--Retrospective analyses of the Phase 3
SIMPLIFY studies demonstrate safety and activity profile are not
impacted by baseline platelet
count--
VANCOUVER, BC, Dec. 7, 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 an updated efficacy analyses of momelotinib in
myelofibrosis patients with thrombocytopenia. The data were
presented in a poster presentation at the 2020 American Society of
Hematology Annual Meeting by Jean-Jacques
Kiladjian, MD, PhD, Consultant Hematologist, Head, Clinical
Investigation Center, Saint Louis Hospital, Paris, France.
"This retrospective analysis of the two Phase 3 SIMPLIFY studies
demonstrate that the relative benefit-risk profile of momelotinib
and ruxolitinib is influenced by baseline platelet count. What we
show in this analysis is that momelotinib's safety and activity
profile do not appear to be affected by baseline platelet count,
while in contrast, activity with ruxolitinib declined in patients
with lower baseline platelet counts," said Dr. Kiladjian. "These
updated data analyses complement previous findings that demonstrate
the ability to initiate and maintain near-maximal momelotinib dose
intensity regardless of baseline platelet count, suggesting that
this durable dosing contributes to its efficacy profile."
"These exciting data provide a novel insight into a patient
population where momelotinib's unique receptor inhibition
profile—JAK1, JAK2 & ACVR1—may be particularly relevant. The
observation of preserved activity in patients with reduced platelet
counts is provocative and potentially differentiating. The wealth
of information contained in the SIMPLIFY studies will enable
further analyses and potentially identify additional populations of
interest to be presented at future scientific meetings," said
Stephen Dilly, MBBS, PhD, Chief
Executive Officer at Sierra Oncology. "We now look forward to
completing enrollment in the pivotal Phase 3 MOMENTUM study and
subsequent topline data to support our plan to file for regulatory
approval of momelotinib for the treatment of myelofibrosis."
Momelotinib's Spleen, Symptom and Anemia Efficacy is
Maintained in Intermediate/High Risk Myelofibrosis Patients with
Thrombocytopenia (Abstract #3086)
Dr. Kiladjian presented comparative efficacy data for
momelotinib and ruxolitinib in patients with low platelets from the
SIMPLIFY-1 (S1) and SIMPLIFY-2 (S2) Phase 3 studies. Results from
the updated analyses include:
- In S1 (JAKi-naïve), patients whose baseline platelet counts
were:
-
- <150 x 109/L, momelotinib achieved substantially
higher TI (62% vs. 42%) and splenic response rates (23% vs. 4%) and
a similar symptomatic response (28% vs. 33%) relative to
ruxolitinib
- 150-300 x 109/L, generally similar splenic (35% vs.
32%) and symptom response rates (33% vs. 41%) and a higher TI
response rate (72% vs. 54%) were achieved with momelotinib relative
to ruxolitinib
- >300 x 109/L, ruxolitinib achieved higher splenic
(44% vs. 19%) and symptom response rates (46% vs. 23%) at week 24
than with momelotinib; the Week 24 TI rate remained higher with
momelotinib (63% vs. 51%)
- In S2 (JAKi-exposed patients):
-
- Momelotinib's response rates for the 3 response parameters
remain very consistent with overall ITT response rates in patients
whose baseline platelets were <150 x 109/L
- Momelotinib's symptomatic and anemia benefit were also
preserved in patients whose baseline platelet counts were <50
and >50-100 x 109/L
- In both S1 and S2, rates of TEAEs on momelotinib were generally
similar between the overall safety population and subjects with
baseline platelets <150 x 109/L
Patients were randomized 1:1 (S1) and 2:1 (S2) to receive
momelotinib (200 mg QD) versus ruxolitinib (20 mg BID) or best
available therapy (88.5% RUX/RUX+) for 24 weeks followed by
extended momelotinib treatment. A baseline platelet limit of >50
x 109/L was required in S1 while there was not lower
platelet limit for S2. 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.
View original
content:http://www.prnewswire.com/news-releases/sierra-oncology-announces-momelotinib-data-for-intermediate--high-risk-myelofibrosis-patients-with-lower-baseline-platelet-counts-301186719.html
SOURCE Sierra Oncology