- Efficacy data for momelotinib in myelofibrosis
patients by baseline platelet levels also to be presented -
VANCOUVER, BC, Nov. 5, 2020 /PRNewswire/ - Sierra Oncology,
Inc. (SRRA), a late-stage biopharmaceutical company focused on the
Phase 3 execution, registration and potential commercialization of
momelotinib, a novel drug that may address serious unmet needs in
myelofibrosis, today announced two abstracts have been selected for
presentation at the 62nd American Society of Hematology (ASH)
Annual Meeting being held December 5-8,
2020.
"Data presented at this year's ASH annual meeting may support
the potential of momelotinib as a unique treatment option for
myelofibrosis patients, capable of improving all three hallmarks of
disease: anemia, symptoms and spleen," said Barbara Klencke, M.D., Chief Development Officer
at Sierra Oncology. "Further, activity is demonstrated in
thrombocytopenic patients, regardless of previous treatment with a
JAK inhibitor. Collectively, the additional data presented from the
SIMPLIFY-1 and SIMPLIFY-2 clinical trials may demonstrate potential
long-term survival, and the possibility that more patients may
become transfusion independent. A similar clinical profile has not
been seen with other agents at this time."
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
Long-term overall survival data from the previously completed
SIMPLIFY-1 and SIMPLIFY-2 Phase 3 trials will be reported in an
oral presentation 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, Houston, Texas. The
trials evaluated JAK inhibitor-naïve and previously JAK
inhibitor-treated patients with myelofibrosis who were either
randomized to receive momelotinib or were dosed initially with
ruxolitinib or best available therapy followed by momelotinib.
Presentation Details
Abstract: 54
Title: 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
Presenter: Srdan Verstovsek, MD, PhD
Session Name: 634. Myeloproliferative Syndromes: Clinical: New
Therapies and JAKi-based Combinations for Myelofibrosis
Session Information: Saturday, December 5,
2020; 7:30 AM - 9:00 AM PT
Presentation Time: 8:15 AM PT
Momelotinib's Spleen, Symptom and Anemia Efficacy is
Maintained in Intermediate/High Risk Myelofibrosis Patients with
Thrombocytopenia
Comparative efficacy data for momelotinib and ruxolitinib in
patients with low platelets from SIMPLIFY-1 and SIMPLIFY-2 will be
presented in a poster presentation by Jean-Jacques Kiladjian, MD, PhD, Professor of
Clinical Pharmacology, Paris Diderot University; Consultant
Hematologist, Head, Clinical Investigation Center, Saint Louis
Hospital, Paris, France. The
presentation will include post-hoc comparative efficacy analyses
for momelotinib and ruxolitinib for spleen, symptom and transfusion
independence response in patients with baseline platelet counts of
<150 x 109/L versus the ITT populations from the two
previously completed global Phase 3 SIMPLIFY studies. A
baseline platelet limit of ≥50 × 109/L was required in
SIMPLIFY-1 while there was no lower platelet limit for
SIMPLIFY-2. In SIMPLIFY-2, most patients randomized to best
available therapy (88%) received ruxolitinib during the
randomization period.
Presentation Details
Abstract: 3086
Title: Momelotinib's Spleen, Symptom and Anemia Efficacy is
Maintained in Intermediate/High Risk Myelofibrosis Patients with
Thrombocytopenia
Presenter: Jean-Jacques Kiladjian, MD, PhD
Session Name: 634. Myeloproliferative Syndromes: Clinical: Poster
III
Session Information: Monday, December 7,
2020; 7:00 AM - 3:30 PM
PT
About Sierra Oncology
Sierra Oncology is a late stage
biopharmaceutical company focused on the Phase 3 execution,
registration and potential commercialization of momelotinib, a
novel drug that may address serious unmet needs in myelofibrosis.
Momelotinib is a selective and orally bioavailable JAK1, JAK2 &
ACVR1 inhibitor with a differentiated mechanism of action that
enables it to potentially address all three key drivers of
myelofibrosis: anemia of inflammation, constitutional symptoms and
enlarged spleen. More than 1,200 subjects have received momelotinib
since clinical studies began in 2009, including more than 800
patients treated for myelofibrosis. Several of these patients
remain on treatment for more than 10 years.
Sierra is enrolling symptomatic and anemic patients, who have
been treated previously with a JAK inhibitor in MOMENTUM, a
randomized double-blind Phase 3 clinical trial. The U.S. Food and
Drug Administration has granted Fast Track designation to
momelotinib.
For more information, please
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