~ 67 Percent Confirmed Intracranial Objective
Response Rate in Patients with Measurable Brain Metastases
~ Data from Pivotal Study in Refractory ALK
Positive Non-Small Cell Lung Cancer Patients
~ Investor and Analyst Webcast to be Held at
the 2016 ASCO Meeting Today at 7 a.m. CT
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced
updated clinical data on brigatinib, its investigational anaplastic
lymphoma kinase (ALK) inhibitor, from the pivotal ALTA trial in
patients who had experienced disease progression on crizotinib
therapy. The data show that, of patients on the 180 mg regimen (Arm
B) with a median follow-up of 8.3 months, 54 percent achieved a
confirmed objective response, the trial’s primary endpoint. In this
arm, the median progression free survival (PFS) exceeded one year
(12.9 months) in this post-crizotinib setting. Additionally, a 67
percent confirmed intracranial objective response rate (ORR) was
achieved in patients with measurable brain metastases. These data
will be presented today, for the first time, at the Annual Meeting
of the American Society of Clinical Oncology (ASCO), reflecting an
additional 12 weeks of patient follow up and new data on central
nervous system (CNS) activity compared to the abstract released
last month.
“Most patients with ALK-positive non-small cell lung cancer who
are treated with crizotinib eventually experience disease
progression, often due to acquired ALK resistance mutations or
metastases in the central nervous system,” said presenting author
Dong-Wan Kim, M.D., Ph.D., head of the Cancer Clinical Trials
Center at the Seoul National University Hospital in South Korea.
“For these patients, we are very excited by the brigatinib ALTA
trial data, which showed compelling efficacy and safety data,
including complete responses and activity in the CNS.”
The ALTA trial
The primary endpoint of the ALTA (ALK in Lung Cancer Trial of
AP26113) trial is investigator-assessed confirmed objective
response rate (ORR) as measured by the Response Evaluation Criteria
in Solid Tumors (RECIST). Key secondary endpoints include
progression free survival (PFS), confirmed ORR assessed by an
independent review committee (IRC), CNS response (IRC-assessed
intracranial ORR and PFS), overall survival, safety and
tolerability. Brigatinib was granted the U.S. Food and Drug
Administration (FDA) Orphan Drug designation for ALK+ non-small
cell lung cancer (NSCLC) and the FDA Breakthrough Therapy
designation for the treatment of patients with ALK+ non-small cell
lung cancer (NSCLC) that is resistant to crizotinib.
The trial enrolled 222 patients with ALK+ NSCLC who had been
treated with and experienced disease progression on crizotinib.
Patients were randomized one-to-one to receive either 90 mg of
brigatinib once per day (QD) (Arm A), or 180 mg QD with a seven day
lead-in at 90 mg QD (Arm B).
In addition, patients were stratified by the presence of brain
metastases at baseline and best response to prior crizotinib.
Key Data from the ALTA
Trial
Brigatinib Efficacy and Safety in ALK+ NSCLC
Patients:
Data as of February 29, 2016
- A total of 222 patients with ALK+ NSCLC
treated with prior crizotinib therapy were randomized in the study
(110 patients in Arm B at the 180 mg dose level with 7-day lead-in
at 90 mg and 112 patients in Arm A at the 90 mg dose level). The
last patient enrolled in the study in September 2015.
- The median follow-up was 8.3 months in
Arm B (range 0.1—20.2) and 7.8 months in Arm A (range
0.1—16.7).
- Investigator-assessed confirmed ORR in
Arm B was 54 percent, including four complete responses. Confirmed
ORR in Arm A was 45 percent, including one complete response.
- Responses in Arm B included a confirmed
partial response in a patient with the ALK kinase domain G1202R
mutation at baseline, which is associated with resistance to all
approved tyrosine kinase inhibitors (TKIs).
- Median PFS was 12.9 months and 9.2
months in Arm B and Arm A, respectively. Probability of overall
survival (OS) at 1-year was 80 percent and 71 percent in Arm B and
Arm A, respectively.
- 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, 18 patients in Arm B
and 25 patients in Arm A were identified as having measurable CNS
metastases at baseline.
- Among patients with measurable CNS
metastases at baseline, the IRC-assessed confirmed intracranial ORR
was 67 percent (12/18) in Arm B and 36 percent (9/25) in Arm A;
among the subset of patients with measurable, active brain
metastases, confirmed intracranial ORR was 73 percent (11/15) in
Arm B and 36 percent (7/19) in Arm A. Measurable, active brain
metastases are defined as having had no prior radiotherapy or
progression following radiotherapy.
- Median intracranial PFS for patients
with intracranial CNS metastases at baseline was not yet reached in
Arm B and was 15.6 months in Arm A.
- The most common treatment-emergent
adverse events (TEAEs; ≥ 25% of all patients, [Arm B/A]),
regardless of relationship to treatment, were nausea (40%/33%),
diarrhea (38%/19%), cough (34%/18%), and headache (27%/28%).
- TEAEs, ≥ grade 3, occurring in ≥ 5
percent of all patients (Arm B/A), were increased blood creatine
phosphokinase (9%/3%) and hypertension (6%/6%).
- A subset of pulmonary adverse events
with early onset (median: Day 2; range: Day 1-9) occurred in 6
percent of all patients (≥ grade 3 in 3% of patients); no such
events with early onset occurred after dose escalation to 180 mg QD
in Arm B.
- Discontinuations and dose reductions
due to AEs (Arm B/A) were 8 percent/3 percent and 20 percent/7
percent, respectively. Discontinuations due to progressive disease
(Arm B/A) were 17 percent and 30 percent.
“The ALTA trial data support our planned NDA submission with a
recommendation for dosing with 180 mg once daily following a
seven-day lead-in at 90 mg. We are on track for submission in the
third quarter,” stated Timothy P. Clackson, Ph.D., president of
research and development and chief scientific officer at ARIAD. “We
believe brigatinib’s antitumor activity both on disease in the
lungs and in the central nervous system, safety profile, and
once-daily dosing regimen taken with or without food, provide the
potential for brigatinib to be an important new therapeutic option
for the crizotinib-resistant patient population.”
Investor and Analyst Briefing and Webcast
A breakfast meeting featuring D. Ross Camidge, M.D., Ph.D.,
director of thoracic oncology at the Colorado University Cancer
Center, to review the updated brigatinib clinical data from the
ALTA trial will be webcast live along with slides and can be
accessed by visiting the investor relations section of ARIAD’s
website at http://investor.ariad.com.
Date: Monday, June 6,
2016 Time: 7:00 a.m. to 8:00 a.m. (CT) Location: Hyatt McCormick
Place
A replay of the investor event will be available on the ARIAD
website approximately three hours after the presentation and will
be archived on the site for four weeks. To ensure a timely
connection to the live webcast, participants should log onto the
webcast at least 15 minutes prior to the scheduled start time.
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.
Brigatinib Oral Presentation
The oral presentation, “Brigatinib (BRG) in patients (pts) with
crizotinib (CRZ)- refractory ALK+ non–small cell lung cancer
(NSCLC): first report of efficacy and safety from a pivotal
randomized phase (ph) 2 trial (ALTA),” (Abstract #9007) will be
presented today, Monday, June 6 in the Arie Crown Theater at 11:57
a.m. CT.
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 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 the statements made by Drs.
Kim and Clackson, 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160606005347/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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