~ Investigational Medicine Brigatinib
Demonstrates 53 Percent Confirmed Objective Response Rate and
15.6-Month Median Progression-Free Survival by Independent Review
Committee Assessment in ALTA Study Abstract~ WCLC Oral and Poster
Presentations to Include Approximately Three Months of Additional
Follow-up Compared to Abstracts
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA), a rare
cancer-focused innovative biotechnology company, today announced
that clinical data on brigatinib, its investigational anaplastic
lymphoma kinase (ALK) inhibitor, will be presented at the
International Association for the Study of Lung Cancer (IASLC) 17th
World Conference on Lung Cancer (WCLC) being held in Vienna,
December 4 to 7, 2016.
“We are excited that updated data from the ALTA trial on
brigatinib in patients with ALK-positive non-small cell lung cancer
will be presented at WCLC this year. We continue to be encouraged
by the activity and safety profile seen in the ALTA trial, and
especially the correlation between investigator and independent
review assessments of response and response durability. ALTA data
to be presented at the meeting will include approximately three
months of additional follow-up as compared to the abstract,” stated
Timothy P. Clackson, Ph.D., president of research and development
and chief scientific officer at ARIAD.
The ALTA trial
The ALTA (ALK in Lung Cancer Trial of AP26113) trial enrolled
222 patients with ALK-positive (ALK+) non-small cell lung cancer
(NSCLC) who had been treated with and experienced disease
progression on their most recent crizotinib therapy. Patients were
randomized one-to-one to receive either 90 mg of brigatinib once
per day (QD) (Arm A), or 180 mg QD, preceded by a lead-in dose of
90 mg QD for seven days (Arm B). In addition, patients were
stratified by presence of brain metastases at baseline and best
response to prior crizotinib therapy.
The primary endpoint of the ALTA 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 and
PFS, duration of response, safety and tolerability.
Brigatinib received Breakthrough Therapy designation from the
FDA for the treatment of patients with ALK+ NSCLC whose tumors are
resistant to crizotinib, and was granted orphan drug designation by
the FDA for the treatment of ALK+ NSCLC. The FDA has accepted
brigatinib’s New Drug Application and has granted ARIAD’s request
for Priority Review and set an action date of April 29,
2017 under the Prescription Drug User Fee Act (PDUFA). ARIAD
intends to submit a Marketing Authorization Application (MAA) for
brigatinib to the European Medicines Agency (EMA) in early
2017.
Abstract Highlights on ALTA Trial UpdateData as of
February 29, 2016 with Independent Review Committee (IRC) Data as
of May 16, 2016
- Accepted as a poster presentation, this
abstract reports updated clinical data from the ALTA trial. 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 a seven-day lead-in at 90 mg and 112
patients in Arm A at the 90 mg dose level). The last patient was
enrolled in the study in September 2015.
- The median follow-up was 8.3 months in
Arm B and 7.8 months in Arm A.
- Investigator-assessed confirmed ORR in
Arm B was 54 percent. IRC-assessed confirmed ORR in Arm B was 53
percent. Investigator-assessed confirmed ORR in Arm A was 45
percent. IRC- assessed confirmed ORR in Arm A was 48 percent.
- Investigator-assessed median PFS was
12.9 months and 9.2 months in Arm B and Arm A, respectively.
- IRC-assessed median PFS was 15.6 months
and 9.2 months in Arm B and Arm A, respectively.
- The most common treatment-emergent
adverse events (AEs), grade 3 or higher, (Arm B/A) were (excluding
neoplasm progression): hypertension (6%/6%), increased creatine
phosphokinase (CPK) (9%/3%), pneumonia (5%/3%), and increased
lipase (3%/4%).
- A subset of pulmonary AEs with early
onset occurred in six percent of all patients (in 3% of patients,
events were grade 3 or higher); no such events occurred after dose
escalation to 180 mg QD in Arm B.
Abstract Highlights from Update on Clinical Data from
Patients with Baseline CNS Metastases from Phase 1/2 and ALTA
TrialsData as of February 29, 2016 in ALTA Trial, and
November 16, 2015 in Phase 1/2 Trial
- Accepted as an oral presentation, this
abstract reports clinical data from the Phase 1/2 and ALTA trials
of brigatinib in patients with ALK+ NSCLC who had brain metastases
at baseline.
- In the Phase 1/2 trial, patients with
advanced malignancies, including ALK+ NSCLC, received 30-300 mg of
brigatinib per day. Efficacy in both trials and safety in ALTA are
reported for patients with intracranial CNS metastases at
baseline.
- In the Phase 1/2 trial of brigatinib,
50/79 (63%) of ALK+ NSCLC patients had IRC-assessed baseline brain
metastases. In the ALTA trial, 153/222 (69%) of ALK+ NSCLC patients
had IRC-assessed baseline brain metastases. The efficacy analysis
of Phase 1/2 trial data was based on an evaluable population
(patients with at least one on-study brain scan, n=46), and the
analysis of ALTA trial data was based on the intention-to-treat
(ITT) population (n=153).
- For patients with measurable brain
lesions, the confirmed intracranial objective response rate was 53
percent (8/15) in the Phase 1/2 trial, and confirmed
intracranial objective response rates were 67 percent (12/18)
in Arm B and 42 percent (11/26) in Arm A in the ALTA
trial.
