT2Ar) acute myeloid leukemia (AML), were recently published in the Journal of Clinical Oncology by Zeidner et al.
Key data: The overall response rate (ORR) was 88.4% (95% CI, 74.9–96.1) and the composite complete remission (CRc) rate was 81.4% (95% CI, 66.6–91.6) in 43 enrolled patients aged ≥60 years; all 37 evaluable patients achieved measurable residual disease (MRD) negativity. The regimen was well tolerated with no maximum tolerated dose (MTD) determined and manageable rates of differentiation syndrome (19%) and QTc prolongation (44%).
Key learning: Revumenib + azacitidine + venetoclax combination therapy offers a promising, targeted treatment approach for older adults with ND NPM1m or KMT2Ar AML, demonstrating favorable response rates and achieving universal MRD negativity while maintaining a favorable safety profile. Data support further investigation of this novel triplet regimen.
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