BOULDER, Colo., May 16, 2018 /PRNewswire/ -- Array BioPharma
Inc. (Nasdaq: ARRY) announced that it will present data from the
Phase 3 COLUMBUS trial of encorafenib and binimetinib in advanced
BRAF-mutant melanoma in an oral presentation on June 4, 2018, at the 54th Annual
Meeting of the American Society of Clinical Oncology (ASCO) in
Chicago, Illinois.
"Binimetinib and encorafenib is the first targeted therapy to
demonstrate over 30 months median overall survival in a Phase 3
trial and we look forward to presenting the results from the
COLUMBUS trial at ASCO," said Ron Squarer, Chief Executive Officer.
"With nearly 15 months median progression-free survival and an
attractive tolerability profile, these data underscore the
potential of this combination to become an important new treatment
option for patients with BRAF-mutant advanced, unresectable
or metastatic melanoma."
As previously announced, the most common Grade 3/4 adverse
events (AEs) seen in more than 5% of patients were increased
gamma-glutamyltransferase (GGT) (9%), increased creatine
phosphokinase (7%), and hypertension (6%) in the encorafenib plus
binimetinib group.
Oral
Presentation:
|
Title:
|
Overall Survival in
COLUMBUS: A Phase 3 Trial of Encorafenib (ENCO) Plus Binimetinib
(BINI) vs Vemurafenib (VEM) or ENCO in BRAF-Mutant
Melanoma
|
Presenter:
|
Reinhard Dummer,
M.D.
|
Abstract:
|
Abstract
#223875/Publication #9504
|
Session:
|
Melanoma/Skin
Cancers
|
Date:
|
Monday, June 4,
2018
|
Time:
|
9:12 a.m. - 9:24 a.m.
Central Time (10:12 a.m. – 10:24 a.m. Eastern Time)
|
Location:
|
Arie Crown
Theater
|
The abstract can be accessed through the ASCO website,
http://abstract.asco.org/, beginning May 16,
2018, at 5:00 p.m. Eastern
Time. Following the presentation on June 4, the slides will be available as a PDF on
Array's website at www.arraybiopharma.com.
Array will host an encore webcast presentation of the COLUMBUS
trial data.
Encore
Webcast:
|
Date:
|
Monday, June 4,
2018
|
Time:
|
11:15 a.m. Central
Time (12:15 p.m. Eastern Time)
|
Toll-Free:
|
(844)
464-3927
|
Toll:
|
(765)
507-2598
|
Pass
Code:
|
9615719
|
Webcast, including replay and conference call slides:
https://edge.media-server.com/m6/p/8juh6tcn
About Melanoma
Metastatic melanoma is the most serious and life-threatening type
of skin cancer and is associated with low survival rates. [1, 2]
There are about 200,000 new cases of melanoma diagnosed worldwide
each year, approximately half of which
have BRAF mutations, a key target in the treatment
of metastatic melanoma. [1, 3, 4]
About COLUMBUS
The COLUMBUS trial, (NCT01909453), is a two-part, international,
randomized, open label Phase 3 trial evaluating the efficacy and
safety of the combination of encorafenib and binimetinib compared
to vemurafenib and encorafenib monotherapy in 921 patients with
locally advanced, unresectable or metastatic melanoma
with BRAFV600 mutation. Prior
immunotherapy treatment was allowed. Over 200 sites
across North America, Europe, South
America, Africa, Asia and Australia participated
in the trial. Patients were randomized into two parts:
- In Part 1, 577 patients were randomized 1:1:1 to receive the
combination of encorafenib 450 mg daily and binimetinib 45 mg twice
daily (COMBO450), encorafenib, 300 mg daily (ENCO 300), or
vemurafenib, 960 mg twice daily alone. The dose of encorafenib in
the combination arm is 50% higher than the single agent maximum
tolerated dose of 300 mg. A higher dose of encorafenib was possible
due to improved tolerability when combined with binimetinib. The
primary endpoint for the COLUMBUS trial was an mPFS comparison of
the COMBO450 arm versus vemurafenib. mPFS is determined based on
tumor assessment (RECIST version 1.1 criteria) by a Blinded
Independent Central Review (BICR). Secondary endpoints include a
comparison of the mPFS of COMBO450 arm to that of ENCO300 and a
comparison of overall survival (OS) in patients treated in the
COMBO450 arm to that of vemurafenib alone. Results from Part 1 of
the COLUMBUS trial, previously published in The Lancet
Oncology May 2018, showed that
COMBO450 more than doubled mPFS in patients with
advanced BRAF-mutant melanoma, with a mPFS of 14.9
months compared with 7.3 months observed with vemurafenib [HR 0.54,
(95% CI 0.41-0.71, p<0.0001)]. In the secondary mPFS comparison
of COMBO450 to ENCO300, ENCO300 demonstrated a mPFS of 9.6 months
[HR 0.75, (95% CI 0.56-1.00, p=0.051)].
- In Part 2, 344 patients were randomized 3:1 to receive
encorafenib 300 mg daily plus binimetinib 45 mg twice daily
(COMBO300) or ENCO300. Part 2 was designed to provide additional
data to help evaluate the contribution of binimetinib to the
combination of encorafenib and binimetinib.
As the secondary endpoint comparison of mPFS between the
COMBO450 arm and ENCO300 arm in Part 1 did not achieve statistical
significance, the protocol specified analysis of OS is
descriptive.
About Encorafenib and Binimetinib
BRAF and MEK 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 including melanoma and colorectal cancer. Encorafenib
is a late-stage small molecule BRAF inhibitor and binimetinib is a
late-stage small molecule MEK inhibitor, both of which target key
enzymes in this pathway. Encorafenib and binimetinib are being
studied in clinical trials in advanced cancer patients, including
the Phase 3 COLUMBUS trial and the Phase 3 BEACON CRC trial.
Array BioPharma has exclusive rights to encorafenib and
binimetinib in the U.S. and Canada. Array has granted Ono Pharmaceutical
exclusive rights to commercialize both products in Japan and South
Korea and Pierre Fabre
exclusive rights to commercialize both products in all other
countries, including Europe,
Asia and Latin America. Encorafenib and binimetinib are
investigational medicines and are not currently approved in any
country.
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 other conditions. Ten
registration studies are currently advancing related to eight
Array-owned or partnered drugs: encorafenib (LGX818), binimetinib
(MEK162), ARRY-797, selumetinib (partnered with AstraZeneca),
danoprevir (partnered with Roche), ipatasertib (partnered with
Genentech), larotrectinib (partnered with Loxo Oncology) and
tucatinib (partnered with Seattle Genetics). For more information
on Array, please go to www.arraybiopharma.com.
References
[1] Melanoma Skin Cancer. American Cancer Society. Available
at: https://www.cancer.org/cancer/melanoma-skin-cancer.html.
Accessed January 2018.
[2] A Snapshot of Melanoma. National Cancer Institute.
Available
at: https://seer.cancer.gov/statfacts/html/melan.html.
Accessed January 2018.
[3] Globocan 2012: Estimated Cancer Incidence, Mortality and
Prevalence Worldwide in
2012. http://globocan.iarc.fr/Pages/fact_sheets_population.aspx.
Accessed January 2018.
[4] Klein O, et al. Eur J Cancer, 2013.
CONTACTS:
Investor Relations
Array BioPharma
Andrea N. Flynn, Ph.D.
Senior Director, Investor Relations & Corporate
Communications
(303) 381-6600
ir@arraybiopharma.com
Media
Y&R PR
Erika Hackmann, Media Relations
(917) 538-3375
erika.hackmann@yr.com
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