- New analyses of Phase 3 data highlighting
momelotinib's meaningful anemia benefits in myelofibrosis presented
in a poster at the 61st American Society of Hematology
Annual Meeting -
- Analyst & Investor Event featuring renowned
myelofibrosis expert Dr. Ruben Mesa
scheduled for 7:00 am ET on Sunday,
December 8th -
VANCOUVER, Dec. 7, 2019 /PRNewswire/ - Sierra Oncology, Inc.
(Nasdaq: SRRA), a late-stage drug development company focused on
the development and commercialization of momelotinib, a JAK1, JAK2
& ACVR1 inhibitor with a potentially differentiated therapeutic
profile for the treatment of myelofibrosis, today reported new
analyses of Phase 3 clinical data highlighting the anemia related
benefits of momelotinib directly compared to ruxolitinib,
which were presented at the 61st American Society of
Hematology (ASH) Annual Meeting in Orlando, Florida.
"Transfusion dependency and moderate to severe anemia are the
most important negative prognostic factors for overall survival in
myelofibrosis," said Dr. Ruben Mesa,
Director of the Mays Cancer Center, home to UT Health San Antonio
MD Anderson Cancer Center. "These novel analyses of RBC transfusion
data from the Phase 3 SIMPLIFY-1 study further demonstrate
momelotinib's compelling anemia benefits, including a substantively
reduced transfusion burden compared directly with ruxolitinib, and
further support momelotinib as a potentially desirable treatment
option for patients with myelofibrosis."
"These retrospective analyses, performed using a variety of
novel dynamic anemia benefit endpoints, underscore the demonstrably
lower burden of transfusions experienced by myelofibrosis patients
treated with momelotinib versus ruxolitinib in a large, blinded,
randomized, clinical trial," said Dr. Nick
Glover, President and CEO of Sierra Oncology. "Momelotinib
uniquely inhibits ACVR1 in addition to JAK1 and JAK2, resulting in
an array of distinct and clinically relevant mechanistically-based
anemia benefits. While momelotinib's favorable effect on anemia was
previously demonstrated in direct comparison to ruxolitinib using a
variety of standard landmark analyses of data from SIMPLIFY-1,
these new analyses further describe the relative patient burden of
transfusions on study, and help contrast the differences in
therapeutic options for clinicians."
"Transfusion burden is a fundamental consideration in
myelofibrosis, a disease characterized by chronic, progressive
anemia. Specifically, preventing transfusions for patients who are
currently transfusion free, or reducing or eliminating the need for
transfusions for patients who are actively receiving regular blood
transfusions are clinically important outcomes of direct relevance
to myelofibrosis patients and their clinicians, underscoring the
importance of these data," said Dr. Barbara
Klencke, Chief Development Officer of Sierra Oncology.
"Myelofibrosis is a disease comprising three clinical dimensions –
constitutional symptoms, anemia and splenomegaly. Critically,
momelotinib's meaningful anemia benefits were achieved while also
maintaining clinically comparable benefits on splenomegaly and
constitutional symptoms as directly compared to ruxolitinib."
The new analyses demonstrate that:
- Patients who received momelotinib had significantly decreased
transfusion requirements compared to those treated with
ruxolitinib, including a nearly 10-fold higher odds of receiving no
transfusions during the 24-week study period (covariate ZINB model;
p < 0.0001).
- Patients receiving momelotinib had a significantly reduced
chance of receiving one transfusion, two 'transfusion events' (≥ 3
RBC units) or three 'transfusion events' (≥ 5 RBC units).
- At any given time, the mean cumulative number of RBC units
received for a typical patient receiving momelotinib is
approximately half of that for patients receiving ruxolitinib (HR =
0.522; p < 0.0001). Thus, for patients on momelotinib, half as
many RBC units are transfused at any time as compared to
ruxolitinib.
- A Kaplan-Meier time-to-first RBC unit transfused analysis
indicated an immediate and sustained momelotinib treatment effect
compared to ruxolitinib (log-rank p < 0.0001).
- A sustained and durable period of transfusion independence (TI)
was maintained over long-term treatment on momelotinib. The
median time to loss of TI was not reached for momelotinib-treated
patients, with a follow up period exceeding 3 years.
The SIMPLIFY-1 trial was a double-blind, active-controlled Phase
3 study in which 432 patients received randomized treatment with
momelotinib or ruxolitinib for 24 weeks (JCO. 2017; 35:3844–50). In
addition to a significant reduction in splenomegaly and
improvements in constitutional symptoms, previously reported
analyses of the SIMPLIFY-1 data demonstrated that patients in the
momelotinib arm achieved nominal-statistical significance for all
anemia endpoints tested, including a higher rate of transfusion
independence (p < 0.001) and lower rates of transfusion
dependence (p = 0.019) at Week 24, compared to patients on
ruxolitinib.
Sierra management will host an Analyst & Investor Event on
Sunday, December 8th at
7:00 am ET to discuss these results.
The event will include a presentation by renowned myelofibrosis
expert, Dr. Ruben Mesa, Director of
the Mays Cancer Center, home to UT Health San Antonio MD Anderson
Cancer Center.
Sierra recently launched the MOMENTUM Phase 3 clinical trial, a
randomized double-blind trial designed to enroll 180 myelofibrosis
patients who are symptomatic and anemic, and who have been treated
previously with a JAK inhibitor.
