– MOMENTUM data demonstrate potential use of
momelotinib in myelofibrosis patients who are symptomatic and
anemic –
– Additional data highlight improved
transfusion independence, symptoms and spleen volume of cytopenic
myelofibrosis patients –
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 Annual Meeting of the American
Society of Clinical Oncology (ASCO) being held June 3-7, 2022, in
Chicago and online. 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 an oral presentation
on June 7. An additional subset analysis from the trial evaluating
safety and efficacy for patients with low platelet counts has been
selected for poster presentation.
“Receiving an oral presentation at ASCO for our pivotal Phase 3
study data—which demonstrated that momelotinib achieved
statistically significant and clinically important efficacy across
all prespecified and key secondary endpoints—is truly a momentous
occasion for Sierra Oncology. Further, we are excited to present a
subset analysis in a poster presentation examining the use of
momelotinib in thrombocytopenic patients with platelet counts as
low as 25 x 109/L,” said Barbara Klencke, MD, Chief Medical Officer
at Sierra Oncology. “Together, these abstracts demonstrate the true
potential use of momelotinib as the treatment of choice across a
range of myelofibrosis patients who are symptomatic and cytopenic,
including those with anemia and thrombocytopenia.”
Abstract: 7002: 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 Ruben Mesa, MD,
co-Principal Investigator of the study. 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)
- SRR of >25% was 40% in the MMB
arm and 6% in the control arm
- A trend toward improved overall survival is demonstrated in the
MMB arm based on data up to Week 24 (p=0.0719) and overall
(p=0.3510)
- 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. The most frequent non-hematologic
adverse events were diarrhea, nausea, asthenia, pruritis and
increased blood creatinine
- Mean baseline characteristics for all patients were TSS of 27,
Hemoglobin (Hgb) of 8 g/dL and platelet count of 145 x 109/L
Abstract 7061: Thrombocytopenic Myelofibrosis (MF) Patients
Previously Treated with a JAK Inhibitor in a Phase 3 Randomized
Study of Momelotinib (MMB) versus Danazol (DAN) [MOMENTUM]
Abstract 7061 will highlight an analysis of MOMENTUM patients
with baseline platelet counts as low as 25 x 109/L on study
endpoints, including Week 24 TSS reduction of >50% from baseline, transfusion independence
rates, and SRR of >35% from
baseline. Results to be presented include:
- Of the 195 patients enrolled in the MOMENTUM study, 124, 100
and 31 patients had baseline platelet counts of less than 150, 100,
and 50 x 109/L, respectively.
- In patients with baseline platelets <100 x 109/L (MMB: n=66;
DAN: n=34): TSS responder proportion was 29% in the MMB arm and 15%
in the control arm; TI response proportion was 27% in the MMB arm
and 21% in the control arm; SRR was 20% in the MMB arm and 6% in
the control arm
- In patients with baseline platelets <50 x 109/L (MMB: n=18;
DAN: n=13): TSS responder proportion was 22% in the MMB arm and 8%
in the control arm; TI response proportion was 17% in the MMB arm
and 15% in the control arm; SRR was 22% in the MMB arm and 0% in
the control arm
- The broader thrombocytopenic subgroup with baseline platelets
<150 x 109/L demonstrated similar efficacy and safety as
described in the published abstract
- In patients with baseline platelets below 50 x 109/L, mean
platelet levels remained stable over time in both the MMB and
control arms
- Overall Survival directionally favored the MMB arm, consistent
with the survival results in the intent-to-treat population
- The proportion of patients who experience Grade 3 or higher
treatment-emergent adverse events were comparable between the study
arms
- Mean baseline characteristics for patients with baseline
platelets <100 x 109/L included TSS of 28 and 25 and Hgb of 8.1
and 7.8 g/dL for the MMB and control arms, respectively.
