BOULDER, Colo., and CASTRES, France, Oct. 25,
2016 /PRNewswire/ -- Array BioPharma (NASDAQ: ARRY) and
Pierre Fabre announced today that results from the Phase 3 COLUMBUS
trial of binimetinib and encorafenib in BRAF-mutant melanoma
will be presented at the 2016 Society for Melanoma Research (SMR)
Annual Congress in Boston,
Massachusetts on November 9.
Findings from COLUMBUS evaluating the combination of encorafenib
plus binimetinib ("combination") in patients with unresectable or
metastatic BRAF-mutant melanoma will be presented as an
oral, late-breaking abstract. Two data analyses from the NEMO
Phase 3 trial will also be presented, which evaluated binimetinib
in patients with NRAS-mutant melanoma.
COLUMBUS TRIAL DATA
Data from the Phase 3 study will be featured as an oral
presentation during the late-breaking abstract session on
Wednesday, November 9 from 10:00 –
10:15 AM ET:
- Abstract 2617508: Results of COLUMBUS Part 1: A Phase 3
Trial of Encorafenib (ENCO) Plus Binimetinib (BINI) Versus
Vemurafenib (VEM) or ENCO in BRAF-Mutant Melanoma
- Presenter: Keith T.
Flaherty, M.D., Director of the Termeer Center for Targeted
Therapy, Massachusetts General Hospital and Professor of Medicine,
Harvard Medical School, Boston, Massachusetts
As reported in late September, 577 patients were randomized
1:1:1 to receive the combination of encorafenib plus binimetinib,
encorafenib alone, or vemurafenib alone. In the analysis of the
primary endpoint, the median PFS for patients treated with the
combination of encorafenib plus binimetinib ("combination") was
14.9 months versus 7.3 months for patients treated with
vemurafenib; HR (0.54), [95% CI 0.41-0.71], p<0.001. Analysis of
a secondary endpoint comparing the PFS of patients treated with
combination to patients treated with encorafenib showed a median of
14.9 months versus 9.6 months with HR (0.75), [95% CI 0.56-1.00],
p=0.051, which did not reach statistical significance. The
combination was generally well-tolerated and reported adverse
events were overall consistent with previous combination
encorafenib plus binimetinib clinical trial results in
BRAF-mutant melanoma patients.
ARRAY BIOPHARMA INVESTOR RECEPTION
Array will be hosting an investor reception immediately
following the conclusion of SMR. The event will be held on
Wednesday, November 9 from 1 –
3 pm ET in Boston and will include an encore presentation
of the COLUMBUS results by Dr. Flaherty at 1
pm ET. The public is welcome to participate in the
presentation through a webcast (live and replay):
http://edge.media-server.com/m/p/jmj68buy
For questions regarding the reception, please contact
Melissa Green/ConferenceSource at
303-325-8800 or melissa@conference-source.com.
About Metastatic Melanoma
Melanoma is the fifth most
common cancer among men and the seventh most common cancer among
women in the United States, with
more than 76,000 new cases and over 10,000 deaths from the disease
expected in 2016. Novel therapies that target the RAS/RAF/MEK/ERK
pathway have a strong scientific rationale for activity in advanced
melanoma, as up to 50 percent of patients with metastatic melanoma
have activating BRAF mutations, the most common gene mutation in
this patient population. Activating NRAS mutations are
present in up to 20 percent of patients with metastatic melanoma,
and is a poor prognostic indicator for these patients.
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 clinical trials
in advanced cancer patients, including the recently initiated Phase
3 BEACON CRC trial that is evaluating encorafenib in combination
with cetuximab with or without binimetinib in patients with BRAF
V600E-mutant colorectal cancer. Array submitted a New Drug
Application (NDA) for binimetinib in NRAS-mutant melanoma to
the FDA at the end of June 2016. The
FDA accepted the NDA with a target action date under the
Prescription Drug User Fee Act (PDUFA) of June 30, 2017. Array also expects to submit
an NDA for binimetinib and encorafenib in BRAF-mutant
melanoma to the FDA in 2017.
Array BioPharma retains exclusive rights to binimetinib and
encorafenib in key markets including the U.S., Japan, Canada, Korea and Israel. Pierre Fabre will have exclusive
rights to commercialize both products in all other countries,
including Europe, Asia and Latin
America.
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
http://www.arraybiopharma.com/.
About Pierre Fabre
Pierre Fabre is a French private
pharmaceuticals and dermo-cosmetics company founded in 1962 by Mr.
Pierre Fabre. Its turnover reached over 2.2
billion Euros in 2015, spread over 130 countries. The
company is structured around two divisions: Pharmaceuticals
(prescription drugs, consumer health care) and Dermo-cosmetics
(including Pierre Fabre Dermatologie, one of the most comprehensive
portfolio of Rx dermatology worldwide, and Eau Thermale Avène, a
global market-leading brand in dermo-cosmetics). Pierre Fabre
employs some 13,000 people worldwide and owns subsidiaries in 43
countries. In 2015, the company allocated 16% of its
pharmaceuticals sales to R&D with a focus on 4 therapeutic
areas: oncology, dermatology, CNS and consumer health care.
Pierre Fabre Oncology, a business unit of the Pierre Fabre
company, is supported by over 1,000 employees with a strong focus
on European markets. In 2015, worldwide annual sales of Pierre
Fabre Oncology products surpassed $200
million on the strength of the Oral Navelbine, Javlor and
Busilvex brands.
Through the Group's controlling company Pierre Fabre
Participations, Pierre Fabre is 86% owned by the Pierre Fabre
Foundation, a recognized public-interest organization since 1999.
Up to 8% of the remaining shares are held by the company's
employees and the remaining balance is held as treasury stock.
To find out more about Pierre Fabre, please go to
www.pierre-fabre.com
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 future development plans of binimetinib and
encorafenib, and the timing of the announcement of further results
of clinical trials for binimetinib and encorafenib; expectations
regarding the timing of regulatory filings for binimetinib and
encorafenib and regarding approval of binimetinib and encorafenib
for BRAF-mutant melanoma; expectations that events will
occur that will result in greater value for Array; and the
potential for the results of current and further clinical trials to
support regulatory approval or the marketing success of binimetinib
and encorafenib. Specifically, there is no assurance that results
from the COLUMBUS study, including Parts 1 and 2, will satisfy the
requirements of regulatory authorities necessary to file an
application for marketing approval, or that if such application is
accepted, that it will be approved. 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; 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
October 25, 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.
CONTACTS:
|
Tricia
Haugeto
|
Valérie
Roucoules
|
|
(303)
386-1193
|
(33) 1 49 10 83
84
|
|
thaugeto@arraybiopharma.com
|
valerie.roucoules@pierre-fabre.com
|
Logo -
http://photos.prnewswire.com/prnh/20121029/LA02195LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/array-biopharma-and-pierre-fabre-to-present-phase-3-columbus-trial-at-society-for-melanoma-research-annual-congress-300351058.html
SOURCE Array BioPharma Inc.