-- 100% CR/CRi Rate in Patients Treated
with Tamibarotene, Venetoclax and Azacitidine Compared to 70% in
Patients Randomized to Treatment with Venetoclax and Azacitidine
Alone --
-- Triplet Regimen Continues to Demonstrate
Favorable Tolerability --
-- Additional Data Expected in 2024 --
-- Management to Host Conference Call at 8:30
a.m. ET Today --
Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical
company committed to advancing new standards of care for the
frontline treatment of hematologic malignancies, today announced
strong and encouraging initial data from its ongoing SELECT-AML-1
Phase 2 trial evaluating tamibarotene, an oral, selective, retinoic
acid receptor alpha (RARα) agonist, in combination with venetoclax
and azacitidine in newly diagnosed, unfit patients with acute
myeloid leukemia (AML) and RARA gene overexpression.
“I am highly encouraged by the initial data from the randomized
portion of SELECT-AML-1,” said Thomas Cluzeau, MD, PhD, Head of
Hematology at Nice University Hospital, Côte d’Azur University in
France. “Despite the recent advances in treatment for unfit AML
patients, there remains a substantial need for options that offer
higher response rates and improved overall survival, particularly
for the one-third of patients who do not respond to existing
standard-of-care. I believe tamibarotene may offer a significant
therapeutic advance for the treatment of AML and I am eager to
continue enrolling patients in the ongoing SELECT-AML-1 trial.”
“These data highlight the potential of tamibarotene to be a
cornerstone therapy for newly diagnosed, unfit AML patients with
RARA overexpression, further demonstrating its differentiated
product profile and validating our biologically targeted approach,”
said David A. Roth, M.D., Chief Medical Officer of Syros. “These
results -- the first from a randomized, controlled study --
demonstrate the potential impact of adding tamibarotene to the
standard-of-care, venetoclax and azacitidine and, importantly, are
consistent with prior experience. Across multiple clinical trials,
we have observed tamibarotene’s ability to rapidly deliver
clinically relevant activity, with a well-tolerated safety profile,
including in a combination setting. We look forward to advancing
our comprehensive clinical development program for tamibarotene,
with additional data from SELECT-AML-1 and pivotal complete
response data from our SELECT-MDS-1 trial in higher-risk
myelodysplastic syndrome with RARA overexpression expected next
year, as we work to deliver profound benefit to patients with
hematologic malignancies.”
Initial Data from SELECT-AML-1 Phase 2 Trial
SELECT-AML-1 is evaluating the safety and efficacy of
tamibarotene in combination with venetoclax and azacitidine
compared to venetoclax and azacitidine in approximately 80 patients
randomized 1:1. The trial is also evaluating the triplet regimen as
a salvage strategy in patients in the control arm who do not
respond to venetoclax and azacitidine. The primary endpoint of the
trial is complete response rate (CR)/complete response with
incomplete hematologic recovery (CRi). In December 2022, Syros
reported data from the safety lead-in portion of SELECT-AML-1, in
which five of six response evaluable patients (83%) achieved
CR/CRi.
As of November 13, 2023, 23 newly diagnosed unfit AML patients
positive for RARA overexpression had enrolled in the randomized
portion of the trial, including 19 who were evaluable for response.
The median age of the patients for the triplet arm was 77 (ranging
from 66-85) and the median age of the patients for the doublet arm
was 76 (ranging from 69-84).
Clinical Activity Data
- The primary endpoint (CR/CRi rate), defined in alignment with
ELN AML criteria (Dohner 2017 and Bloomfield 2018), was 100% among
response evaluable patients (nine of nine) treated with the
combination of tamibarotene, venetoclax and azacitidine, as
compared to 70% of patients (seven of ten) treated with the control
(venetoclax and azacitidine alone).
- Seven of the nine response evaluable patients (78%) treated
with the combination of tamibarotene, venetoclax and azacitidine
achieved a CR and two patients (22%) achieved a CRi.
- Three of the ten response evaluable patients (30%) treated with
the control achieved a CR and four patients (40%) achieved a
CRi.
- Median time to CR/CRi response was 21 days (ranging from
14-28) among patients treated with the combination of tamibarotene,
venetoclax and azacitidine, as compared to 25 days (ranging from
17-56) among patients treated with the control, with the CR/CRi
being reached by 100% of patients in the triplet arm by the end of
cycle one, compared with 60% of patients in the doublet control
arm.
Safety Data
- Consistent with prior clinical experience from the safety
lead-in portion of this study, tamibarotene administered in
combination with approved doses of venetoclax and azacitidine was
generally well tolerated, and the overall safety profile
demonstrated no additive toxicities or new safety signals, or
evidence of increased myelosuppression compared to treatment with
the doublet combination of venetoclax and azacitidine. The majority
of non-hematologic adverse events (AEs) were low-grade and
reversible, and rates of serious adverse events (SAEs) were
comparable between the study arms.
- Median duration of treatment was 66 days (ranging from 8-188)
among patients treated with the combination of tamibarotene,
venetoclax and azacitidine, and 75 days (ranging from 7-227) for
patients treated with the control. Patients will be followed for
duration of response, minimal residual disease (MRD)-negative
response, and survival.
Syros continues to enroll patients in SELECT-AML-1 and
anticipates reporting updated data from the trial in 2024.
Syros is also evaluating tamibarotene in combination with
azacitidine in the SELECT-MDS-1 Phase 3 clinical trial in newly
diagnosed higher-risk myelodysplastic syndrome patients with RARA
gene overexpression. Syros expects to complete patient enrollment
in SELECT-MDS-1 in the first quarter of 2024 and to report pivotal
CR data by the middle of the fourth quarter of 2024.
Conference Call and Webcast
Syros will host a conference call today at 8:30 a.m. ET to
discuss these data. To access the live conference call, please dial
(888) 259-6580 (domestic) or (416) 764-8624 (international) and
refer to conference ID 19696416. A webcast of the call will also be
available on the Investors & Media section of the Syros website
at www.syros.com. An archived replay of the webcast will be
available for approximately 30 days following the presentation.
Upcoming Investor Conference
Syros will also present at the JMP Securities Hematology and
Oncology Summit today. Management will participate in a fireside
chat at 11:00 a.m. ET. To access the live webcast and subsequent
archived recording of the event, please visit the Investors &
Media section of the Syros website at www.syros.com.
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, including with respect to the
progression of its clinical trials involving tamibarotene, the
timing and impact of upcoming clinical data readouts, the timing to
complete patient enrollment in SELECT-MDS-1, and the therapeutic
potential of tamibarotene. 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 Report on Form 10-Q for the quarter
ended 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231206147296/en/
Syros Karen Hunady Director of Corporate Communications
& Investor Relations 1-857-327-7321 khunady@syros.com
Investor Relations Hannah Deresiewicz Stern Investor
Relations, Inc. 212-362-1200 hannah.deresiewicz@sternir.com
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