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Association details:
| Biomarker: | MLL rearrangement |
|---|---|
| Cancer: | Leukemia |
| Drug: | revumenib (SNDX-5613) (Menin-MLL inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A Study of SNDX-5613 in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation
Excerpt:
...Participants must have active acute leukemia (bone marrow blasts ≥5% or reappearance of blasts in peripheral blood) as defined by the National Comprehensive Cancer Network (NCCN) in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Lymphoblastic Leukemia (Version 1.2020) and Acute Myeloid Leukemia (Version 3.2020), or acute leukemia harboring an MLL rearrangement, NUP98 rearrangement, or NPM1c mutation that have detectable disease in the bone marrow....
Trial ID:
Source:
Title:
Safety and Efficacy of Menin Inhibition in Patients (Pts) with MLL-Rearranged and NPM1 Mutant Acute Leukemia: A Phase (Ph) 1, First-in-Human Study of SNDX-5613 (AUGMENT 101)
Published date:
12/24/2021
Excerpt:
SNDX-5613 (5613) is a potent, selective protein-protein interaction inhibitor of menin being evaluated in the AUGMENT-101 study, a first-in-human (FIH), Ph 1/2 study in pts with R/R acute leukemia. Here, we report the results of the completed, Ph 1 component....The study includes 2 parallel dose-escalation cohorts: pts not taking (Arm A) or taking (Arm B) strong CYP3A4 inhibitors....The composite CR (CRc: CR+CRh+CRp+CRi/MLFS) rate was 44% (20/45 pts) (Table 3). Among pts with MLLr leukemia, the CRc rate was 49% (17/35 pts) and in pts with mNPM1 leukemia, the CRc rate was 30% (3/10 pts); 14/20 (70%) pts with CRc achieved MRD negativity assessed locally by flow cytometry or PCR...In this FIH Ph 1 study, SNDX-5613 demonstrates an acceptable safety profile and promising antileukemic activity in pts with heavily pretreated R/R MLLr and mNPM1 acute leukemia.
DOI:
10.1182/blood-2021-146944
Trial ID:
