- Analysis Also Demonstrated Intracranial
Median Progression-Free Survival (PFS) of 18.4 Months
- 55 Percent Confirmed Systemic Objective
Response Rate
- Investor and Analyst Webcast to be
Held Today at 4:00 p.m. Central European Time (10:00 a.m.
Eastern Time)
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA), a rare
cancer-focused innovative biotechnology company, today announced
clinical data on brigatinib, its investigational anaplastic
lymphoma kinase (ALK) inhibitor, from the pivotal ALTA trial in
ALK-positive (ALK+) non-small cell lung cancer (NSCLC) patients who
had experienced disease progression on crizotinib therapy. As of
May 31, 2016, the data show that of patients on the 180-mg regimen
with a median follow-up of 11 months, 55 percent achieved confirmed
objective response as assessed by the investigator. In this arm,
the median progression-free survival (PFS) was 15.6 months in this
post-crizotinib setting, by both investigator and independent
review committee (IRC) assessment. Additionally, in this arm, 67
percent of patients with measurable brain metastases achieved a
confirmed intracranial objective response, and intracranial PFS was
18.4 months among patients with any brain metastases at baseline.
These data will be presented today at the International Association
for the Study of Lung Cancer (IASLC) 17th World Conference on Lung
Cancer (WCLC) being held in Vienna.
“These updated ALTA trial data show that with additional
follow-up, median progression-free survival from brigatinib given
post-crizotinib is now 15.6 months, and that this is the same
whether assessed by the investigators or an independent review
committee,” said D. Ross Camidge, M.D., Ph.D., director of thoracic
oncology at the University of Colorado. “Whether this is a
reflection of broader suppression of potential resistance
mutations, or its effects on protecting the central nervous system,
or both, requires further investigation but by itself these
progression-free survival data should be very encouraging for
physicians and patients alike. These data really support the idea
to pursue brigatinib, not just post-crizotinib, but also in the
ongoing ALTA 1L study, which aims to assess its potential in the
ALK-treatment naive setting.”
The ALTA Trial
The ALTA (ALK in Lung Cancer Trial of AP26113) trial enrolled
222 patients with ALK+ 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 PFS, confirmed ORR assessed by an IRC, overall
survival (OS), CNS response and PFS, duration of response, safety
and tolerability.
Key Data from the ALTA Trial
Update
Brigatinib Efficacy and Safety in ALK+ NSCLC
Patients:Clinical Data as of May 31, 2016 with IRC Data as
of July 13, 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 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 11 months in
Arm B and 10.2 months in Arm A. ALTA trial data presented at the
2016 American Society of Clinical Oncology (ASCO) meeting, as of
February 29, 2016, had median follow-up of 8.3 months in Arm B and
7.8 months in Arm A.
- Investigator-assessed confirmed ORR in
Arm B was 55 percent. IRC-assessed confirmed ORR in Arm B was 54
percent. Investigator-assessed confirmed ORR in Arm A was 45
percent. IRC-assessed confirmed ORR in Arm A was 49 percent.
- In a subgroup analysis of confirmed ORR
by baseline characteristics, there was no difference in confirmed
ORR based on prior chemotherapy versus no prior chemotherapy.
- The subgroup analysis by best response
to prior crizotinib (partial or complete response versus other)
suggests that patients who had achieved partial or complete
responses on prior crizotinib treatment had a significantly higher
confirmed ORR, compared with patients who did not achieve these
responses.
- 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 15.6 months by both
investigator assessment and IRC assessment in Arm B. Median PFS was
8.8 months by investigator assessment and 9.2 months by IRC
assessment in Arm A.
- Probability of OS at one year was 82
percent and 71 percent in Arm B and Arm A, respectively. The median
OS had not been reached in either arm.
- Of the 44 patients with measurable
intracranial brain metastases at baseline, the IRC-assessed
intracranial ORR was 67 percent (12/18) in Arm B and 46 percent
(12/26) in Arm A.
- The median IRC-assessed intracranial
PFS was 18.4 months in Arm B and 15.6 months in Arm A.
- The most common treatment-emergent
adverse events (TEAEs; ≥ 30% of all patients, [Arm B/A]),
regardless of relationship to treatment, were nausea (43%/36%),
diarrhea (39%/21%), cough (36%/23%), headache (30%/28%) and
increased blood creatine phosphokinase (CPK) (33%/11%).
- TEAEs, grade ≥3, occurring in ≥4
percent of all patients (excluding neoplasm progression; Arm B/A),
were increased CPK (10%/3%), hypertension (6%/6%), pneumonia
(5%/3%) and increased lipase (3%/5%).
- A subset of pulmonary adverse events
(AEs) with early onset (median: Day 2; range: Day 1-9) occurred in
six 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 10 percent/three percent and 23
percent/eight percent, respectively. Discontinuations due to
documented progressive disease (Arm B/A) were 23 percent and 30
percent.
“We are encouraged by the maturing efficacy and safety profile
of brigatinib in this later data cut, which adds three months of
follow up compared to the data presented at ASCO,” stated Timothy
P. Clackson, Ph.D., president of research and development and chief
scientific officer at ARIAD. “These data are intended to be
submitted to the European Medicines Agency in early 2017 for
marketing approval. Pending regulatory review, we expect that
brigatinib may become an important therapeutic option for the
crizotinib-resistant population.”
The poster presentation, “Brigatinib in Crizotinib-Refractory
ALK+ NSCLC: Central Assessment and Updates from ALTA, a Pivotal
Randomized Phase 2 Trial,” (Abstract #4046, Poster ID P3.02a-013)
will be presented today, Wednesday, December 7, 2016 from 14:30 -
15:45 GMT.
About Brigatinib
Brigatinib is an investigational, targeted cancer medicine
discovered internally at ARIAD. 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.
ARIAD has also initiated the Phase 3 ALTA 1L trial to assess the
efficacy and safety of brigatinib in comparison to crizotinib in
patients with locally advanced or metastatic ALK+ NSCLC who have
not received prior treatment with an ALK inhibitor. More
information on brigatinib clinical trials, including the expanded
access program (EAP) for ALK+ NSCLC can be found here.
Investor and Analyst Briefing and Webcast
Timothy P. Clackson, Ph.D., president of research and
development and chief scientific officer of ARIAD will host an
investor and analyst briefing today, Wednesday, December 7, at 4:00
p.m. Central European Time (10:00 a.m. Eastern Time) to discuss the
data presented at WCLC. Dr. Clackson will be joined by Karen
Reckamp, MD, associate professor in the Department of Medical
Oncology & Therapeutics Research and co-director of the Lung
Cancer and Thoracic Oncology Program at City of Hope Comprehensive
Cancer Center (COHCCC).
The live webcast can be accessed by visiting the investor
relations section of the Company’s website
at http://investor.ariad.com. The call can be accessed by
dialing 844-249-9386 (domestic) or 270-823-1534 (international)
five minutes prior to the start time and providing the pass code
20888507. A replay of the call will be available on the ARIAD
website approximately two hours after completion of the call and
will be archived for three weeks.
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 the
potential promise and importance of brigatinib as a potential
treatment option for ALK+ lung cancer patients, additional clinical
data that may be reported on brigatinib and the expected timing and
actions on 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20161207005305/en/
ARIAD Pharmaceuticals, Inc.For InvestorsManmeet Soni,
617-503-7298Manmeet.soni@ariad.comorFor MediaLiza Heapes,
617-621-2315Liza.heapes@ariad.com
Ariad (NASDAQ:ARIA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Ariad (NASDAQ:ARIA)
Historical Stock Chart
From Apr 2023 to Apr 2024