BOULDER, Colo., Jan. 16, 2018 /PRNewswire/ -- Array
BioPharma Inc. (Nasdaq: ARRY) today announced the upcoming
presentation of updated safety results and clinical activity from
the safety lead-in of the Phase 3 BEACON CRC trial evaluating the
triplet combination of encorafenib, a BRAF inhibitor, binimetinib,
a MEK inhibitor and cetuximab, an anti-EGFR antibody, in patients
with BRAF-mutant colorectal cancer (CRC). These data will be
presented at the 2018 Gastrointestinal Cancers Symposium (ASCO GI)
in San Francisco,
California.
BEACON CRC SAFETY LEAD-IN
Title:
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Abstract #627:
BEACON CRC Study Safety Lead-in (SLI) in Patients With
BRAFV600E Metastatic Colorectal Cancer (mCRC):
Efficacy and Tumor Markers
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Presenter:
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Eric Van Cutsem,
M.D., University Hospitals Gasthuisberg Leuven and KU Leuven,
Leuven, Belgium
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Date:
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Saturday, January
20
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Times:
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7:00 am - 7:55 am PT
and 12:30 pm - 2:00 pm PT
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Updated data on the safety and tolerability profile of the
triplet combination and measures of efficacy, including mPFS, ORR,
duration of response, as well as tumor marker data, will be
available as part of the presentation on January 20. The presentation will be available as
a PDF from the Publications section of the Array website starting
January 20.
Array's BEACON CRC Phase 3 trial safety lead-in abstract
published on January 16 contains
previously presented safety and clinical activity data, as well as
new data on changes in tumor markers.
About Encorafenib and Binimetinib
BRAF and MEK are
key protein kinases in the MAPK signaling pathway
(RAS-RAF-MEK-ERK). Research has shown this pathway regulates
several key cellular activities including proliferation,
differentiation, survival and angiogenesis. Inappropriate
activation of proteins in this pathway has been shown to occur in
many cancers, including melanoma and colorectal cancer. Encorafenib
is a late-stage small molecule BRAF inhibitor and binimetinib is a
late-stage small molecule MEK inhibitor, both of which target key
enzymes in this pathway. Encorafenib and binimetinib are being
studied in clinical trials in advanced cancer patients, including
the Phase 3 BEACON CRC trial and the Phase 3 COLUMBUS trial.
The U.S. Food and Drug Administration (FDA) is currently
reviewing the New Drug Applications (NDAs) to support use of the
combination of encorafenib and binimetinib for the treatment of
patients with BRAF-mutant advanced, unresectable or
metastatic melanoma. The FDA set a target action date under the
Prescription Drug User Fee Act (PDUFA) of June 30, 2018 for both applications. In
addition, the European Medicines Agency (EMA) is reviewing the
Marketing Authorization Applications for encorafenib and
binimetininb.
Encorafenib and binimetinib are investigational medicines and
are not currently approved in any country.
Array BioPharma has exclusive rights to encorafenib and
binimetinib in the U.S. and Canada. Array has granted Ono
Pharmaceutical exclusive rights to commercialize both products in
Japan and South Korea and Pierre
Fabre exclusive rights to commercialize both products in all
other countries, including Europe,
Asia and Latin America. The
BEACON CRC trial is being conducted with support from Pierre Fabre and Merck KGaA, Darmstadt,
Germany (support is for sites
outside of North America).
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. Nine registration studies are
currently advancing related to seven Array-owned or partnered
drugs: encorafenib (LGX818), binimetinib (MEK162), selumetinib
(partnered with AstraZeneca), danoprevir (partnered with Roche),
ipatasertib (partnered with Genentech), larotrectinib (partnered
with Loxo Oncology) and tucatinib (partnered with Cascadian
Therapeutics).
Array BioPharma 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 encorafenib and
binimetinib; expectations regarding approval of encorafenib and
binimetinib for BRAF-mutant melanoma; 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
encorafenib and binimetinib. Specifically, there is no assurance
that results from the BEACON CRC trial will satisfy the
requirements of regulatory authorities necessary to file an
application for marketing approval, or that if such application is
accepted, that it will be approved. 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, EMA or other regulatory agencies that
results from clinical trials are not sufficient to support
registration or marketing approval of encorafenib and 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 and to manufacture drug substance and product within and
outside the United States; our
ability to grow and successfully develop commercialization
capabilities; 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 January 16, 2018.
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.
CONTACTS:
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Array
BioPharma
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Andrea N. Flynn,
Ph.D.
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Senior Director,
Investor Relations & Corporate Communications
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Tricia
Haugeto
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Director, Corporate
Communications & Investor
Relations
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(303)
381-6600
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ir@arraybiopharma.com
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