Sierra Oncology Announces Oral Presentation of Momelotinib Pivotal Phase 3 Data at European Hematology Association Annual Meeting
May 12 2022 - 10:00AM
Business Wire
– Oral presentation of MOMENTUM pivotal phase 3
data in myelofibrosis patients who are symptomatic and anemic –
– Poster presentation to highlight improved
transfusion independence, symptoms and spleen volume of these
myelofibrosis patients who also present with thrombocytopenia –
Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage
biopharmaceutical company on a mission to deliver transformative
therapies for rare cancers, today announced two abstracts have been
accepted into the program for the 2022 Annual Meeting of the
European Hematology Association (EHA). An abstract presenting the
full data from the pivotal phase 3 MOMENTUM study in myelofibrosis
patients who are symptomatic and anemic has been selected for oral
presentation. Additionally, a subset analysis from the trial
evaluating safety and efficacy for patients with low platelet
counts has been selected for poster presentation.
“We are excited and honored to have the MOMENTUM data selected
for an oral presentation at EHA which demonstrates that momelotinib
achieved statistically significant and clinically important
efficacy across all prespecified primary and key secondary
endpoints,” said Barbara Klencke, MD, Chief Medical Officer of
Sierra Oncology. “In addition, we are pleased to present the subset
analysis in a poster presentation which indicates momelotinib may
be safely administered and provide an improvement in symptoms,
spleen and anemia in anemic myelofibrosis patients who present with
low platelet counts. The data to be presented further expand upon
the potential of momelotinib as a treatment option for
myelofibrosis patients who are symptomatic and anemic.”
Abstract: S195: MOMENTUM: Phase 3 Randomized Study of
Momelotinib (MMB) versus Danazol (DAN) in Symptomatic and Anemic
Myelofibrosis (MF) Patients Previously Treated with a JAK
Inhibitor
The primary and all key secondary results, as well as safety
data, from the MOMENTUM pivotal Phase 3 trial of momelotinib will
be presented in an oral presentation by Srdan Verstovsek, MD, PhD,
co-Principal Investigator of the study. Topline results from the
study were announced in January 2022. Key data to be presented
include:
- Primary Endpoint of Total Symptom Score (TSS) of >50%: 25% in the MMB arm vs. 9% in the control
arm (p=0.0095)
- Secondary Endpoint of Transfusion Independence (TI): 31% in the
MMB arm vs. 20% in the control arm (one-sided p=0.0064;
non-inferiority)
- Secondary Endpoint of Splenic Response Rate (SRR) >35%: 23% in the MMB arm vs. 3% in the control
arm (p=0.0006)
- The rate of Grade 3 or worse adverse events in the randomized
treatment period was 54% in the MMB arm and 65% in the control arm.
Serious treatment emergent adverse events were 35% in the MMB arm
and 40% in the control arm.
- Mean baseline characteristics for all patients were TSS of 27,
Hemoglobin (Hgb) of 8 g/dL and platelet count of 145 x 109/L
Presentation Details
Abstract: S195 Title: MOMENTUM: Phase 3 Randomized
Study of Momelotinib (MMB) versus Danazol (DAN) in Symptomatic and
Anemic Myelofibrosis (MF) Patients Previously Treated with a JAK
Inhibitor Presenter: Srdan Verstovsek, MD, PhD, The
University of Texas MD Anderson Cancer Center Session Title:
Treatments and Complications in MPN Location: Hall Lehar 1-2
Date and Time: Saturday, June 11, 2022, 11:30 am – 12:45 pm
CEST
Abstract: P1050: Thrombocytopenic Myelofibrosis (MF) Patients
Previously Treated with a JAK Inhibitor in a Phase 3 Randomized
Study of Momelotinib (MMB) versus Danazol (DAN) [MOMENTUM]
Abstract P1050 will highlight an analysis of MOMENTUM patients
with baseline platelet counts of <150 x 109/L on key symptom, anemia and spleen
volume endpoints at 24 weeks. Results to be presented are
consistent with the overall intent-to-treat analysis set.
Momelotinib was superior to danazol for symptom responses,
transfusion requirements and spleen responses, and showed a trend
toward improved overall survival up to Week 24 was seen with
momelotinib versus danazol [95% CI = 0.490 (0.195, 1.235)].
Presentation Details
Abstract: P1050 Title: Thrombocytopenic
Myelofibrosis (MF) Patients Previously Treated with a JAK Inhibitor
in a Phase 3 Randomized Study of Momelotinib (MMB) versus Danazol
(DAN) [MOMENTUM] Presenter: Alessandro Vannucchi, MD, Center
Research and Innovation for Myeloproliferative Neoplasms, AOU
Careggi, University of Florence, Italy Session Title: Poster
Session Date and Time: Friday, June 10, 2022, 4:30 – 5:45 pm
CEST
About Sierra Oncology Sierra Oncology is a late-stage
biopharmaceutical company on a mission 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 regarding the potential
and future success 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 may be unable to successfully
commercialize 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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Investor Contact DeDe Sheel
415.732.9828 dsheel@sierraoncology.com Media
Contact Lauren Musto 615.351.7777
lmusto@sierraoncology.com
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