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Association details:
| Biomarker: | NPM1 mutation |
|---|---|
| Cancer: | Leukemia |
| Drug: | revumenib (SNDX-5613) (Menin-MLL inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Testing the Addition of an Anti-cancer Drug, SNDX-5613, to the Standard Chemotherapy Treatment (Daunorubicin and Cytarabine) for Newly Diagnosed Patients With Acute Myeloid Leukemia That Has Changes in NPM1 or MLL/KMT2A Gene
Excerpt:
...Patients ages 18-75 years at time of diagnosis with NPM1-mutated/FLT3-ITD wildtype and NPM1-mutated/FLT3-TKD wildtype or MLL (KMT2A) rearranged untreated AML and who are candidates for intensive induction chemotherapy...
Trial ID:
Source:
Title:
Expanded Access Program for SNDX-5613
Excerpt:
...- Diagnosed with relapsed/refractory acute leukemia harboring a mixed lineage leukemia rearrangement, nucleoporin 98 rearrangement, nucleophosmin 1 mutation (or mutated) mutation or any other genetic alteration with overexpression of HOXA genes predicted to potentially respond to menin inhibitors....
Trial ID:
More C2 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:
AMLM26/T4 INTERCEPT: A multi-arm trial for patients with acute myeloid leukaemia investigating new treatments which target early relapse and changes in disease characteristics - SNDX5613
Excerpt:
...Presence of MLL-r or PTD, or NPM1 mutation in a bone marrow or peripheral blood sample taken no more than 28 days prior to cycle 1 of day 1 of treatment on this treatment arm. ...
Trial ID:
Less C2 evidence
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:
