BOULDER, Colo., Sept. 14, 2016 /PRNewswire/ -- Array
BioPharma (Nasdaq: ARRY) announced today that it has reached
agreement with the U.S. Food and Drug Administration (FDA)
regarding a Special Protocol Assessment (SPA) related to BEACON
CRC, a global Phase 3 trial of encorafenib and Erbitux®
(cetuximab), with or without binimetinib, versus standard of care
in patients with BRAF-mutant colorectal cancer (CRC) who
have previously received first-or second-line systemic
therapy.
"Colorectal cancer is the third most common cancer among men and
women in the United States and
BRAF-mutant CRC represents a high unmet medical need, as
there are currently no targeted treatment options available for
patients with this form of the disease," said Scott Kopetz, M.D., Ph.D., of the University of Texas MD Anderson Cancer Center in
Houston and BEACON CRC
investigator. "The SPA agreement between Array and the FDA
represents a welcome next step for the CRC community and, as a
physician, I look forward to exploring these novel treatment
combinations."
The SPA provides agreement that the design and planned analysis
of BEACON CRC adequately address the objectives necessary to
support a regulatory submission for the approval of the doublet
regimen of encorafenib and Erbitux®. The FDA also
communicated that sharing evidence from the study that the triplet
regimen (encorafenib, Erbitux and binimetinib) both met its primary
endpoint (Overall Survival) as compared to the control arm, and
demonstrated a clinically meaningful benefit as compared to the
doublet regimen, would provide support for approval of the triplet
regimen.
Trial Design
BEACON CRC is a randomized, open-label, global study evaluating
the efficacy and safety of encorafenib and Erbitux, with or without
binimetinib, in patients with BRAF-mutant metastatic CRC who
have previously received first-or second-line systemic therapy. The
study includes a safety lead-in with approximately 30
patients. With appropriate results from the lead-in,
approximately 615 patients are expected to be randomized 1:1:1 to
receive triplet therapy (encorafenib, Erbitux and binimetinib),
doublet therapy (encorafenib and Erbitux) or the control arm
(irinotecan-based therapy and Erbitux). The primary endpoint
of the trial is OS of the triplet therapy compared to the control
arm. Secondary endpoints address efficacy of the doublet therapy
compared to the control arm, and the triplet therapy compared to
the doublet therapy. Other secondary endpoints include
progression-free survival (PFS), objective response rate (ORR),
duration of response, safety and tolerability. Health related
quality of life data will also be assessed.
Array is conducting BEACON CRC in partnership with Pierre Fabre and Merck KGaA, Darmstadt,
Germany at over 250
investigational sites in North
America, South America,
Europe and the Asia Pacific region. Patient enrollment is
expected to be completed in 2018.
About BRAF-mutant Metastatic 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. In the United States, BRAF mutations occur
in 8 to 15 percent of patients with colorectal cancer and represent
a poor prognosis for these patients. Historical published PFS and
OS results after first-line treatment range from 1.8 to 2.5 months
and 4 to 6 months, respectively, and published response rates from
various studies for EGFR-based therapy in this population range
from 6 percent to 8 percent.
About Binimetinib & 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, 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 the COLUMBUS trial studying
encorafenib and binimetinib in combination in patients with
BRAF-mutant melanoma and the recently initiated BEACON CRC
trial that will study encorafenib in combination with Erbitux, with
or without binimetinib, in patients with BRAF V600E-mutant
colorectal cancer. On September 1,
2016, Array announced that the FDA has accepted its New Drug
Application (NDA) for binimetinib with a target action date under
the Prescription Drug User Fee Act (PDUFA) of June 30, 2017. Array completed its NDA
submission of binimetinib in late June
2016 based on findings from the pivotal Phase 3 NEMO trial
in patients with NRAS-mutant melanoma.
About a Special Protocol Assessment
A Special Protocol
Assessment (SPA) is a process by which sponsors ask the FDA to
evaluate a protocol to determine whether it adequately addresses
scientific and regulatory requirements for the purpose identified
by the sponsor. A SPA agreement indicates concurrence with the
adequacy and acceptability of specific critical elements of
protocol design and analysis. To review the FDA's complete
SPA guidance, please click the following link:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM498793.pdf
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 expectations that events will
occur that will result in greater value for Array, the potential
for the results of the BEACON CRC trial will support regulatory
approval or the marketing success of the drug candidate, the timing
for completion of patient enrollment, expectations regarding
regulatory requirements for approval and our plans to build a
late-stage development company. 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 the BEACON CRC trial;
risks relating to the regulatory approval process, which may not
result in approval for our drug candidates, cause delays in
development or require that we expend more resources to obtain
approval than expected; our ability to effectively and timely
conduct the BEACON CRC trial in light of increasing costs and
difficulties in locating appropriate trial sites and in enrolling
patients who meet the enrollment criteria; 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 September 14, 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:
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Tricia
Haugeto
|
|
(303)
386-1193
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|
thaugeto@arraybiopharma.com
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