ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced the
initiation of a pivotal global Phase 2 trial of AP26113 in patients
with locally advanced or metastatic non-small cell lung cancer
(NSCLC) who were previously treated with crizotinib. The ALTA
(ALK in Lung Cancer Trial of AP26113)
trial is designed to determine the safety and efficacy of AP26113
in refractory NSCLC patients who test positive for the anaplastic
lymphoma kinase (ALK+) oncogene.
“Preliminary data from more than 120 patients studied thus far
in the ongoing Phase 1/2 trial have provided important insights
into the safety and efficacy of AP26113 and its profile at
different dose levels,” said Frank G. Haluska, M.D., Ph.D., senior
vice president of clinical research and development and chief
medical officer at ARIAD. “We anticipate that the Phase 2 ALTA
trial will give us the opportunity to further substantiate these
encouraging findings and, importantly, to study two distinct doses
of AP26113, which will allow for the potential to optimize its
activity in patients with brain metastases.”
Trial Design and Statistical Analysis
Approximately 220 patients with ALK+ NSCLC who have been treated
with and progressed on their most recent crizotinib therapy will be
randomized one-to-one to receive either 90 mg of AP26113 once per
day (QD) continuously, or a lead-in dose of 90 mg QD for seven days
followed by 180 mg QD continuously.
The primary endpoint of the ALTA trial will be objective
response rate (ORR) as measured by RECIST criteria. Secondary
endpoints include time to response, duration of response, disease
control rate, progression-free survival, overall survival, safety,
and tolerability. Health related quality of life will also be
assessed. In patients who have active brain metastases, central
nervous system response will also be measured.
The ALTA trial will be conducted in patients with advanced NSCLC
who have ALK rearrangement documented by fluorescence in situ
hybridization (FISH). The trial will be randomized to independently
examine the overall response rate for each dose level. Patients
will be stratified by response to prior therapy and by the presence
or absence of active brain metastases. The study is designed to
have approximately a 90% power to rule out an uninteresting ORR of
20%, when the true rate is 35% or higher.
“Although crizotinib is effective in metastatic ALK-positive
NSCLC, patients still progress, on average within a year, and
often, that progression is in the brain,” said D. Ross Camidge,
M.D., Ph.D., associate professor of medicine at University of
Colorado School of Medicine. “AP26113 has already shown activity in
post-crizotinib patients with ALK-positive NSCLC, including some
patients with brain metastases. The ALTA trial will evaluate
AP26113 in a larger population of ALK+ patients with acquired
resistance to crizotinib. This will be a great opportunity to
assess the safety and efficacy of two dose levels of this promising
investigational drug in more detail, particularly in patients with
active brain metastases.”
Full patient enrollment in the ALTA trial is expected in the
third quarter of 2015, and final data analysis will be performed
when patients have completed six months of AP26113 treatment. ARIAD
expects to report first data from the trial at a medical meeting in
2015.
The ALTA trial is expected to enroll patients at approximately
100 cancer centers in the United States, Europe, Canada and Asia.
For more information about the trial, patients and physicians
should visit www.clinicaltrials.gov; or call the U.S. toll-free
number 855-552-7423, the EU toll-free number 800 00027423, or the
international number +1 617-503-7423, or email ARIAD at
ClinicalTrials@ariad.com.
About Non-Small Cell Lung Cancer
Lung cancer, both small cell and non-small cell, is the leading
cause of cancer death for both men and women, and about 85 to 90
percent of lung cancers are non-small cell lung cancer (NSCLC).
According to the American Cancer Society, about 224,000 new cases
of lung cancer will be diagnosed in the United States in 2014, and
there will be approximately 159,000 deaths from lung cancer.
Approximately 3 to 5 percent of patients with NSCLC have ALK+
disease.
About AP26113
AP26113 is an investigational oral inhibitor of anaplastic
lymphoma kinase (ALK), a clinically validated target in certain
patients with non-small cell lung cancer, neuroblastomas, sarcomas
and lymphomas. In an ongoing Phase 1/2 clinical trial, AP26113 has
shown anti-tumor activity in patients with ALK+ NSCLC, including
those with active brain metastases.
AP26113 was designed to overcome mutation-based resistance,
including the L1196M “gatekeeper” mutation and other resistance
mutations which have been observed clinically in patients who
initially responded to crizotinib and then relapsed.
About ARIAD
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge,
Massachusetts and Lausanne, Switzerland, is an integrated global
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 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).
This press release contains “forward-looking statements”
including, but not limited to, statements relating to preclinical
and clinical data for AP26113. Forward-looking statements 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 risks and
uncertainties include, but are not limited to, preclinical data and
early-stage clinical data that may not be replicated in later-stage
clinical studies, the costs associated with our research,
development, manufacturing and other activities, the conduct,
timing and results of pre-clinical and clinical studies of our
product candidates, the adequacy of our capital resources and the
availability of additional funding, and other factors detailed in
the Company's public filings with the U.S. Securities and Exchange
Commission. The information contained in this press release is
believed to be current as of the date of original issue. The
Company does not intend to update any of the forward-looking
statements after the date of this document to conform these
statements to actual results or to changes in the Company's
expectations, except as required by law.
For InvestorsKendra Adams,
617-503-7028Kendra.adams@ariad.comorFor MediaLiza Heapes,
617-621-2315liza.heapes@ariad.com
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