--Momelotinib demonstrates robust overall
survival in both JAKi-naïve and patients previously treated with
ruxolitinib--
VANCOUVER, BC, Dec. 5, 2020 /CNW/ - Sierra Oncology, Inc.
(SRRA), a late-stage biopharmaceutical company on a quest to
deliver targeted therapies that treat rare forms of cancer, today
reported updated overall survival (OS) data for momelotinib in both
JAKi-naïve and patients previously treated with ruxolitinib. The
data were presented in an oral presentation at the 2020 American
Society of Hematology Annual Meeting by Srdan Verstovsek, MD, PhD,
Chief, Section for Myeloproliferative Neoplasms, Department of
Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center.
"Momelotinib's unique mechanism of action—targeting JAK1, JAK2
and ACVR1—is translating to durability of activity and survival
data consistent with its clinical and biologic profile," said Dr.
Verstovsek. "Notably, momelotinib showed improved rates in
transfusion independence and the duration thereof as well as
overall survival, and that benefit was present regardless of
whether or not the patient was previously treated with a JAK
inhibitor."
"As the SIMPLIFY data sets continue to mature, we are seeing
increasingly exciting outcomes in terms of overall survival, as
well as myelofibrosis disease hallmarks, including splenic response
and transfusion independence," said Barbara
Klencke, MD, Chief Development Officer at Sierra Oncology.
"We believe these data presented at the ASH annual meeting, in
combination with previously reported safety data, tell a truly
innovative story for how momelotinib can fulfill an unmet need for
intermediate and high-risk myelofibrosis patients who are not ideal
candidates for currently approved therapies. We look forward to
continuing enrollment in the Phase 3 MOMENTUM study to further
highlight where momelotinib may be a preferred treatment option for
patients and their physicians."
Robust Overall Survival and Sustained Efficacy Outcomes
During Long Term Exposure to Momelotinib in JAK Inhibitor Naïve and
Previously JAK Inhibitor Treated Intermediate/High Risk
Myelofibrosis Patients (Abstract #54)
The SIMPLIFY-1 (S1) and SIMPLIFY-2 (S2) Phase 3 studies
evaluated momelotinib (MMB) against ruxolitinib (S1) or best
available therapy (S2) for a 24-week randomization treatment phase,
followed by an opportunity for extended momelotinib treatment for
all patients. Results based on a total 588 patients presented by
Dr. Verstovsek include:
- Robust OS was observed in both JAKi-naïve and previously
ruxolitinib-treated patients
-
- In S1, the median OS has not been reached in the MMB arm and
53.1 months in the control arm (HR=0.99, p=0.97)
- In S2, the median OS was 34.3 months in originally
MMB-randomized patients and 37.5 months in the BAT/RUXàMMB arm
(HR=0.96, p=0.86), representing the best reported OS in this
previously RUX-treated setting
- Sustained transfusion independence was observed with extended
MMB treatment
-
- In S1, TI response at Week 24 was 67% in the MMB arm and 49% in
the control arm (p<0.001). 40% of MMB-treated patients achieved
a splenic response at any time during S1
-
- The median duration of TI has not been reached after >3
years of follow up
- In S2, TI response at Week 24 was 43% in the MMB arm and 21% in
the control arm (p=0.001)
- Compound safety was favorable for MMB with limited
hematological toxicity and lack of cumulative toxicity
Patients were randomized 1:1 (S1) and 2:1 (S2) to receive MMB
(200 mg QD) versus RUX (20 mg BID) or BAT (88.5% RUX/RUX+) for 24
weeks followed by extended momelotinib treatment. Both trials had
primary endpoints of Splenic Response Rate and secondary endpoints
of Total Symptom Score and Transfusion Independence Rate.
About Momelotinib
Momelotinib is a selective and orally bioavailable JAK1, JAK2
and ACVR1 inhibitor currently under investigation for the treatment
of myelofibrosis. Myelofibrosis results from dysregulated JAK-STAT
signaling and is characterized by constitutional symptoms,
splenomegaly (enlarged spleen) and progressive anemia.
Momelotinib is currently under investigation in the MOMENTUM
clinical trial, a global, randomized, double-blind Phase 3 study
for symptomatic and anemic myelofibrosis patients. Top-line data
are anticipated in H1 2022. The U.S. Food & Drug Administration
has granted Fast Track designation for momelotinib.
About Sierra Oncology
Sierra Oncology is a late-stage biopharmaceutical company on a
quest to deliver targeted therapies that treat rare forms of
cancer. We harness our deep scientific expertise to identify
compounds that target the root cause of disease to advance targeted
therapies with assets on the leading edge of cancer biology. Our
team takes an evidence-based approach to understand the limitations
of current treatments and explore new ways to change the cancer
treatment paradigm. Together we are transforming promise into
patient impact.
For more information, visit www.SierraOncology.com.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995, including, but not
limited to, statements regarding Sierra Oncology's expectations
from current data, anticipated clinical development activities,
expected timing and success of enrollment of MOMENTUM and potential
benefits of momelotinib. All statements other than statements of
historical fact are statements that could be deemed forward-looking
statements. These statements are based on management's current
expectations and beliefs and are subject to a number of risks,
uncertainties and assumptions that could cause actual results to
differ materially from those described in the forward-looking
statements. Such forward-looking statements are subject to risks
and uncertainties, including, among others, the risk that Sierra
Oncology's cash resources may be insufficient to fund its current
operating plans and it may be unable to raise additional capital
when needed, the risk that disruptions and impacts of COVID-19 will
be significant and lengthy, Sierra Oncology may be unable to
successfully develop and commercialize momelotinib,
momelotinib may not demonstrate safety and efficacy or
otherwise produce positive results, Sierra Oncology may experience
delays in the clinical development of momelotinib, Sierra Oncology
may be unable to acquire additional assets to build a pipeline of
additional product candidates, Sierra Oncology's third-party
manufacturers may cause its supply of materials to become limited
or interrupted or fail to be of satisfactory quantity or quality,
Sierra Oncology may be unable to obtain and enforce intellectual
property protection for its technologies and momelotinib and the
other factors described under the heading "Risk Factors" set forth
in Sierra Oncology's filings with the Securities and Exchange
Commission from time to time. Sierra Oncology undertakes no
obligation to update the forward-looking statements contained
herein or to reflect events or circumstances occurring after the
date hereof, other than as may be required by applicable law.
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SOURCE Sierra Oncology