BOULDER, Colo., May 18, 2016 /PRNewswire/ -- Array BioPharma
(NASDAQ: ARRY) will present additional data on its late-stage
candidates binimetinib and encorafenib in NRAS-mutant
melanoma and BRAF-mutant colorectal cancer, respectively, at
the 2016 American Society of Clinical Oncology (ASCO) Annual
Meeting in Chicago, Illinois on
June 3-7.
"We look forward to presenting data at ASCO from our pivotal
NEMO trial of binimetinib in NRAS-mutant melanoma, which met
its primary endpoint of progression free survival (PFS), and plan
to submit a New Drug Application (NDA) for binimetinib next month,"
said Ron Squarer, Chief Executive Officer of Array BioPharma.
"Importantly, in the pre-specified sub-group of patients who
received prior treatment with immunotherapy, including ipilimumab
and nivolumab, median PFS was 5.5 months for patients treated with
binimetinib compared to 1.6 months for patients treated with
dacarbazine. These results are encouraging given the limited
treatment options available to patients with NRAS-mutant
melanoma beyond immunotherapy."
"We are also pleased to share results from our Phase 2 trial of
encorafenib and cetuximab containing-regimens in BRAF-mutant
colorectal cancer patients who have progressed after one or more
prior therapies," added Mr. Squarer. "Data from this study suggest
that median overall survival (OS) for these patients may exceed one
year which is substantial when compared to historical published
benchmarks for this population, which range between four to six
months. We expect to present updated OS data from this trial at
ASCO and plan to initiate a global Phase 3 trial in
BRAF-mutant colorectal cancer later this year."
BINIMETINIB
In the Phase 3 NEMO (NRAS MELANOMA AND
MEK INHBITOR) trial, 402 patients with
NRAS-mutant melanoma were randomized 2:1 to receive
binimetinib or dacarbazine, respectively. Eighty-five of the 402
patients received prior treatment with immunotherapy.
- The primary endpoint of PFS was met, with a hazard ratio of
0.62, [95% CI 0.47-0.80] and a p-value of less than 0.001. The
median PFS on the binimetinib arm was 2.8 months versus 1.5 months
on the dacarbazine arm.
- Importantly, an improvement in median PFS in
binimetinib-treated patients was observed in the pre-specified
sub-group of patients who received prior treatment with
immunotherapy. The median PFS on the binimetinib arm was 5.5 months
versus 1.6 months on the dacarbazine arm [HR=0.46 (95% CI
0.26-0.81)].
- Confirmed overall response rate (ORR) and disease control rate
(DCR) were 15 percent (95% CI, 11-20 percent) and 58 percent (95%
CI, 52-64 percent) for all patients receiving binimetinib,
respectively, versus 7 percent (95% CI, 3-13 percent) and 25
percent (95% CI, 18-33 percent) for patients receiving dacarbazine,
respectively.
- Grade 3/4 adverse events (AEs) reported in greater than or
equal to 5 percent of patients receiving binimetinib included
increased creatine phosphokinase (CPK) and hypertension.
- Array expects to present additional OS data at ASCO.
Data from the Phase 3 study will be featured during an oral
presentation on Monday, June 6,
1:15 p.m. CT:
- Abstract 9500: Results of NEMO: A phase III trial of
binimetinib (BINI) vs dacarbazine (DTIC) in NRAS-mutant
cutaneous melanoma
- Presenter: Reinhard
Dummer, M.D.
ENCORAFENIB
In the Phase 2 BRAF-mutant colorectal cancer trial, 102
patients were randomized 1:1 to receive encorafenib and cetuximab
with or without alpelisib:
- Median PFS was 5.4 months and 4.2 months for the triplet and
doublet regimens, respectively.
- An early analysis of median OS exceeded one year for the
triplet regimen and was not reached for the doublet regimen.
Updated interim median OS analysis for both regimens will be
presented at ASCO.
- Confirmed ORR was 27 percent (95% CI, 16-41 percent) for the
triplet regimen and 22 percent (95% CI, 12-36 percent) for the
doublet regimen.
- Grade 3/4 AEs occurring in greater than 10 percent of patients
in either arm included anemia, hyperglycemia and increased
lipase.
Historical published PFS and OS results after first-line
treatment range between 1.8 to 2.5 months and four to six months,
respectively, and published response rates from various studies in
this population range between 6 percent to 8 percent.
Data from the Phase 2 study will be presented on Saturday, June 4, 8:00 -
11:30 a.m. CT:
- Abstract 3544: Phase 2 results: encorafenib (ENCO) and
cetuximab (CETUX) with or without alpelisib (ALP) in patients with
advanced BRAF-mutant colorectal cancer (BRAFm CRC)
- Presenter: Josep
Tabernero, M.D., Ph.D.
Additional data from Array BioPharma and partner compounds will
also be presented at ASCO across a variety of tumor types.
All abstracts can be accessed through the ASCO website,
http://abstract.asco.org/. After the presentations and posters
are public, they will be available as PDFs on Array's website at
www.arraybiopharma.com.
About NRAS-Mutant Melanoma
Activating
NRAS mutations are present in up to 20 percent of patients
with metastatic melanoma, and is a poor prognostic indicator for
these patients. Treatment options for this population remain
limited beyond immunotherapy, and patients face poor clinical
outcomes and high mortality.
About BRAF-Mutant Colorectal Cancer
Colorectal
cancer is the third most common cancer among men and women in
the United States, with more than
134,000 new cases and nearly 50,000 deaths from the disease
projected in 2016.
About Binimetinib and Encorafenib
MEK and BRAF 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, such as melanoma,
non-small cell lung, colorectal and thyroid cancers. Binimetinib is
a late-stage small molecule MEK inhibitor and encorafenib is a
late-stage small molecule BRAF inhibitor, both of which target key
enzymes in this pathway.
Binimetinib and encorafenib are being studied in Phase 3 trials
in advanced cancer patients, including: NRAS-mutant melanoma
(NEMO, binimetinib single agent) and BRAF-mutant melanoma in
combination with encorafenib (COLUMBUS, binimetinib and
encorafenib). Activating BRAF mutations are present in
approximately 50 percent of patients with metastatic melanoma.
NRAS-mutant melanoma represents the first potential
indication for binimetinib, with a projected regulatory filing
estimated in the first half of 2016. Array also projects COLUMBUS
top-line results availability during the third quarter of 2016. In
addition, Array plans to initiate a Phase 3 global registration
trial in patient with BRAF-mutant colorectal cancer 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. Five registration studies are
currently advancing related to three cancer drugs. These programs
include binimetinib (MEK162), encorafenib (LGX818) 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 and our partnered programs, the timing
of the completion or initiation of further development of our
wholly-owned and our partnered programs, including the timing of
regulatory filings, expectations that events will occur that will
result in greater value for Array, the potential for the results of
ongoing preclinical and clinical trials to support regulatory
approval or the marketing success of a drug candidate, and our
future plans to progress and develop our proprietary programs.
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 continue to fund and
successfully progress internal research and development efforts and
to create effective, commercially-viable drugs; 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 May 18, 2016.
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:
|
Tricia
Haugeto
|
|
(303)
386-1193
|
|
thaugeto@arraybiopharma.com
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