Syros Announces Completion of Enrollment of 190 Patients Necessary to Support Primary Endpoint Analysis in SELECT-MDS-1 Phase 3 Trial
March 25 2024 - 7:00AM
Business Wire
-- On track to report pivotal complete response
data by mid-4Q 2024 --
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
enrollment of 190 patients has been completed in the SELECT-MDS-1
Phase 3 clinical trial evaluating tamibarotene in newly diagnosed
higher-risk myelodysplastic syndrome (HR-MDS) patients with RARA
gene overexpression. This initial cohort of 190 patients is
necessary to support the complete response (CR) primary endpoint
analysis. Syros expects to report these pivotal data by the middle
of the fourth quarter of 2024.
“We are pleased to announce the completion of enrollment of the
190 patients necessary to support the primary CR endpoint in
SELECT-MDS-1. This marks an important step in advancing
tamibarotene through late-stage clinical development and brings us
closer to delivering our RARα agonist as a frontline treatment
option for the approximately 50 percent of HR-MDS patients with
RARA overexpression,” said David A. Roth, M.D., Chief Medical
Officer of Syros. “We look forward to reporting pivotal data later
this year which, if successful, will allow us to file our first New
Drug Application (NDA) with the U.S. Food and Drug Administration
(FDA) and, ultimately, execute on our vision of fundamentally
changing the standard of care in hematologic malignancies.”
The Phase 3 SELECT-MDS-1 clinical trial is a double-blind,
placebo-controlled study evaluating tamibarotene in newly diagnosed
HR-MDS patients with RARA overexpression randomized 2:1 to receive
tamibarotene in combination with azacitidine or azacitidine alone.
The primary endpoint is CR rate in the first 190 patients enrolled
in the trial which, together with supporting durability data, can
serve as the basis for accelerated approval or full approval; the
key secondary endpoint in SELECT-MDS-1 is overall survival (OS) in
a total of 550 patients. This study design reflects an efficient
“one-trial” approach and could allow SELECT-MDS-1 to serve as a
confirmatory study, if needed, to convert from accelerated to full
approval. Enrollment is ongoing to reach the 550-patient
target.
Syros is also evaluating tamibarotene in combination with
venetoclax and azacitidine in the SELECT-AML-1 Phase 2 clinical
trial in newly diagnosed unfit acute myeloid leukemia patients with
RARA gene overexpression. Syros previously reported initial data
from the study, observing a 100% CR/CRi (complete response/complete
response with incomplete hematologic recovery) rate in
response-evaluable patients treated with the triplet regimen of
tamibarotene, venetoclax and azacitidine without increased
toxicity, as compared to 70% among patients treated with venetoclax
and azacitidine alone. Syros expects to report additional data from
SELECT-AML-1 in 2024. Read more here.
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 and acute myeloid
leukemia with RARA gene overexpression. For more information, visit
www.syros.com and follow us on Twitter (@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, the progression of its clinical trials,
the timing to report clinical data, and the ability to
commercialize tamibarotene and deliver benefit to patients. 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
Syros’ ability to: advance the development of its programs under
the timelines it projects in current and future clinical trials;
demonstrate in any current and future clinical trials the requisite
safety, efficacy and combinability of its drug candidates; sustain
the response rates and durability of response seen to date with its
drug candidates; successfully develop a companion diagnostic test
to identify patients with the RARA biomarker; obtain and maintain
patent protection for its drug candidates and the freedom to
operate under third party intellectual property; obtain and
maintain necessary regulatory approvals; identify, enter into and
maintain collaboration agreements with third parties; manage
competition; manage expenses; raise the substantial additional
capital needed to achieve its business objectives; attract and
retain qualified personnel; and successfully execute on its
business strategies; risks described under the caption “Risk
Factors” in Syros’ Annual Report on Form 10-K for the year ended
December 31, 2022 and Quarterly Reports on Form 10-Q for the
quarters ended March 31, 2023, June 30, 2023 and September 30,
2023, 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/20240325462203/en/
Syros Contact Karen Hunady Director of Corporate
Communications & Investor Relations 1-857-327-7321
khunady@syros.com
Investor Contact Hannah Deresiewicz Stern Investor
Relations, Inc. 212-362-1200 hannah.deresiewicz@sternir.com
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