ARIAD Announces Initiation of Randomized, First-Line Phase 3 Trial of Brigatinib in Treatment of ALK-Positive Non-Small Cell ...
April 11 2016 - 7:35AM
Business Wire
ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) today announced the
initiation of a randomized, first-line Phase 3 clinical trial of
brigatinib, its investigational anaplastic lymphoma kinase (ALK)
inhibitor, in adult patients with ALK-positive locally advanced or
metastatic non-small cell lung cancer (NSCLC) who have not
previously been treated with an ALK inhibitor. The ALTA 1L
(ALK in Lung Cancer Trial of BrigAtinib in 1st Line) trial is designed to assess the efficacy
of brigatinib in comparison to crizotinib based on evaluation of
the primary endpoint of progression free survival (PFS).
“We are pleased to be advancing brigatinib into a pivotal Phase
3 trial as a potential new therapy for patients with ALK+ NSCLC who
have not yet received an ALK inhibitor,” said Tim Clackson, Ph.D.,
president of research and development and chief scientific officer
of ARIAD. “We believe that the encouraging results shown in our
preclinical and ongoing Phase 1/2 studies suggest brigatinib has
the potential to improve outcomes for ALK+ NSCLC patients as
compared to treatment with crizotinib.”
Trial Design
The ALTA 1L trial is a randomized, open-label, multicenter,
international study that is designed to compare the efficacy and
safety of brigatinib to crizotinib in adult patients with ALK+
NSCLC who have not previously received an ALK inhibitor. The trial
is expected to be conducted at approximately 150 investigational
sites in North America, Europe and the Asia Pacific region.
Patients in the trial must be at least 18 years of age, have stage
IIIB or stage IV NSCLC with ALK rearrangement, have received no
more than one regimen of systemic anticancer therapy in the locally
advanced or metastatic setting, and have not received prior therapy
with an ALK inhibitor.
Approximately 270 patients are expected to be randomized
one-to-one to receive brigatinib (90 mg given orally once daily for
seven days followed by escalation to 180 mg once daily) or
crizotinib (250 mg given orally twice daily). ARIAD expects to
complete patient enrollment in the ALTA 1L trial in 2018.
The primary endpoint of the trial is progression free survival
(PFS), per RECIST criteria as assessed by a blinded Independent
Review Committee (BIRC). Tumor response assessments will be
performed every eight weeks. Key secondary endpoints include
objective response rate (ORR), intracranial ORR, intracranial PFS,
duration of response, overall survival (OS), safety and
tolerability. Health related quality of life data will also be
assessed.
“This head-to-head study will directly test brigatinib against
crizotinib in the TKI-naïve ALK+ setting – where innovative
therapies are needed to improve response rates and to delay
progression that can occur through the emergence of secondary
resistance mutations in ALK and progression in the central nervous
system,” said D. Ross Camidge, M.D., Ph.D., director of thoracic
oncology at the University of Colorado. “In patients who have
experienced crizotinib failure, brigatinib has already exhibited
very impressive progression free survival and marked activity in
patients with CNS metastases – features that suggest that in the
ALK TKI-naive setting, it could potentially change patients’
natural history by better suppressing ALK+ disease from the
beginning.”
About Brigatinib
Brigatinib is an investigational, targeted cancer medicine
discovered internally at ARIAD Pharmaceuticals, Inc. It is in
development for the treatment of patients with ALK+ NSCLC.
Brigatinib received Breakthrough Therapy designation from the FDA
in October 2014 for the treatment of patients with ALK+ NSCLC whose
tumors are resistant to crizotinib on the basis of an ongoing Phase
1/2 trial. Brigatinib is currently being evaluated in the global
Phase 2 ALTA trial in ALK+ NSCLC patients who have progressed on
crizotinib, which is anticipated to form the basis for a new drug
application planned for submission later in 2016.
About ARIAD
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge,
Massachusetts and Lausanne, Switzerland, is an orphan oncology
company focused on transforming the lives of cancer patients with
breakthrough medicines. ARIAD is working on new medicines to
advance the treatment of various forms of chronic and acute
leukemia, lung cancer and other difficult-to-treat orphan cancers.
ARIAD utilizes computational and structural approaches to design
small-molecule drugs that overcome resistance to existing cancer
medicines. For additional information, visit
http://www.ariad.com or follow ARIAD on Twitter
(@ARIADPharm).
Forward-Looking Statements
This press release contains forward-looking statements, each of
which are qualified in their entirety by this cautionary statement.
Any statements contained herein which do not describe historical
facts, including, but not limited to, statements regarding: our
plans for the ALTA IL trial, the trial design and the expected
timing for completion of enrollment; and the statements made by
Drs. Clackson and Camidge, are forward-looking statements that are
based on management’s expectations and are subject to certain
factors, risks and uncertainties that may cause actual results,
outcome of events, timing and performance to differ materially from
those expressed or implied by such statements. These factors, risks
and uncertainties include, but are not limited to, our ongoing
strategic review, our ability to successfully commercialize and
generate profits from sales of Iclusig and our product candidates,
if approved; competition from alternative therapies; our ability to
meet anticipated clinical trial commencement, enrollment and
completion dates and regulatory filing dates for our products and
product candidates and to move new development candidates into the
clinic; our ability to execute on our key corporate initiatives;
regulatory developments and safety issues, including difficulties
or delays in obtaining regulatory and pricing and reimbursement
approvals to market our products; our reliance on the performance
of third-party manufacturers and specialty pharmacies for the
supply and distribution of our products and product candidates; the
occurrence of adverse safety events with our products and product
candidates; the costs associated with our research, development,
manufacturing, commercialization and other activities; the conduct,
timing and results of preclinical and clinical studies of our
products and product candidates, including that preclinical data
and early-stage clinical data may not be replicated in later-stage
clinical studies; the adequacy of our capital resources and the
availability of additional funding; the ability to satisfy our
contractual obligations, including under our leases, convertible
debt and royalty financing agreements; patent protection and
third-party intellectual property claims; litigation; our
operations in foreign countries; risks related to key employees,
markets, economic conditions, health care reform, prices and
reimbursement rates; and other risk factors detailed in our public
filings with the U.S. Securities and Exchange Commission, including
our most recent Annual Report on Form 10-K and subsequent Quarterly
Reports on Form 10-Q. Except as otherwise noted, these
forward-looking statements speak only as of the date of this press
release and we undertake no obligation to update or revise any of
these statements to reflect events or circumstances occurring after
this press release. We caution investors not to place considerable
reliance on the forward-looking statements contained in this press
release.
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version on businesswire.com: http://www.businesswire.com/news/home/20160411005072/en/
ARIAD Pharmaceuticals, Inc.For InvestorsMaria
Cantor, (617) 621-2208Maria.Cantor@ariad.comorFor
MediaLiza Heapes, (617) 621-2315Liza.Heapes@ariad.com
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