In thrombocytopenic, symptomatic and anemic patients with
myelofibrosis, including those with platelets as low as 25 x 109/L,
momelotinib was administered safely and demonstrated improvements
in symptom responses, transfusion independence rates and spleen
responses as compared to danazol. Consistent with the overall
intent-to-treat MOMENTUM population, platelets levels remained
stable over time, survival favored momelotinib versus danazol, and
the safety profile was generally maintained in thrombocytopenic
myelofibrosis patients receiving momelotinib.
Presentation Details
Abstract 7002 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: Ruben Mesa, MD, FACP, Executive Director of the Mays
Cancer Center, home to UT Health San Antonio, MD Anderson Cancer
Center Session Title: Oral Abstract Session: Hematologic
Malignancies—Leukemia, Myelodysplastic Syndromes, and
Allotransplant Presentation Date and Time: Tuesday, June 7, 2022,
10:33 am CT
Abstract 7061 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: Aaron Gerds, MD, MS, Taussig Cancer
Institute, Cleveland Clinic Session Title: Hematologic
Malignancies—Leukemia, Myelodysplastic Syndromes, and
Allotransplant Session Date and Time: Saturday, June 4, 2022, 8:00
am – 11:00 am CT
About Momelotinib Momelotinib is a potent, selective and
orally bioavailable ACVR1 / ALK2, JAK1, JAK2 inhibitor under
investigation for the treatment of myelofibrosis in symptomatic,
anemic patients previously treated with an approved JAK inhibitor.
More than 1,200 subjects have received momelotinib since clinical
studies began in 2009, including approximately 1,000 patients
treated for myelofibrosis, several of whom remain on treatment for
over 11 years. Momelotinib is the first and only JAK inhibitor to
demonstrate positive data for all key hallmarks of the
disease—symptoms, splenic response and anemia.
About Myelofibrosis Myelofibrosis is a rare blood cancer
that results from dysregulated JAK-STAT signaling and is
characterized by constitutional symptoms, splenomegaly (enlarged
spleen) and progressive anemia. From prior studies with
momelotinib, we know approximately half of myelofibrosis patients
are moderately to severely anemic when eligible for JAK inhibitor
treatment. Furthermore, currently approved JAK inhibitors only
address symptoms and splenomegaly and are myelosuppressive. This
can lead to worsening anemia, resulting in dose reductions that
potentially reduce treatment effect.
About the Pivotal MOMENTUM Clinical Trial MOMENTUM is a
global, randomized, double-blind Phase 3 clinical trial of
momelotinib versus danazol in patients with myelofibrosis who were
symptomatic and anemic, and had been previously treated with an
FDA-approved JAK inhibitor. The study was designed to evaluate the
safety and efficacy of momelotinib for the treatment and reduction
of the key hallmarks of disease: symptoms, blood transfusions (due
to anemia) and splenomegaly (enlarged spleen).
The primary endpoint of the study is Total Symptom Score (TSS)
reduction of >50% over the 28 days
immediately prior to the end of Week 24 compared to baseline TSS,
using the Myelofibrosis Symptom Assessment Form (MFSAF). Secondary
endpoints included Transfusion Independence (TI) rate for
>12 weeks immediately prior to the
end of Week 24 with Hgb levels ≥ 8 g/dL, and Splenic Response Rate
(SRR) based on splenic volume reduction of >35% at Week 24. The study enrolled 195
patients based on a planned 180 patients across 21 countries.
Danazol was selected as the treatment comparator given its use
to ameliorate anemia in patients with myelofibrosis, as recommended
by National Comprehensive Cancer Network (NCCN) and European
Society of Medical Oncology (ESMO) guidelines. Patients were
randomized 2:1 (MMB n = 130 and DAN n = 65) to receive either
momelotinib or danazol. After 24 weeks of treatment, patients on
danazol were allowed to crossover to receive momelotinib. Early
cross-over to momelotinib was available for confirmed symptomatic
splenic progression.
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'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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