ARIAD Presents Updated Long-Term Follow-up Results from the Phase 1/2 Trial on Investigational Drug Brigatinib at 2016 ESMO M...
October 10 2016 - 7:35AM
Business Wire
~In ALK+ NSCLC patients with prior crizotinib
treatment, the confirmed ORR was 62% and median PFS was 12.9
months
~In eight crizotinib-naive ALK+ NSCLC patients,
the confirmed ORR was 100%
~Safety profile was similar with longer
follow-up
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 updated Phase 1/2 results were included in a poster
presentation on Sunday, October 9 at the 41st Annual Congress of
the European Society for Medical Oncology (ESMO) held in
Copenhagen, Denmark.
Phase 1/2 Study
The data presented at ESMO 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 therapy. The presentation is
based on patient data as of May 2016 with a median time on
brigatinib treatment for ALK+ NSCLC patients of 20.0 months (range,
0.03 – 47.4 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
continues to show anti-tumor activity with a confirmed overall
objective response rate of 62 percent in crizotinib-resistant
ALK-positive NSCLC patients at all doses evaluated, and 76 percent
among those patients who received the 180 mg dose regimen with a
seven-day lead-in at 90 mg once daily,” stated Lyudmila A.
Bazhenova, M.D., a clinical professor of medicine at the University
of California San Diego Moores Cancer Center. “The median
progression-free survival in this post-crizotinib ALK+ NSCLC
patient group continues to exceed one year.”
Key data from the study include:
Anti-tumor Activity of Brigatinib in ALK+ NSCLC
PatientsData as of May 31, 2016
- Of the 71 ALK+ NSCLC patients with
prior crizotinib therapy, 44 (62%) achieved a confirmed objective
response to brigatinib.
- Of the 25 patients treated with the 180
mg dose regimen (with 90 mg lead-in), 19 (76%) achieved a confirmed
objective response.
- Of the eight crizotinib-naive ALK+
NSCLC patients treated with brigatinib, all achieved an objective
response (100%), including three complete responses (CR). All
responses were confirmed.
- The “waterfall plot” analysis
demonstrated 100 percent tumor shrinkage of target lesions in 24
(33%) of 72 evaluable ALK+ NSCLC patients.
- 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. The longest time on treatment for a patient who
was crizotinib-naive was 47.4 months.
- The probability of overall survival
(OS) at one year was 77 percent in ALK+ NSCLC patients who received
prior crizotinib therapy (projected two-year OS was 61%) and 100
percent in patients who were crizotinib-naive (projected two-year
OS was 100%).
CNS Anti-tumor Activity of Brigatinib in ALK+ NSCLC
PatientsData as of October 8, 2015
- An evaluation of the efficacy of
brigatinib in ALK+ NSCLC patients with intracranial CNS metastases
at baseline was also included in the poster. 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 14.6
months. Median duration of intracranial response in confirmed
responders was 11.4 months.
Safety and Tolerability – All Patients EnrolledData as of
May 31, 2016
- The most common treatment-emergent
adverse events (AEs; ≥ 30%), regardless of relationship to
treatment, were nausea (53%), fatigue (45%), diarrhea (42%),
headache (35%), and cough (33%).
- Treatment-emergent AEs, regardless of
relationship to treatment, grade 3 or higher, occurring in ≥4
percent of patients (excluding disease progression) were increased
lipase (12%), pneumonia (7%), dyspnea (6%), hypoxia (6%),
hypertension (5%), increased amylase (4%), fatigue (4%),
hypophosphatemia (4%), and hyponatremia (4%).
- Serious treatment-emergent AEs,
regardless of relationship to treatment, occurring in ≥2 percent of
patients (excluding disease progression) were pneumonia (7%),
dyspnea (6%), hypoxia (5%), pneumonitis (3%), pulmonary embolism
(3%), confusional state (2%), malignant pericardial effusion (2%),
and seizure (2%).
- A subset of pulmonary AEs (including
dyspnea, hypoxia, pneumonia and/or pneumonitis) was observed to
occur within seven 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 and empiric treatment
(steroids and/or antibiotics).
- 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 seven days followed by 180 mg qd, no such events were reported
after dose escalation.
- Administration of brigatinib at 180 mg
with a seven-day lead-in at 90 mg appears not to 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. It is in development for the
treatment of patients with anaplastic lymphoma kinase positive
(ALK+) non-small cell cancer (NSCLC). The global Phase 2 ALTA
trial, designed to determine the safety and efficacy of brigatinib
in refractory ALK+ NSCLC patients who have been treated with and
progressed on their most recent crizotinib therapy, is the basis
for brigatinib’s initial regulatory review. 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.
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. 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, 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 and specialty pharmacies or our
collaborators 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20161010005510/en/
ARIAD Pharmaceuticals, Inc.For InvestorsManmeet S. Soni,
617-503-7298Manmeet.soni@ariad.comFor MediaLiza Heapes,
617-621-2315Liza.heapes@ariad.com
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