BOULDER, Colo., May 8, 2017 /PRNewswire/ -- Array BioPharma
Inc. (Nasdaq: ARRY) announced
today that it has entered into a clinical trial collaboration
agreement with Merck (known as MSD outside the United States and Canada) to investigate the safety and efficacy
of Array's MEK inhibitor, binimetinib, with Merck's anti-PD-1
therapy, KEYTRUDA® (pembrolizumab), in metastatic
colorectal cancer patients with microsatellite stable tumors (MSS
CRC).
The companies are entering into this collaboration based on the
growing body of preclinical and clinical evidence that the immune
activity of an anti-PD-1 therapy, such as KEYTRUDA, can be enhanced
when combined with a MEK inhibitor, such as binimetinib.
"Array is excited to announce this partnership with Merck, an
established leader in the field of immuno-oncology," said Ron
Squarer, Chief Executive Officer, Array BioPharma. "Given the
synergistic activity we have seen with our MEK inhibitor when
combined with anti-PD-1 therapy in preclinical models, and based on
emerging clinical data, we are optimistic that this combination
holds great potential for cancer patients."
Under the terms of the agreement, Array and Merck will
collaborate on a clinical trial to investigate the safety and
efficacy of the combination of binimetinib with KEYTRUDA, in MSS
CRC patients. The trial is expected to establish a recommended dose
regimen of binimetinib and KEYTRUDA, as well as explore the
preliminary anti-tumor activity of several novel regimens. The
study is expected to begin in the second half of 2017. Results from
this first study will be used to determine optimal approaches to
further clinical development of these combinations.
The collaboration agreement is between Array BioPharma and
Merck, through a subsidiary. Under the agreement, the trial will be
sponsored by Merck. Additional details of the collaboration
were not disclosed.
About Colorectal Cancer
Worldwide, colorectal cancer
is the third most common type of cancer in men and the second most
common in women, with approximately 1.4 million new diagnoses in
2012. Of these, nearly 750,000 were diagnosed in men, and 614,000
in women. Globally in 2012, approximately 694,000 deaths were
attributed to colorectal cancer. In the U.S. alone, an estimated
135,430 patients will be diagnosed with cancer of the colon or
rectum in 2017, and approximately 50,000 are estimated to die of
their disease. There is wide variation in 5-year survival
rates across the globe, with 5-year survival expected to be around
65% in the developed world and dropping to around 20% in some
developing countries. The incidence of microsatellite stability in
colorectal tumors varies by stage, with nearly 80% of early stage,
resectable tumors and approximately 67% of advanced, metastatic
tumors exhibiting MSS.
About Binimetinib
MEK is a key protein kinase 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, such as melanoma, colorectal and thyroid
cancers. Binimetinib is a late-stage small molecule MEK inhibitor
which targets key enzymes in this pathway.
Binimetinib is being studied in clinical trials in advanced
cancer patients, including the Phase 3 COLUMBUS trial in patients
with BRAF-mutant melanoma and the Phase 3 BEACON CRC trial in
patients with BRAF V600E-mutant colorectal cancer.
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. Seven Array-owned or
partnered drugs are advancing in registration studies: binimetinib
(MEK162), encorafenib (LGX818), selumetinib (partnered with
AstraZeneca), danoprevir (partnered with Roche), larotrectinib
(partnered with Loxo Oncology), tucatinib (partnered with Cascadian
Therapeutics) and ipatasertib (partnered with Genentech).
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 timing of the commencement of the binimetinib
and KEYTRUDA clinical trial; expectations that events will occur
that will result in greater value for Array; and the potential for
the results of the planned clinical trial to support regulatory
approval or the marketing success of the combination. 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 that results from
clinical trials are not sufficient to support registration or
marketing approval of binimetinib and encorafenib; risks associated
with our dependence on third-parties 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 April 8, 2017. 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.
KEYTRUDA® is a registered trademark of Merck Sharp
& Dohme Corp., a subsidiary of Merck & Co., Inc.,
Kenilworth, NJ, USA
CONTACTS:
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Tricia
Haugeto
|
|
(303)
386-1193
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thaugeto@arraybiopharma.com
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SOURCE Array BioPharma