Gilead Announces Top-Line Results From Two Phase 3 Studies Evaluating Momelotinib for Patients With Myelofibrosis
November 16 2016 - 4:15PM
Business Wire
Gilead Sciences, Inc. (Nasdaq: GILD) today announced top-line
results from two Phase 3 clinical trials (SIMPLIFY 1 and 2)
evaluating momelotinib, an investigational inhibitor of Janus
kinase (JAK) compared to ruxolitinib or best alternative therapy
(BAT) in patients with myelofibrosis. The SIMPLIFY-1 study achieved
its pre-specified primary endpoint of non-inferiority to
ruxolitinib for splenic response rate at Week 24 (SRR24), defined
as the percentage of patients experiencing a ≥ 35 percent reduction
in spleen volume (momelotinib: 26.5%; ruxolitinib: 29.0%; 95
percent CI: -11.2% to +5.6%; p=0.011).
Non-inferiority was not achieved for the key secondary endpoint
of response rate in total symptom score (TSS). Greater improvements
in all three pre-specified anemia-related secondary endpoints
(proportion of patients who are transfusion independent, or
transfusion dependent and transfusion rate) were observed in
patients receiving momelotinib compared to ruxolitinib. However,
because the TSS response rate did not meet the non-inferiority
test, formal sequential statistical testing was not undertaken for
these three additional anemia secondary endpoints.
During 24 weeks of treatment in SIMPLIFY-1, the most frequent
adverse events in patients receiving momelotinib were
thrombocytopenia, diarrhea, headache, dizziness and nausea; the
most frequent adverse events in patients receiving ruxolitinib were
anemia, thrombocytopenia, diarrhea, headache and dizziness. Ten
percent of patients receiving momelotinib reported peripheral
neuropathy (any grade) compared to five percent of
ruxolitinib-treated patients. There was no Grade ≥3 peripheral
neuropathy in momelotinib-treated patients and one case in
ruxolitinib-treated patients during 24 weeks of treatment.
SIMPLIFY-2 did not achieve its primary endpoint of superiority
of momelotinib compared to BAT in patients previously treated with
ruxolitinib in SRR24 (momelotinib: 6.7%; BAT: 5.8%; 95 percent CI:
-8.9% to +10.2%; p=0.90). Eighty-eight percent of patients
randomized to the BAT arm continued to receive ruxolitinib; the
remainder of patients received chemotherapy, interferon,
corticosteroids, other therapies or some combination thereof.
Differences in favor of momelotinib were observed for the
pre-specified secondary endpoints of TSS and one of the three
anemia-related endpoints (transfusion independence), however,
formal sequential statistical testing was not undertaken because
the primary superiority endpoint was not achieved.
“The results from both the SIMPLIFY-1 and SIMPLIFY-2 studies
indicate that momelotinib provides some treatment benefit,
including benefit on anemia-related endpoints,” said Norbert
Bischofberger, PhD, Executive Vice President of Research and
Development and Chief Scientific Officer. “We plan to discuss these
results with regulatory authorities to determine the next
steps.”
Detailed results from both studies will be submitted for
presentation at upcoming scientific conferences.
Momelotinib is an investigational therapy and has not been
proven safe or efficacious.
About the SIMPLIFY
Studies
The SIMPLIFY studies were randomized, Phase 3 clinical trials
designed to evaluate momelotinib among patients with primary
myelofibrosis, post-polycythemia vera myelofibrosis or
post-essential thrombocythemia myelofibrosis. In SIMPLIFY-1, a
double-blind, active-controlled study, 432 myelofibrosis patients
who had not previously been treated with a JAK inhibitor were
randomized (1:1) to receive momelotinib or ruxolitinib for 24
weeks. In SIMPLIFY-2, 156 patients previously treated with, but not
refractory to, ruxolitinib were randomized (2:1) to receive
momelotinib or BAT for 24 weeks.
The primary efficacy endpoint of both studies was SRR24, defined
as the proportion of patients achieving a ≥ 35 percent reduction in
spleen volume at Week 24 as measured by magnetic resonance imaging
(MRI) or computerized tomography (CT) scan. Secondary endpoints
included response rate in TSS at Week 24 (the proportion of
patients achieving ≥ 50 percent reduction in symptoms, as measured
by the modified Myeloproliferative Neoplasm Symptom Assessment Form
Total Symptom Score diary), the proportion of patients who are
transfusion-independent at Week 24 (defined as no red blood cell
transfusion and no hemoglobin level below 8 g/dL in the prior 12
weeks); the proportion who are transfusion-dependent at Week 24
(defined as at least four units of red blood cell transfusion or
hemoglobin level below 8 g/dL in the prior eight weeks), and the
rate of red blood cell transfusion through Week 24.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that
discovers, develops and commercializes innovative therapeutics in
areas of unmet medical need. The company’s mission is to advance
the care of patients suffering from life-threatening diseases.
Gilead has operations in more than 30 countries worldwide, with
headquarters in Foster City, California.
Forward-Looking
Statement
This press release includes forward-looking statements, within
the meaning of the Private Securities Litigation Reform Act of
1995, that are subject to risks, uncertainties and other factors,
including the risk that Gilead may be unable to submit regulatory
applications for momelotinib in the currently anticipated
timelines. In addition, the regulatory filings may not be approved
by the regulatory authorities, and marketing approvals, if granted,
may have significant limitations on their use. As a result,
momelotinib may never be successfully commercialized. These risks,
uncertainties and other factors could cause actual results to
differ materially from those referred to in the forward-looking
statements. The reader is cautioned not to rely on these
forward-looking statements. These and other risks are described in
detail in Gilead’s Quarterly Report on Form 10-Q for the quarter
ended September 30, 2016, as filed with the U.S.
Securities and Exchange Commission. All forward-looking statements
are based on information currently available to Gilead, and Gilead
assumes no obligation to update any such forward-looking
statement.
For more information on Gilead Sciences,
please visit the company’s website at www.gilead.com, follow
Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs
at 1-800-GILEAD-5 or 1-650-574-3000.
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