Syros Announces Topline Data from SELECT-MDS-1 Phase 3 Trial of Tamibarotene in Higher-Risk Myelodysplastic Syndrome with RARA Gene Overexpression
November 12 2024 - 4:30PM
Business Wire
-- SELECT-MDS-1 Did Not Meet its Primary
Endpoint --
-- Company to Discontinue Study, Review Full
Data Set, and Evaluate Next Steps --
Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company
committed to advancing new standards of care for the frontline
treatment of hematologic malignancies, today announced that the
SELECT-MDS-1 Phase 3 trial evaluating tamibarotene in combination
with azacitidine in newly diagnosed higher-risk myelodysplastic
syndrome (HR-MDS) patients with RARA gene overexpression did not
meet its primary endpoint of complete response (CR) rate.
Tamibarotene is Syros’ proprietary oral, selective, retinoic acid
receptor alpha (RARα) agonist.
In the first 190 enrolled patients, the CR rate by
intent-to-treat (ITT) in the tamibarotene/azacitidine treatment arm
was 23.8% (n=126; 95% CI: 16.7%-32.2%) compared to a CR rate of
18.8% (n=64; 95% CI: 10.1%-30.5%) in the placebo/azacitidine
control arm and was not statistically significant (p-value =
0.2084). In the safety analysis of all enrolled patients (n=245),
tamibarotene in combination with azacitidine (n=160) appeared to be
generally well-tolerated, with an adverse event profile that was
similar to that seen in earlier Syros-sponsored studies.
Syros also reported that, as previously disclosed in its filings
with the SEC, the failure of the SELECT-MDS-1 trial to achieve its
primary endpoint constitutes an event of default under its secured
loan facility with Oxford Finance LLC.
“We are deeply disappointed by this outcome, particularly for
the HR-MDS patients who are seeking a new treatment option for this
challenging disease,” said Conley Chee, Chief Executive Officer of
Syros. “We plan to stop the study, review the clinical data more
thoroughly, and evaluate the next steps. We want to express our
sincere appreciation for the patients, caregivers and healthcare
professionals who took part in the SELECT-MDS-1 trial and to all
the employees of Syros for their exceptional work on the
tamibarotene program.”
About SELECT-MDS-1 Phase 3 Trial
SELECT-MDS-1 is a multinational Phase 3 randomized,
double-blind, placebo-controlled trial evaluating the safety and
efficacy of tamibarotene in combination with azacitidine compared
to placebo and azacitidine in HR-MDS patients with RARA
overexpression. The primary endpoint of the trial was the CR rate
in the first 190 patients.
About Syros Pharmaceuticals
Syros is committed to developing new standards of care for the
frontline treatment of patients with hematologic malignancies.
Driven by the motivation to help patients with blood disorders that
have largely eluded other targeted approaches, Syros is developing
tamibarotene, an oral selective RARα agonist in frontline patients
with higher-risk myelodysplastic syndrome with RARA gene
overexpression. For more information, visit www.syros.com and
follow us on X (@SyrosPharma) and LinkedIn.
Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995, including without limitation statements regarding Syros’
clinical development plans and the ongoing review of clinical data
from the SELECT-MDS-1 trial. The words “anticipate,” “believe,”
“continue,” “could,” “estimate,” “expect,” “hope,” “intend,” “may,”
“plan,” “potential,” “predict,” “project,” “target,” “should,”
“would,” and similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. Actual results or
events could differ materially from the plans, intentions and
expectations disclosed in these forward-looking statements as a
result of various important factors, including those risks
described under the caption “Risk Factors” in Syros’ Annual Report
on Form 10-K for the year ended December 31, 2023 and Quarterly
Report on Form 10-Q for the quarter ended September 30, 2024, each
of which is on file with the Securities and Exchange Commission,
and risks described in other filings that Syros makes with the
Securities and Exchange Commission in the future.
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version on businesswire.com: https://www.businesswire.com/news/home/20241112019957/en/
Syros Karen Hunady Director of Corporate Communications
& Investor Relations 1-857-327-7321 khunady@syros.com
Investor Amanda Isacoff Precision AQ 212-362-1200
amanda.isacoff@precisionaq.com
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