BOULDER, Colo., June 1, 2015 /PRNewswire/ -- Array BioPharma's
(NASDAQ: ARRY) wholly-owned MEK inhibitor, binimetinib, and BRAF
inhibitor, encorafenib, were showcased at the 2015 annual meeting
of the American Society of Clinical Oncology (ASCO). At the
meeting, preliminary data for the combination of binimetinib and
encorafenib from a Phase 1b/2 dose escalation and expansion study
in patients with BRAF-mutant melanoma who are BRAF inhibitor
treatment naive were shared during an oral presentation. Results
from the study indicate that binimetinib and encorafenib may be
safely combined and show encouraging clinical activity consistent
with MEK/BRAF inhibitor expectations in patients with BRAF-mutant
melanoma who are BRAF inhibitor treatment naive. In addition, a
differentiated safety profile relative to other MEK/BRAF inhibitor
combinations is emerging in the dose range currently being used in
the Phase 3 COLUMBUS trial. Array expects updated BRAF
melanoma data from the ongoing Phase 2 combination trial (LOGIC-2)
of binimetinib and encorafenib followed by the addition of a third
targeted agent identified based on genetic testing at the time of
progression will be submitted to a scientific conference later this
year. LOGIC-2 utilizes the same dose of binimetinib and
encorafenib currently being studied in the COLUMBUS trial.
In the study, patients were treated with binimetinib 45 mg twice
daily (BID) and increasing doses of encorafenib once daily (QD)
(over the range of 50 to 800 mg and including doses of 400 and 450
mg, which are comparable to the 450 mg dose being used in the Phase
3 COLUMBUS trial), followed by an expansion phase at the maximum
tolerated dose of 600 mg QD. The objective response rate
(confirmed complete response or partial response) reported in the
trial was 75 percent (41 of 55) for BRAF-naive patients, including
78 percent (7 of 9) of patients treated with the encorafenib
400/450 mg dose. The estimated median overall progression-free
survival for BRAF-naive patients was 11.3 months. These results are
consistent with MEK/RAF inhibitor expectations in BRAF-mutant
melanoma patients.
Preliminary data from the study also indicate that in
combination with binimetinib, encorafenib was tolerated at doses up
to 600 mg, twice its single-agent maximum tolerated dose. At
the 400/450 mg dose of encorafenib, with few grade 3 / 4 events and
an 11 percent incidence of pyrexia and photosensitivity, a
differentiated safety profile relative to other MEK/BRAF inhibitor
combinations is emerging.
"The combination of BRAF and MEK inhibitors is now established
as the optimal molecularly targeted therapy for BRAF mutant
melanoma patients," said Ryan
Sullivan, M.D., investigator, Massachusetts General Hospital
Cancer Center, Boston. "In this
study, the combination of encorafenib and binimetinib demonstrated
excellent clinical activity, consistent with other BRAF/MEK
inhibitor combinations, and an encouraging toxicity profile."
About 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.
BRAF mutations occur in approximately 50 percent of patients with
melanoma. 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.
A person with metastatic melanoma typically has a short life
expectancy with only approximately 15 percent of patients
surviving for five years following diagnosis of metastatic
disease.
About BRAF, MEK, Binimetinib and Encorafenib
Raf and MEK are key protein kinases in the RAS/RAF/MEK/ERK
pathway, which regulates several key cellular activities including
proliferation, differentiation, migration, survival and
angiogenesis. Inappropriate activation of this pathway has been
shown to occur in many cancers, such as melanoma, colorectal and
thyroid cancers. Binimetinib is a small molecule MEK inhibitor
and encorafenib is a small molecule BRAF inhibitor, both of which
target key enzymes in this pathway. Three Phase 3 trials in
advanced cancer patients continue to advance: NRAS-mutant melanoma
(NEMO, with binimetinib), low-grade serous ovarian cancer (MILO,
with binimetinib) and BRAF-mutant melanoma (COLUMBUS, with
binimetinib and encorafenib). The NEMO and COLUMBUS Part 1 studies
completed enrollment in April 2015.
NRAS-mutant melanoma represents the first potential indication for
binimetinib, with a projected regulatory filing estimated in the
first half of 2016. Array also projects a regulatory filing of
binimetinib in combination with encorafenib in BRAF melanoma in
2016.
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 Phase 3
studies are currently advancing. These programs include three
cancer drugs, binimetinib (MEK162 / wholly-owned), encorafenib
(LGX818 / wholly-owned) 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 timing of the announcement of
the results of clinical trials for our proprietary programs, the
timing of the completion or initiation of further development of or
regulatory filings for our wholly-owned programs, expectations that
events will occur that will result in greater value for Array, the
potential for the results of ongoing preclinical and clinical
trials to support regulatory approval or the marketing success of a
drug candidate, our future plans to progress and develop our
proprietary programs, and our plans to build a late-stage
development company. 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, 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 June 1, 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: Tricia Haugeto
(303) 386-1193
thaugeto@arraybiopharma.com
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SOURCE Array BioPharma Inc.