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The trial that turned menin inhibition from an idea into the first approved drug for KMT2A-rearranged leukaemia.
KMT2Ar cohort (n=57 efficacy population): CR+CRh 22.8%, ORR 63.2%, most CR/CRh MRD-negative; median OS ~8 months. JCO 2024. Led to November 2024 approval in KMT2Ar acute leukaemia (adults and children ≥1 year) and, with the NPM1 cohort, to the October 2025 NPM1 approval. Differentiation syndrome and QT prolongation were the key toxicities; MEN1 resistance mutations emerged in about a third of relapsing patients.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
Shares Menin inhibitors for infant KMT2A-rearranged ALL, Differentiation syndrome, NPM1 mutation, AUGMENT-101: revumenib, the first menin inhibitor, in relapsed leukaemias driven by KMT2A rearrangement or NPM1 mutation.
Shares NPM1 mutation, AUGMENT-101: revumenib, the first menin inhibitor, in relapsed leukaemias driven by KMT2A rearrangement or NPM1 mutation, KMT2A (MLL) rearrangement, Revumenib.
Shares NPM1 mutation, KMT2A (MLL) rearrangement, Revumenib, NPM1-mutated and KMT2A-rearranged acute myeloid leukaemia.
Shares NPM1 mutation, KMT2A (MLL) rearrangement, Revumenib, NPM1-mutated and KMT2A-rearranged acute myeloid leukaemia.
Shares Revumenib, NPM1-mutated and KMT2A-rearranged acute myeloid leukaemia, Menin, Infant acute lymphoblastic leukaemia (KMT2A-rearranged, under one year).
Shares NPM1 mutation, NPM1-mutated and KMT2A-rearranged acute myeloid leukaemia, Menin, Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome.
Shares Revumenib, NPM1-mutated and KMT2A-rearranged acute myeloid leukaemia, Menin, Infant acute lymphoblastic leukaemia (KMT2A-rearranged, under one year).
Shares Syndax Pharmaceuticals, Revumenib, Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET), Acute myeloid leukaemia.
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/