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.
"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."
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.
About Syndax
Syndax Pharmaceuticals is a clinical stage
biopharmaceutical company developing an innovative pipeline of
cancer therapies. Highlights of the Company's pipeline include
revumenib, a highly selective inhibitor of the menin–KMT2A binding
interaction, and axatilimab, a monoclonal antibody that blocks the
colony stimulating factor 1 (CSF-1) receptor. For more information,
please visit www.syndax.com or follow the Company
on Twitter and LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Words such as "may," "will," "expect," "plan," "anticipate,"
"estimate," "intend," "could," "believe" and similar expressions
(as well as other words or expressions referencing future events,
conditions or circumstances) are intended to identify
forward-looking statements. These forward-looking statements are
based on Syndax's expectations and assumptions as of the date of
this press release. Each of these forward-looking statements
involves risks and uncertainties. Actual results may differ
materially from these forward-looking statements. Forward-looking
statements contained in this press release include, but are not
limited to, statements about the progress, timing, clinical
development and scope of clinical trials, the reporting of clinical
data for Syndax's product candidates, the potential submission of
an NDA by year-end, and the potential use of our product candidates
to treat various cancer indications and fibrotic diseases. Many
factors may cause differences between current expectations and
actual results, including: unexpected safety or efficacy data
observed during preclinical or clinical trials; clinical trial site
activation or enrollment rates that are lower than expected;
changes in expected or existing competition; changes in the
regulatory environment; failure of Syndax's collaborators to
support or advance collaborations or product candidates; and
unexpected litigation or other disputes. Other factors that may
cause Syndax's actual results to differ from those expressed or
implied in the forward-looking statements in this press release are
discussed in Syndax's filings with the U.S. Securities and
Exchange Commission, including the "Risk Factors" sections
contained therein. Except as required by law, Syndax assumes no
obligation to update any forward-looking statements contained
herein to reflect any change in expectations, even as new
information becomes available.
Syndax Contact
Sharon Klahre
Syndax Pharmaceuticals, Inc.
sklahre@syndax.com
Tel 781.684.9827
SNDX-G
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SOURCE Syndax Pharmaceuticals, Inc.