BOULDER, Colo., July 6, 2015 /PRNewswire/ -- Array BioPharma's
(NASDAQ: ARRY) wholly-owned RAF inhibitor, encorafenib, was
showcased this past weekend at the 2015 ESMO World Congress of
Gastrointestinal Cancer during an oral presentation. At the
meeting, data were shared from a Phase 1b trial and preliminary
data from a 100-patient randomized Phase 2 expansion of that trial
testing the combination of encorafenib and cetuximab, an EGFR
inhibitor, with or without the addition of alpelisib (BYL719)
1, an investigational PI3K inhibitor in patients with
BRAF-mutant colorectal cancer (BRAFmut CRC). Results from the
study indicate that these combinations can be administered with
good tolerability and show promising clinical activity in this
patient population with high unmet medical needs. Patient
enrollment is now complete in the Phase 2 study.
The preliminary Phase 2 results show an objective response rate
(complete or partial response) and disease control rate (complete
or partial response or stable disease) of 29% and 81%,
respectively, for patients receiving the combination of encorafenib
and cetuximab (encorafenib doublet), and 35% and 79%, respectively,
for patients receiving the combination of encorafenib, cetuximab
and alpelisib (encorafenib triplet).
Across both the encorafenib doublet and triplet treatment
groups, most treatment related adverse events were grade 1 or 2
with few grade 3 or 4 adverse events. The most frequent
treatment related adverse events across all grades for the
encorafenib doublet were fatigue (36%), nausea (31%), lipase
increased (24%), diarrhea (21%) and decreased appetite (21%), while
for the encorafenib triplet they were diarrhea (39%), nausea (37%),
fatigue (33%) and hyperglycemia (31%).
These results are consistent with the Phase 1b portion of the
trial and are encouraging when compared to currently available
therapies for BRAFmut CRC patients, as well as with other recently
published investigational approaches in this population.
Historically, response rates are very low for either single-agent
EGFR or RAF inhibitor therapy in patients with BRAFmut CRC, which
suggests a synergistic effect for the combination of encorafenib
and cetuximab in this population.
"The combination of encorafenib and cetuximab demonstrated
promising activity in this hard-to-treat subset of colorectal
cancer patients," said Josep
Tabernero, M.D., Head of the Medical Oncology Department at
the Vall d'Hebron University Hospital and the Director of the Vall
d'Hebron Institute of Oncology. "It is critical to identify new,
effective treatments for BRAF mutant colorectal cancer patients,
and I look forward to rapid development of this combination in a
subsequent clinical trial."
1 alpelisib (BYL719) is an investigational Novartis
Pharmaceuticals compound.
About Colorectal Cancer
Colorectal cancer is the
third most common cancer among men and women in the United States, with approximately 132,000
new cases and nearly 50,000 deaths from the disease projected in
2015. BRAF mutations occur in approximately 10% percent of
patients with colorectal cancer and predict for a poor response to
standard therapies and an overall poorer prognosis relative to
patients without these mutations.
About RAF and encorafenib
RAF is a key protein
kinase in the MAPK signaling pathway that regulates several key
cellular activities including proliferation, migration, survival
and angiogenesis. Inappropriate activation of this pathway has been
shown to occur in many cancers, such as melanoma, colorectal, lung
and thyroid cancers. Encorafenib is a selective, small
molecule, oral inhibitor which targets the RAF enzyme in this
pathway. It is currently being developed in eleven active clinical
trials, including the COLUMBUS trial, a Phase 3 study of
encorafenib and binimetinib (MEK inhibitor) for patients with BRAF
mutant melanoma. Array expects updated BRAF melanoma data from the
Phase 2 combination trial (LOGIC-2) of binimetinib, encorafenib and
a third agent (LEE011, BKM120, BFJ398 or INC280) will be submitted
to a scientific conference later this year.
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
encorafenib, expectations that events will occur that will result
in greater value for Array, the potential for the results of
ongoing clinical trials to support regulatory approval or the
marketing success of encorafenib, and our future plans to progress
and develop encorafenib. 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
July 6, 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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SOURCE Array BioPharma