- There were 31 patients in the Phase 1/2
trial with only non-measurable lesions, and of these, 35 percent
had complete resolution of lesions. In ALTA, there were 55 patients
in Arm B and 54 in Arm A with only non-measurable lesions; of
these, 18 percent and seven percent of patients, respectively, had
complete resolution of lesions.
- For patients with brain metastases at
baseline, median intracranial PFS was 15.6 months in the Phase 1/2
trial (n=46); and 12.8 months (95% confidence interval [CI] 11.0 –
not reached) and 15.6 months (95% CI 7.3-15.7 months) in ALTA Arm B
and Arm A, respectively (n=73/ n=80).
- In the ALTA trial, the most common
treatment-emergent AEs, grade 3 or higher (excluding neoplasm
progression), in patients with baseline brain metastases were
(n=151 treated; Arm B/A): increased CPK (11%/1%), hypertension
(7%/4%), increased lipase (3%/3%), and pneumonia (4%/1%).
For both presentations, ALTA data to be presented at the
conference in Vienna will be based on an updated analysis, with a
data cutoff date of May 31, 2016. These updated data will be
included in the MAA application.
The schedule and meeting location for the sessions at WCLC,
together with the abstract information and ARIAD’s investor event
and NSCLC symposium, are listed below (all times are Central
European Time Zone):
Brigatinib Oral Presentation
Title:
Brigatinib Activity in Patients with
ALK+ NSCLC and Intracranial CNS Metastases in Two Clinical
Trials
Abstract No/ID: 4374; Oral ID: OA08.06 Presenter: Scott Gettinger,
M.D. (Yale Cancer Center) Oral Session: Targeted Therapies in Brain
Metastases Session Date & Time: Monday, December 5, 2016, 16:00
– 17:30 Presentation Time: 11:57 a.m. to 12:09 p.m. Location:
Schubert 1
Brigatinib Posters
Title:
Brigatinib in Crizotinib-Refractory
ALK+ NSCLC: Central Assessment and Updates from ALTA, a Pivotal
Randomized Phase 2 Trial
Abstract No/ID: 4046; Poster ID: P3.02a-013 Presenter: D.
Ross Camidge, M.D., Ph.D. (Colorado University Cancer Center)
Poster Session: PS03 Date & Time: Wednesday, December 7, 2016,
14:30 – 15:45 Location:
Hall B, poster area
Title:
Indirect Naive Comparison of
Post-Crizotinib Treatments for ALK+ Non–Small Cell Lung Cancer
(NSCLC)
Abstract No/ID: 4459; Poster ID: P3.02a-017 Presenter: Karen L.
Reckamp, M.D. (City of Hope) Poster Session: PS03 Date & Time:
Wednesday, December 7, 2016, 14:30 – 15:45 Location: Hall B, poster
area
AP32788 Poster
Title:
A Phase 1/2 Trial of the Oral EGFR/HER2
Inhibitor AP32788 in Non–Small Cell Lung Cancer (NSCLC)
Abstract No/ID: 5047; Poster ID: P2.06-007 Presenter: Robert C.
Doebele, M.D., Ph.D. (University of Colorado) Poster Session: PS02
Date & Time: Tuesday, December 6, 2016, 14:30 – 15:45 Location:
Hall B, poster area
Investor and Analyst Briefing and Webcast
A webcast briefing will be held to review the updated brigatinib
clinical data from the WCLC. Details will be provided at a later
date.
NSCLC Global Symposium at WCLC
ARIAD will host a symposium titled, “Current and emerging
treatments for patients with ALK+ NSCLC,” that is open to all
registered WCLC attendees. This symposium will be co-hosted by D.
Ross Camidge, M.D., Ph.D., director of thoracic oncology at the
University of Colorado and Professor Christoph Zielinski, M.D.,
Ph.D., chairman of the Clinical Division of Oncology, Medical
University Vienna, Austria. They will be joined by Pasi A. Jänne,
M.D., Ph.D., professor of medicine at the Dana Farber Cancer
Institute, Boston, MA, USA, to review ALK inhibitor sequencing, the
role of mutation testing, and current and future potential ALK
inhibitors.
Date: Sunday, December 4, 2016 Time: 12:00 to 13:30
p.m. (CET) Location: Strauss 3, Messe Wien Exhibition &
Congress Center, Vienna Congress:
17th World Conference on Lung Cancer
(WCLC) hosted by the International Association for the Study of
Lung Cancer (www.IASLC.org)
About ARIAD
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge,
Massachusetts, is focused on discovering, developing and
commercializing precision therapies for patients with rare cancers.
ARIAD is working on new medicines to advance the treatment of rare
forms of chronic and acute leukemia, lung cancer and other rare
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 related to additional clinical data to be reported on
brigatinib and our regulatory filings for brigatinib, 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 ability to successfully
commercialize and generate profits from sales of our products; 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; competition from
alternative therapies; our reliance on the performance of
third-party manufacturers, specialty pharmacies, distributors and
other collaborators for the supply, distribution, development
and/or commercialization 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
and government investigations; our operations in foreign countries
with or through third parties; 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/20161116006641/en/
ARIAD Pharmaceuticals, Inc.For InvestorsJennifer
Robinson, 617-621-2286Jennifer.Robinson@ariad.comFor
MediaLiza Heapes, 617-621-2315Liza.heapes@ariad.com
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