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Association details:
| Biomarker: | KMT2A rearrangement |
|---|---|
| Cancer: | Acute Myelogenous Leukemia |
| Drug: | revumenib (SNDX-5613) (Menin-MLL inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Syndax Announces FDA Priority Review of NDA for Revumenib for the Treatment of Relapsed/Refractory KMT2Ar Acute Leukemia
Published date:
03/26/2024
Excerpt:
...the U.S. Food and Drug Administration (FDA) has granted Priority Review for its New Drug Application (NDA) for revumenib, the Company's first-in-class menin inhibitor, for the treatment of adult and pediatric relapsed or refractory (R/R) KMT2A-rearranged (KMT2Ar) acute leukemia...revumenib in adult and pediatric patients with KMT2Ar acute myeloid leukemia (AML) and acute lymphoid leukemia (ALL).
Source:
Title:
Syndax Announces U.S. FDA Breakthrough Therapy Designation Granted for Revumenib for the Treatment of Adult and Pediatric Patients with Relapsed or Refractory KMT2A- Rearranged (MLLr) Acute Leukemia
Published date:
12/05/2022
Excerpt:
Syndax Pharmaceuticals...today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for revumenib for the treatment of adult and pediatric patients with relapsed or refractory (R/R) acute leukemia harboring a KMT2A rearrangement (KMT2Ar)....The BTD is supported by Phase 1 data from the AUGMENT-101 trial.
Source:
Title:
A Study of SNDX-5613 in Combination With Chemotherapy in Participants With R/R Acute Leukemia
Excerpt:
...- Participants must have documented relapsed or refractory (R/R) AML, ALL, or acute leukemias of ambiguous lineage (ALAL) including MPAL and acute undifferentiated leukemia (AUL) harboring KMT2A rearrangement, KMT2A amplification, NPM1c, or NUP98r....
Trial ID:
Source:
Title:
2907 Revumenib Monotherapy in Patients with Relapsed/Refractory KMT2Ar Acute Leukemias: Efficacy and Safety Results from the Augment-101 Phase 1/2 Study
Published date:
11/02/2023
Excerpt:
In adults with AML (n=51), the largest KMT2Ar subgroup, CR+CRh was 28% and overall response rate (ORR) was 59%. Responses were consistent in ALL/other leukemia subtype (n=15), with 27% CR+CRh and 53% ORR. ORR (61%) was similar in pediatric pts (<18 years, n=18)...These phase 1 data continue to demonstrate deep responses to revumenib and a manageable safety profile in heavily pretreated patients with R/R KMT2Ar acute leukemia across ages and subtypes.
Source:
Title:
Syndax Announces Pivotal AUGMENT-101 Trial of Revumenib in Relapsed/Refractory KMT2Ar Acute Leukemia Meets Primary Endpoint and Stopped Early for Efficacy Following Protocol-Defined Interim Analysis
Published date:
10/02/2023
Excerpt:
Syndax Pharmaceuticals...announced positive topline data from the protocol-defined pooled analysis of the pivotal AUGMENT-101 trial of revumenib, a first-in-class menin inhibitor, in adult and pediatric patients with relapsed/refractory (R/R) KMT2A-rearranged (KMT2Ar) acute myeloid leukemia (AML) and acute lymphoid leukemia (ALL)...The AUGMENT-101 trial met its primary endpoint at the protocol-defined interim analysis stage with a complete remission (CR) or a CR with partial hematological recovery (CRh) rate of 23% (13/57; 95% confidence interval [CI]: [12.7, 35.8, one-sided p-value = 0.0036]) among the 57 efficacy evaluable patients in the pooled KMT2Ar acute leukemia cohort. The CR/CRh rate in patients with KMT2Ar AML was 24.5% (12/49).
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:
