BOULDER, Colo., Dec. 16, 2015 /PRNewswire/ -- Array
BioPharma (Nasdaq: ARRY) today reported top-line results from the
ongoing Phase 3 clinical trial of binimetinib in patients with
advanced NRAS-mutant melanoma, known as the NEMO trial. The
study met its primary endpoint of improving progression-free
survival (PFS) compared with dacarbazine treatment. The median PFS
on the binimetinib arm was 2.8 months versus 1.5 months on the
dacarbazine arm; hazard ratio (HR) 0.62, [95% CI 0.47-0.80], p <
0.001.
In the trial, binimetinib was generally well-tolerated and the
adverse events reported were consistent with previous results in
NRAS melanoma patients.
Array plans to submit binimetinib to regulatory authorities for
marketing approval in NRAS-mutant melanoma during the first half of
2016. Results from the NEMO trial including progression free
survival, overall survival, objective response rate, safety and
prespecified subgroup analyses including outcomes in patients who
received prior treatment with immunotherapy will be presented at a
medical meeting in 2016.
"We are excited to announce positive results from the NEMO
trial, which suggest binimetinib has the potential to provide an
important new treatment option for patients with advanced NRAS
melanoma," said Ron Squarer, Chief Executive Officer, Array
BioPharma. "We look forward to discussing the data with the
FDA and other regulatory agencies in the near future."
"The presence of an NRAS mutation is a poor prognostic indicator
for patients with advanced melanoma," said Keith T. Flaherty, M.D., Associate Professor,
Medicine, Harvard Medical School and
Director of Developmental Therapeutics, Cancer Center,
Massachusetts General Hospital. "I am encouraged the NEMO
trial met its primary endpoint and look forward to sharing the full
results soon. As the first targeted therapy with positive
results in NRAS melanoma, binimetinib will be a welcome addition in
this high unmet need population, especially for patients whose
disease has progressed following treatment with immunotherapy."
Binimetinib is also being studied in the Phase 3 COLUMBUS trial
for patients with BRAF-mutant melanoma and the Phase 3 MILO trial
for patients with low grade serous ovarian cancer, as well as in
several other earlier stage clinical trials.
About NEMO
The NEMO trial, (NCT01763164), is an international, randomized
Phase 3 study in patients with advanced NRAS-mutant melanoma.
402 patients were randomized 2:1 to receive continuous 45 mg BID
binimetinib or 1,000 mg/m2 dacarbazine dosed every three
weeks. Prior immunotherapy treatment was allowed. The
primary endpoint of the study is progression free survival, and
overall survival is a key secondary endpoint. Patients
underwent radiographic assessment of disease status every six
weeks, and assessment of progression was determined by blinded
central review. Over 100 sites across North America, Europe, South
America, Asia and
Australia participated in the
study.
About Binimetinib
MEK is a key protein kinase in the RAS/RAF/MEK/ERK pathway.
Research has shown this pathway regulates several key cellular
activities including proliferation, differentiation, migration,
survival and angiogenesis. Inappropriate activation of proteins in
this pathway has been shown to occur in many cancers, such as
non-small cell lung cancer, melanoma, colorectal, ovarian and
thyroid cancers. Binimetinib is a small molecule MEK inhibitor
which targets key enzymes in this pathway. Binimetinib is
being studied in three active Phase 3 trials in advanced cancer
patients, including: NRAS-mutant melanoma (NEMO), low-grade serous
ovarian cancer (MILO) and BRAF-mutant melanoma (COLUMBUS).
About NRAS Melanoma
Melanoma is the fifth most common cancer among men and the
seventh most common cancer among women in the United States, with almost 74,000 new
cases and nearly 10,000 deaths from the disease projected in 2015.
NRAS mutations occur in approximately 15% to 20% of patients with
melanoma, and is known to be a poor prognostic factor. When
melanoma is diagnosed early, it is generally a curable disease.
However, when it spreads to other parts of the body, it is the
deadliest and most aggressive form of skin cancer. Historically, a
person with metastatic melanoma typically has a short life
expectancy with NRAS melanoma patients living an average of 8.5
months from diagnosis.
About Array BioPharma
Array BioPharma Inc. is a biopharmaceutical company focused on
the discovery, development and commercialization of targeted small
molecule drugs to treat patients afflicted with cancer. Six
registration studies are currently advancing related to three
cancer drugs. These programs include binimetinib (MEK162),
encorafenib (LGX818) and selumetinib (AstraZeneca). For more
information on Array, please go to www.arraybiopharma.com.
Forward-Looking Statement
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, including statements about the future development plans of
binimetinib and the timing of the announcement of further results
of clinical trials for binimetinib; expectations that events will
occur that will result in greater value for Array; and the
potential for the results of current and further clinical trials to
support regulatory approval or the marketing success of
binimetinib. These statements involve significant risks and
uncertainties, including those discussed in our most recent annual
report filed on Form 10-K, in our quarterly reports filed on Form
10-Q, and in other reports filed by Array with the Securities and
Exchange Commission. Because these statements reflect our current
expectations concerning future events, our actual results could
differ materially from those anticipated in these forward-looking
statements as a result of many factors. These factors include, but
are not limited to, the determination by the FDA that results from
clinical trials are not sufficient to support registration or
marketing approval of binimetinib; our ability to effectively and
timely conduct clinical trials in light of increasing costs and
difficulties in locating appropriate trial sites and in enrolling
patients who meet the criteria for certain clinical trials; risks
associated with our dependence on third-party service providers to
successfully conduct clinical trials within and outside
the United States; our ability to
achieve and maintain profitability and maintain sufficient cash
resources; and our ability to attract and retain experienced
scientists and management. We are providing this information as of
December 16, 2015. We undertake no
duty to update any forward-looking statements to reflect the
occurrence of events or circumstances after the date of such
statements or of anticipated or unanticipated events that alter any
assumptions underlying such statements.
CONTACT:
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Tricia
Haugeto
|
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(303)
386-1193
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thaugeto@arraybiopharma.com
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