On November 21, 2023 Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported 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) (Free ASH Whitepaper) Annual Meeting being held December 9-12, 2023 in San Diego, California (Press release, Syndax, NOV 21, 2023, View Source [SID1234637908]). A copy of the abstract is now available online via the ASH (Free ASH Whitepaper) website at www.hematology.org.
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"We are pleased the ASH (Free ASH Whitepaper) 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 (Free ASH Whitepaper) ahead of a potential first FDA approval of revumenib in mid-2024."
Details of the presentation are as follows:
Abstract Number: LBA-5
Title: Revumenib Monotherapy in Patients with Relapsed/Refractory KMT2Ar Acute Leukemia: Topline Efficacy and Safety Results from the Pivotal AUGMENT-101 Phase 2 Study
Presenter: Ibrahim Aldoss, M.D.
Session Name: Late-Breaking Abstracts Session
Session Date: Tuesday, December 12, 2023
Session Time: 9:00 – 10:30 a.m. PT
Presentation Time: 10:00 a.m. PT
About the Pivotal Phase 2 Portion of the AUGMENT-101 Trial:
AUGMENT-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 accrual in the KMT2Ar cohorts. Syndax has initiated the NDA submission for revumenib for the treatment of R/R KMT2Ar acute leukemia in adult and pediatric patients under the FDA’s Real-time Oncology Review (RTOR) program and expects to complete the NDA submission by year-end 2023.