BOULDER, Colo.--(BUSINESS WIRE)--Jun. 4, 2012--
Promising data from a double-blind, randomized Phase 2 study conducted
by AstraZeneca comparing the efficacy of selumetinib (AZD6244/ARRY-886)
in combination with docetaxel versus docetaxel alone in 87 second-line
patients with KRAS mutation positive locally advanced or metastatic
non-small cell lung cancer (NSCLC) (Stage IIIB – IV) were presented
today at the American Society of Clinical Oncology (ASCO) Annual Meeting
in Chicago, Illinois. Array BioPharma Inc. (Nasdaq: ARRY) invented
selumetinib and licensed worldwide rights to develop selumetinib to
AstraZeneca under a collaboration agreement in 2003.
This study showed statistically significant improvement in
progression-free survival, objective response rate, and alive and
progression-free at six months as well as a trend for improvement in
overall survival in favor of selumetinib in combination with docetaxel
versus docetaxel alone.
The tolerability profile of selumetinib in combination with docetaxel
was consistent with previously conducted studies. There was an increased
incidence of Grade 3 or 4 neutropenia and febrile neutropenia and of
Grade 1 or 2 diarrhea in patients receiving the selumetinib combination
versus docetaxel alone.
Overall survival was longer for selumetinib in combination with
docetaxel compared to docetaxel alone (9.4 mo vs 5.2 mo; 56 events,
median follow-up 219 days) but did not reach statistical significance.
Hazards were non-proportional (HR 0.80; 80% CI 0.56, 1.14; 1-sided
p=0.2069). All secondary endpoints, including response rate
(selumetinib/docetaxel 37%, docetaxel 0%; p<0.0001) and progression free
survival (selumetinib/docetaxel 5.3 mo, docetaxel 2.1 mo; 71 events; HR
= 0.58; 80% CI 0.42, 0.79; 1-sided p=0.0138), were significantly
improved for selumetinib in combination with docetaxel versus docetaxel
alone.
“In the U.S., KRAS is the most prevalent oncogenic alteration in NSCLC
with approximately 20 percent of patients harboring a KRAS mutation,”
said Pasi A. Jänne, M.D., Ph.D., Primary Investigator and Associate
Professor of Medicine, Harvard Medical School. “There are no targeted
treatment options currently available for this subtype of NSCLC, so we
are extremely delighted at this stage of development to see such
promising results.”
This study is the first completed randomized combination trial with a
mitogen-activated protein kinase (MEK) inhibitor in KRAS mutant advanced
NSCLC and we believe is the first prospective study to demonstrate
clinical benefit as defined by response rate and progression-free
survival of a targeted therapy for patients with KRAS mutant cancer of
any type. Targeting MEK dependent tumors with selumetinib demonstrates
the potential of a personalized approach to medicine in the treatment of
cancer and suggests that further clinical evaluation of selumetinib in
KRAS mutation positive NSCLC patients is warranted.
About KRAS Non-Small Cell Lung Cancer
Approximately 20 to 25 percent of the NSCLC patient population has the
KRAS mutation which amounts to approximately 160,000 patients globally.
Currently, patients with KRAS NSCLC have a poor prognosis with limited
treatment options. In a prior study, docetaxel in second and third-line
treatment for KRAS positive NSCLC showed a progression free survival of
1.5 months and overall survival of 4.2 months.
About MEK and selumetinib
MEK is a key protein kinase in the RAS/RAF/MEK/ERK pathway, which
signals cancer cell proliferation and survival. MEK has been shown to be
frequently activated in cancer, in particular in tumors that have
mutations, including BRAF and NRAS, in the RAS and RAF
pathways. Selumetinib is an anti-cancer drug in Phase II development in
a range of tumors. It is a small molecule MEK inhibitor that targets a
key position in this pathway. Selumetinib was invented by Array
BioPharma Inc. (Nasdaq: ARRY) and licensed to AstraZeneca.
About lung cancer
Over 1.35 million new cases of lung cancer are diagnosed every year and
nearly 1.2 million people die as a result of this devastating disease -
more than breast, colon and prostate cancer combined. If lung cancer is
detected at early stages, before it has spread to other organs or lymph
nodes, around half of patients can survive for five years or more.
However, few lung cancers are found at this early stage and it is
normally diagnosed at the advanced stage, when five year survival falls
to approximately 15 percent.
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.
Array has four core proprietary clinical programs: ARRY-614 for
myelodysplastic syndromes, ARRY-520 for multiple myeloma, ARRY-797 for
pain and ARRY-502 for asthma. In addition, Array has 10 partner-funded
clinical programs including two MEK inhibitors in Phase 2: selumetinib
with AstraZeneca and MEK162 with Novartis. 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 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 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 June 4, 2012 and undertakes 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.
Source: Array BioPharma Inc.
Array BioPharma Inc.
Tricia Haugeto, 303-386-1193
thaugeto@arraybiopharma.com
