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Association details:
| Biomarker: | NPM1 mutation |
|---|---|
| Cancer: | Acute Myelogenous Leukemia |
| Drug: | revumenib (SNDX-5613) (Menin-MLL inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
SNDX-5613 Granted FDA Fast Track Designation for the Treatment of Relapsed/Refractory Acute Leukemias
Published date:
06/28/2021
Excerpt:
Syndax Pharmaceuticals, Inc...today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to SNDX-5613 for the treatment of adult and pediatric patients with relapsed or refractory acute leukemias harboring a mixed lineage leukemia rearranged (MLLr) or nucleophosmin (NPM1) mutation.
Source:
Title:
A study to investigation the short- and long-term safety and tolerability of the drug SNDX-5613 in Patients with Relapsed/Refractory Leukemias. Various doses of SNDX-5613 will be investigated.
Excerpt:
...Patients in Arms A and B must have active acute leukemia harboring mixed lineage leukemia (MLL) rearrangement or NPM1c mutation as defined by the National Comprehensive Cancer Network (NCCN) in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®) for Acute Lymphoblastic Leukemia (Ver 1.2020) and Acute Myeloid Leukemia (Ver 3.2020). ...
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:
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:
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:
Less C2 evidence
Source:
Title:
63 The Menin Inhibitor SNDX-5613 (revumenib) Leads to Durable Responses in Patients (Pts) with KMT2A-Rearranged or NPM1 Mutant AML: Updated Results of a Phase (Ph) 1 Study
Published date:
11/03/2022
Excerpt:
SNDX-5613 was administered orally, Q12h, in 28-day cycles….Pts with KMT2Ar or mNPM1 had an ORR of 59% (27/46 pts) and 36% (5/14 pts), respectively.
DOI:
https://doi.org/10.1182/blood-2022-164849
Trial ID:
Source:
Title:
Syndax Announces Positive Interim Data Demonstrating Robust Clinical Activity in Phase 1 Portion of the AUGMENT-101 Trial of SNDX-5613 in Patients with Genetically-Defined Acute Leukemias
Published date:
04/20/2021
Excerpt:
Syndax Pharmaceuticals, Inc...today announced updated positive data from the Phase 1 dose escalation portion of the ongoing Phase 1/2 AUGMENT-101 trial of SNDX-5613 in patients with mixed lineage leukemia rearranged (MLLr) and nucleophosmin (NPM1c) mutant relapsed/refractory (R/R) acute leukemias...The ORR in evaluable patients harboring an MLL-rearrangement (n=24), was 54% (n=13), and in evaluable patients harboring an NPM1c mutation (n=7), was 29% (n=2).
Trial ID:
Source:
Title:
Syndax Pharmaceuticals Announces Preclinical Profile and Initial Phase 1 Data Demonstrating Clinical Activity of Menin Inhibitor SNDX-5613 in Adults with Relapsed/Refractory Acute Leukemias
Published date:
04/27/2020
Excerpt:
Menin-MLL interaction inhibitors have also demonstrated robust treatment benefit in multiple preclinical models of NPM1 mutant AML, which represents the most frequent genetic abnormality in adult AML.
