ARIAD Presents Long-Term Phase 1/2 Trial Follow up on Investigational Drug Brigatinib with Median Time on Treatment of 17 Mon...
June 04 2016 - 7:35AM
Business Wire
~ Longest Time on Treatment Now More Than 3.5
Years for Patients with ALK+ Non-Small Cell Lung Cancer
~ Data from Phase 1/2 Clinical Trial Presented
at 2016 ASCO Meeting
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced
updated clinical data on its investigational tyrosine kinase
inhibitor (TKI), brigatinib, in patients with anaplastic lymphoma
kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC)
from an ongoing Phase 1/2 trial. The current results include more
mature efficacy and safety data for brigatinib, including updated
response rates and median duration of response in ALK+ NSCLC
patients.
The updated Phase 1/2 results are being presented today at the
2016 American Society of Clinical Oncology (ASCO) annual meeting in
Chicago.
Phase 1/2 Study
The data presented at ASCO include safety analyses on all
patients in the trial (n=137) and efficacy analyses on all patients
with ALK+ NSCLC (n=79). Of the 79 ALK+ NSCLC patients, all but
eight had failed prior crizotinib. The presentation is based on
patient data as of November 2015 with a median time on treatment
for ALK+ NSCLC patients of 17.0 months (range, 0.03 – 44.4 months,
ongoing). Patient enrollment in the trial is complete, with the
last patient enrolled in July 2014.
“The long-term follow up on this clinical trial of brigatinib
shows substantial anti-tumor activity with an objective response
rate of approximately 72 percent in crizotinib-resistant
ALK-positive NSCLC patients,” stated D. Ross Camidge, M.D., Ph.D.,
director of thoracic oncology at the Colorado University Cancer
Center. “The median progression-free survival in this
post-crizotinib patient group exceeds one-year and has not yet been
reached in patients not previously treated with crizotinib.
Importantly, no new safety signals have emerged at this later time
of follow up.”
Key data from the study include:
Anti-tumor Activity of Brigatinib in ALK+ NSCLC
Patients
- Of the 71 ALK+ NSCLC patients with
prior crizotinib therapy, 51 (72%) demonstrated an objective
response to brigatinib. Forty-four responses were confirmed (62%).
- Of the 25 patients treated at the 180
mg dose regimen that included a seven-day lead-in dose of 90 mg, 20
(80%) demonstrated an objective response, of which 19 (76%) were
confirmed.
- Of the eight crizotinib-naive ALK+
NSCLC patients treated with brigatinib, all demonstrated an
objective response (100%), including three complete responses (CR).
All responses were confirmed.
- The “waterfall plot” analysis
demonstrated tumor shrinkage in nearly all ALK+ NSCLC patients,
with 21 patients experiencing 100 percent shrinkage of the target
lesions.
- The median duration of response in
confirmed responders was 14.5 months in ALK+ NSCLC patients treated
with prior crizotinib therapy and was not yet reached in ALK+ NSCLC
patients who were crizotinib-naive.
- Median progression-free survival (PFS)
was 12.9 months in ALK+ NSCLC patients with prior crizotinib
therapy and was not yet reached in ALK+ NSCLC patients who were
crizotinib-naive.
- Overall survival (OS) at one year was
77 percent in patients who received prior crizotinib (projected
2-year OS was 63%) and 100 percent in patients who were
crizotinib-naive (projected 2-year OS was 100%).An evaluation of
the efficacy of brigatinib in ALK+ NSCLC patients with intracranial
CNS metastases at baseline was also included in the ASCO
presentation. In an independent central review of brain magnetic
resonance imaging (MRI) scans, 46 ALK+ NSCLC patients were
evaluable for intracranial response, including 15 who had
measurable intracranial CNS metastases at baseline, and 31 patients
who had only non-measurable intracranial CNS metastases.
- 10 of 15 (67%) patients with measurable
intracranial CNS metastases had an intracranial objective response,
and 13 of 31 (42%) with only non-measurable intracranial CNS
metastases had complete disappearance of intracranial lesions.
- Median intracranial PFS for ALK+ NSCLC
patients with intracranial CNS metastases at baseline was 15.6
months. Median duration of intracranial response in confirmed
responders was 11.4 months.
Safety and Tolerability – All Patients Enrolled
- The most common treatment-emergent
adverse events (AEs; ≥ 30%), regardless of relationship to
treatment, in all patients were nausea (51%), fatigue (42%),
diarrhea (41%), headache (34%), and cough (33%).
- Treatment-emergent AEs, regardless of
relationship to treatment, grade 3 or higher, occurring in ≥4%
patients were increased lipase (9%), dyspnea (7%), hypertension
(5%), increased amylase (4%), and fatigue (4%)
- Serious treatment-emergent AEs,
regardless of relationship to treatment, occurring in three or more
patients were dyspnea (7%), pneumonia (7%), hypoxia (5%), pulmonary
embolism (3%), malignant pericardial effusion (2%), and pneumonitis
(2%).
- A subset of pulmonary AEs (including
dyspnea, hypoxia, pneumonia and/or pneumonitis) was observed to
occur within 7 days of treatment initiation or treatment
re-initiation following a prolonged dose interruption. Most events
occurred within 48 hours of dosing and were generally managed with
dose interruption or discontinuation.
- Rates of these AEs were numerically
lower with lower starting doses (11/137 [8%], overall)
- 6/44 (14%) in patients started at 180
mg qd
- 1/50 (2%) in patients started at 90 mg
qd
- Among 32 patients treated with 90 mg qd
for 7 days followed by 180 mg qd, no such events were reported
after dose escalation
- Administration of brigatinib at 180 mg
with a 7-day lead-in at 90 mg appears to not be associated with an
increased risk of additional early pulmonary AEs, when compared
with continuous administration of brigatinib at 90 mg.
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 anaplastic lymphoma
kinase positive (ALK+) non-small cell cancer (NSCLC) whose disease
is resistant to crizotinib. Brigatinib is currently being evaluated
in the global Phase 2 ALTA trial that is anticipated to form the
basis for its initial regulatory review. ARIAD has also initiated
the Phase 3 ALTA 1L trial to assess the efficacy of brigatinib in
comparison to crizotinib. More information on brigatinib clinical
trials, including the expanded access program (EAP) can be found
here.
About ARIAD
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge,
Massachusetts 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 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 StatementsThis
press release contains forward-looking statements. Any statements
contained herein which do not describe historical facts, including,
but not limited to, statements regarding: updated clinical data for
brigatinib and the therapeutic potential of brigatinib are
forward-looking statements which 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, among others: early-stage clinical data may not be
replicated in later-stage clinical studies; the costs associated
with our research, development, manufacturing and other activities;
the adequacy of our capital resources and the availability of
additional funding; our ongoing and additional clinical trials of
brigatinib may not be successful or initiated, enrolled or
conducted in a timely manner; regulatory developments and safety
issues; competitive risks; manufacturing issues and those
additional 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. All
forward‐looking statements in this press release are qualified in
their entirety by this cautionary statement.
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version on businesswire.com: http://www.businesswire.com/news/home/20160604005018/en/
ARIAD Pharmaceuticals, Inc.For InvestorsManmeet S. Soni,
617-503-7298Manmeet.soni@ariad.comorFor MediaLiza Heapes,
617-621-2315Liza.heapes@ariad.com
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