About Momelotinib
Momelotinib, Sierra's lead drug
candidate, is a potent, selective and orally-bioavailable JAK1,
JAK2 & ACVR1 inhibitor with a differentiated therapeutic
profile in myelofibrosis encompassing robust constitutional symptom
improvements, a range of meaningful anemia benefits, including
eliminating or reducing the need for frequent blood transfusions,
and comparable spleen control to ruxolitinib. More than 1,200
subjects have received momelotinib since clinical studies began in
2009, including more than 800 patients treated for
myelofibrosis.
Chronic, progressive anemia is a key hallmark of myelofibrosis
and transfusion dependence is the most important negative
prognostic indicator of reduced survival in this disease.
Approximately 60% of patients are anemic and 45% are transfusion
dependent within one year of diagnosis, with most patients
ultimately progressing to transfusion dependency. Unfortunately,
currently approved JAK inhibitor therapies can induce or worsen
anemia, exacerbating this significant unmet medical need in anemic
myelofibrosis patients.
The marked systemic inflammation seen in myelofibrosis leads to
increased ACVR1 activity which in turn increases secretion of
hepcidin, resulting in perturbed iron homeostasis and an
iron-restricted anemia. Momelotinib's inhibition of ACVR1 in
addition to JAK1 and JAK2, unique amongst the JAK inhibitor class,
results in notable reductions of both hepcidin and inflammation,
restoring iron homeostasis and RBC production, thereby alleviating
anemia and transfusion dependency.
Momelotinib is an investigational drug that is not approved for
any use in any country. The U.S. Food and Drug Administration has
granted Fast Track designation to momelotinib for the treatment of
patients with intermediate/high-risk myelofibrosis who have
previously received a JAK inhibitor. Momelotinib is wholly owned by
Sierra Oncology and is protected by patents anticipated to provide
potential exclusivity to 2040 in the
United States and Europe
(including Patent Term Extension or Supplementary Protection
Certificate).
Analyst and Investor Event and Webcast
Information
Sierra Oncology will host an Analyst &
Investor Event to discuss these data being presented at the 61st
American Society of Hematology (ASH) Annual Meeting in Orlando, Florida. The event will be led by Dr.
Nick Glover, President and CEO of
Sierra Oncology, and include a presentation by Dr. Ruben Mesa.
Date and Time: Sunday, December
8th at 7:00 – 8:00 am
ET
Location: Bayhill 33 Meeting Room, Hyatt Regency, 9801
International Dr., Orlando
Event registration and webcast information are available through
the Sierra Oncology website at www.sierraoncology.com. The event
will be webcast live, and an archive of the presentation will be
accessible after the event through the Sierra Oncology website.
Domestic (Toll Free- US): 1 (844) 467-7642
International (Toll): 1 (417) 385-2994
Conference ID: 3577956
Webcast: www.sierraoncology.com
Direct link: https://edge.media-server.com/mmc/p/y57zkifp
ASH 2019 Momelotinib Poster Presentation
Information:
Title: Dynamic and Time-To-Event Analyses
Demonstrate Marked Reduction in Transfusion Requirements for Janus
Kinase Inhibitor–Naïve Myelofibrosis Patients Treated with
Momelotinib Compared Head to Head with Ruxolitinib
Session Name: 634. Myeloproliferative Syndromes: Clinical: Poster
I
Date: Saturday, December
7th, 2019
Presentation Time: 5:30 pm - 7:30 pm
ET
Location: Orange County Convention
Center, Hall B
The poster will be available on Saturday,
December 7th, 2019 on the company's website at
www.sierraoncology.com
About Sierra Oncology
Sierra Oncology is a late stage
drug development company focused on advancing targeted therapeutics
for the treatment of patients with significant unmet medical needs
in hematology and oncology. Momelotinib, Sierra's lead drug
candidate, is a potent, selective and orally-bioavailable JAK1,
JAK2 & ACVR1 inhibitor with a differentiated therapeutic
profile in myelofibrosis encompassing robust constitutional symptom
improvements, a range of meaningful anemia benefits, including
eliminating or reducing the need for frequent blood transfusions,
and comparable spleen control to ruxolitinib.
Sierra is also developing a portfolio of DNA Damage Response
(DDR) assets, consisting of SRA737 and SRA141, and is conducting a
campaign intended to seek non-dilutive strategic options to support
their further advancement. SRA737 is a potent, highly selective,
orally bioavailable small molecule inhibitor of Checkpoint kinase 1
(Chk1), a key regulator of cell cycle progression and the DDR
network, and has demonstrated preliminary clinical efficacy. SRA141
is a potent, selective, orally bioavailable small molecule
inhibitor of Cell division cycle 7 kinase (Cdc7) with a potential
novel mechanism of cytotoxicity, and has successfully completed the
IND process with the FDA enabling the commencement of clinical
trials. Sierra retains the global commercialization rights to
SRA737 and SRA141.
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, the expected
timing of, and results of MOMENTUM, potential benefits of Sierra
Oncology's lead product candidate and other product candidates and
sufficiency of its capital resources. 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 develop and
commercialize product candidates, product candidates may not
demonstrate safety and efficacy or otherwise produce positive
results, Sierra Oncology may experience delays in the preclinical
and anticipated clinical development of its product candidates,
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's cash resources may be
insufficient to fund its current operating plans and it may be
unable to raise additional capital when needed, Sierra Oncology may
be unable to obtain and enforce intellectual property protection
for its technologies and product candidates 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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