BOULDER, Colo., Sep 30, 2011 (BUSINESS WIRE) --
Array BioPharma Inc. (NASDAQ: ARRY) today announced results from a
randomized Phase 2 placebo-controlled study conducted by AstraZeneca
comparing the efficacy of selumetinib (AZD6244/ARRY-886) in combination
with docetaxel with docetaxel alone in the second-line treatment of 87
patients prospectively selected with KRAS-mutant, locally advanced or
metastatic non-small cell lung cancer. This was the first completed
randomized combination trial with a MEK inhibitor. Selumetinib was
licensed from Array to AstraZeneca.
The study's primary endpoint of overall survival demonstrated a
numerically greater increase in survival in favor of selumetinib in
combination with docetaxel versus docetaxel alone, but did not reach
The key secondary endpoints of progression-free survival, objective
response rate, and alive and progression-free at 6 months were all
demonstrated with statistical significance, showing improvement in favor
of selumetinib in combination with docetaxel versus docetaxel alone.
Further data and analyses will be presented by the study's academic
investigators at a forthcoming scientific conference.
About Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer (NSCLC) is one of the leading causes of
cancer-related mortality in the U.S. In 2011, the estimated new cases
of NSCLC in the U.S. are 186,000. Most patients are diagnosed with
advanced, stage IIIb or IV disease and are not amenable to surgery.
The overall two-year survival rate for patients with advanced NSCLC is
In patients with NSCLC, major components of cell signaling pathways,
such as the Ras-Raf-MEK-MAPK pathway, and components of the normal
cell cycle are frequently altered. Approximately 20% of current NSCLC
patients have tumors with KRAS mutations, which represents a
sub-population of nearly 60,000 NSCLC patients in the U.S. with poor
prognosis and a high unmet medical need.
Selumetinib is an anti-cancer drug in Phase 2 development in a range of
tumors. It is a small molecule MEK inhibitor that targets a key position
in the Ras-Raf-MEK-ERK signaling pathway. MEK has been shown to be
frequently activated in cancer, in particular in tumors that have
mutations in the RAS and RAF pathways.
AstraZeneca is also completing a Phase 2 trial with selumetinib in
combination with dacarbazine compared with dacarbazine alone as
first-line treatment of patients with melanoma whose tumors harbor BRAF
mutations. This trial completed enrollment of 91 patients in March 2010
with the primary endpoint of overall survival. There are over 45
on-going or completed Phase 1 or 2 trials with selumetinib.
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 and inflammatory diseases.
Our proprietary drug development pipeline includes clinical candidates
that are designed to regulate therapeutically important target proteins
and are aimed at significant unmet medical needs. For more information
on Array, please go to www.arraybiopharma.com.
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 completion or initiation of
further trials involving selumetinib, the potential for the results of
ongoing clinical trials to support regulatory approval or the marketing
success of selumetinib, and our future plans to progress and develop
selumetinib. These statements involve significant risks and
uncertainties, including those discussed in the most recent annual
report filed on form 10-K, quarterly reports filed on Form 10-Q, and
other reports filed by Array with the Securities and Exchange
Commission. Because these statements reflect current expectations
concerning future events, 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 ability
of AstraZeneca to continue to fund and successfully progress research
and development efforts with respect to selumetinib; risks associated
with dependence on collaborators for the clinical development and
commercialization of out-licensed drug candidates, including
selumetinib; the 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; and risks associated with dependence on
third-party service providers to successfully conduct clinical trials
within and outside the United States. Array is providing this
information as of September 30, 2011 and 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
SOURCE: Array BioPharma Inc.
Array BioPharma Inc.
Tricia Haugeto, 303-386-1193