Business
Syndax Announces Data from Pivotal AUGMENT-101 Trial of Revumenib in Relapsed/Refractory KMT2Ar Acute Leukemia Selected as Late-Breaking Presentation at the 65th ASH Annual Meeting
WALTHAM, Mass., Nov. 21, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative
About this update from Syndax Pharmaceuticals, Inc.
[{"type":"text","content":"WALTHAM, Mass., Nov. 21, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that data from the pivotal trial of revumenib, the Company's highly selective, oral menin inhibitor, will be featured in a late-breaking presentation at the 65th American Society of Hematology (ASH) Annual Meeting being held December 9-12, 2023 in San Diego, California. A copy of the abstract is now available online via the ASH website at www.hematology.org.\n\n\"We are pleased the ASH program committee recognized AUGMENT-101 as a substantive study of high impact and selected it as a late-breaker presentation this year,\" said Michael A. Metzger, Chief Executive Officer. \"We believe the AUGMENT-101 results continue to underscore revumenib's potential as a first- and best-in-class treatment option for patients with KMT2Ar and mNPM1 acute leukemias. We are excited to showcase revumenib's clinical profile both as a monotherapy and in combination at ASH ahead of a potential first FDA approval of revumenib in mid-2024.\"\nDetails of the presentation are as follows:\nAbstract Number: LBA-5Title: Revumenib Monotherapy in Patients with Relapsed/Refractory KMT2Ar Acute Leukemia: Topline Efficacy and Safety Results from the Pivotal AUGMENT-101 Phase 2 StudyPresenter: Ibrahim Aldoss, M.D.Session Name: Late-Breaking Abstracts SessionSession Date: Tuesday, December 12, 2023Session Time: 9:00 – 10:30 a.m. PTPresentation Time: 10:00 a.m. PT\nAbout the Pivotal Phase 2 Portion of the AUGMENT-101 Trial:\nAUGMENT-101 is a Phase 1/2 open-label trial designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of orally administered revumenib. The Company previously announced positive topline data from the protocol-defined pooled analysis of the pivotal Phase 2 portion of the AUGMENT-101 trial in patients with relapsed/refractory (R/R) KMT2A-rearranged (KMT2Ar) acute leukemia. The trial met its primary endpoint with a complete remission (CR) or a CR with partial hematological recovery (CRh) rate of 23% at the interim analysis of the pooled KMT2Ar acute myeloid leukemia and acute lymphoid leukemia cohorts (p-value = 0.0036). Based on the Independent Data Monitoring Committee recommendation, the Company stopped the trial to further accrua...