- Data presented at the 25th European
Hematology Association (EHA) Virtual Congress further demonstrate
the potential anemia benefits and favorable hematological safety
profile of momelotinib -
- Long-term tolerability facilitates sustained dose intensity and
prolonged clinical activity; longest ongoing treatment now extends
to 10 years -
VANCOUVER, BC, June 12, 2020 /PRNewswire/ - Sierra
Oncology, Inc. (NASDAQ: SRRA), a late-stage drug development
company focused on the registration and commercialization of
momelotinib, a JAK1, JAK2 & ACVR1 inhibitor with a potentially
differentiated therapeutic profile for the treatment of
myelofibrosis, announced that Long-Term Safety and Dose Intensity
data for momelotinib are being presented today in two posters at
the 25th European Hematology Association (EHA) Virtual
Congress.
More than 820 patients with myelofibrosis have received
momelotinib during its development, including a number of patients
who remain on treatment since the start of the original Phase 2
studies initiated a decade ago. One of these patients will reach a
major milestone this week, having received momelotinib therapy for
10 years, highlighting the relevance of the long-term dosing and
safety data for momelotinib being presented this week at EHA. The
data presented at EHA draw from more than 550 patients across the
two previously conducted SIMPLIFY Phase 3 studies and their
subsequent ongoing extended treatment periods. More than 90
SIMPLIFY-1 and SIMPLIFY-2 patients continued to receive momelotinib
for 3.5 years or longer.
"Consistent with prior data, and reflecting momelotinib's
differentiated pharmacological profile, our new long-term safety
analyses continue to show a rapid and sustained increase in
hemoglobin levels during momelotinib therapy, in contrast to the
significant decrease in hemoglobin for patients receiving
ruxolitinib. Patients treated with momelotinib also experienced
significantly higher mean platelet counts compared to those
receiving ruxolitinib. Importantly, patients who switched from
ruxolitinib to momelotinib also achieved a sustained improvement in
both hemoglobin and platelets," said Prof. Claire Harrison, Guy's and St. Thomas' NHS Foundation Trust, London, United Kingdom. "In addition to an
absence of significant rates of high-grade hematological
toxicities, long-term tolerability was favorable with no new safety
signals or evidence of cumulative toxicity. Notably, this was
achieved with most patients receiving full-dose momelotinib."
"Momelotinib's safety profile and durable anemia benefits
facilitated sustained dose intensity across the continuum of JAK
inhibitor naïve and previously JAK inhibitor treated myelofibrosis
patients. While the starting doses for ruxolitinib were often
attenuated due to low platelets, further reductions in dose
intensity were also commonly required for ruxolitinib. In
contrast, momelotinib was initiated at full dose for all
subjects enrolled to the SIMPLIFY studies and high dose intensity
was maintained in the majority over extended durations," said Dr.
Vikas Gupta, Princess Margaret
Cancer Centre, Toronto, Canada.
"The ability to safely dose momelotinib sustainably at high dose
intensity likely facilitates its ability to durably control the
cardinal features of myelofibrosis, namely anemia, constitutional
symptoms, and splenomegaly. Furthermore, patients who switch from
ruxolitinib to momelotinib saw an immediate and sustained
improvement in dose intensity, suggesting a link to the
corresponding improvements in hemoglobin and platelets noted by
Prof. Harrison. These data suggest that momelotinib may be an
optimal therapy in myelofibrosis patients, in particular those
experiencing hematological toxicity and disease-related
myelosuppression, which are significant unmet needs in this
disease."
The SIMPLIFY-1 trial was conducted in JAKi-naïve myelofibrosis
patients (n=432) randomized 1:1 to momelotinib or ruxolitinib for
24 weeks. The SIMPLIFY-2 trial was conducted in prior
ruxolitinib-treated myelofibrosis patients with hematological
toxicity (n=156) randomized 2:1 to momelotinib or best available
therapy (consisting of ruxolitinib in 88% of patients) for 24
weeks. All patients were then subsequently allowed to receive
momelotinib for an extended treatment period including those who
did not receive momelotinib initially, as they were eligible to
cross-over to momelotinib at the end of the 24-week randomized
treatment period in both studies.
About the Posters:
Please visit www.sierraoncology.com
to view Prof. Harrison and Dr. Gupta present the momelotinib
Long-Term Safety and Dose Intensity posters. Both e-posters are
available through the on-demand EHA Virtual Congress platform at
https://ehaweb.org/
Title: Long term Safety of Momelotinib in JAKi Naïve and
Previously JAKi Treated Intermediate/High Risk Myelofibrosis
Patients
Lead Author: Prof. Claire Harrison,
Guy's and St. Thomas' NHS
Foundation Trust, London, United
Kingdom
Session Title: Myeloproliferative neoplasms - Clinical
Poster No.: EP1113
Title: Momelotinib Dose-Intensity is Maintained in JAKi Naïve
and Previously JAKi Treated Intermediate/High Risk Myelofibrosis
Patients
Lead Author: Dr. Vikas Gupta,
Princess Margaret Cancer Centre, Toronto,
ON, Canada
Session Title: Myeloproliferative neoplasms - Clinical
Poster No.: EP1103
About Sierra Oncology
Sierra Oncology is a late stage
drug development company focused on achieving the successful
registration and commercialization of momelotinib, a potent,
selective and orally-bioavailable JAK1, JAK2 & ACVR1 inhibitor
with a targeted mechanism of action that enables it to address all
three key drivers of myelofibrosis. Momelotinib's differentiated
therapeutic profile encompasses 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 820 patients treated for
myelofibrosis.
Sierra has launched MOMENTUM, a randomized double-blind Phase 3
clinical trial designed to enroll 180 myelofibrosis patients who
are symptomatic and anemic, and who have been treated previously
with a JAK inhibitor. The U.S. Food and Drug Administration has
granted Fast Track designation to momelotinib. Momelotinib is
protected by patents anticipated to provide potential exclusivity
to 2040 in the United States and
Europe (inclusive of potential
Patent Term Extension or Supplementary Protection Certificate).
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, 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