ARIAD Presents Updated Clinical Data on brigatinib in Patients with ALK+ Non-Small Cell Lung Cancer at the 2015 ASCO Meeting
June 01 2015 - 9:00AM
Business Wire
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced
updated clinical data on its investigational tyrosine kinase
inhibitor (TKI), brigatinib (AP26113),
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 data
for brigatinib, including updated response rates and median
duration of response in ALK+ NSCLC patients, as well as more
extensive safety data for all patients in the trial.
The updated Phase 1/2 results were presented this morning at the
2015 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 patients
with ALK+ NSCLC (n=79). The presentation is based on patient data
as of February 2015 with a median time on treatment for ALK+ NSCLC
patients of 12.6 months (range, 0.03 – 35.5+ months). Patient
enrollment in the trial is complete, with the last patient enrolled
in July 2014.
“The updated brigatinib data show an objective response rate of
approximately 70 percent in crizotinib-resistant ALK-positive NSCLC
patients,” stated D. Ross Camidge, MD, PhD, director of thoracic
oncology at the Colorado University Cancer Center. “In addition,
the median progression-free survival in this second-line patient
group is now over the one-year mark.”
Key data from the study include:
Safety and Tolerability – All Patients Enrolled
- The most common adverse events (AEs; ≥
30%), regardless of treatment relationship, were nausea (52%),
fatigue (42%), diarrhea (40%), headache (33%), and cough
(32%).
- AEs, grade 3 or higher, occurring in
three or more patients were increased lipase (9%), dyspnea (7%),
hypertension (5%), hypoxia (5%), neoplasm progression (5%),
pneumonia (5%), increased amylase (4%), fatigue (4%), pulmonary
embolism (3%), increased alanine aminotransferase (ALT) (2%),
hyponatremia (2%), hypophosphatemia (2%), and malignant pericardial
effusion (2%).
- Serious AEs, all causality, occurring
in three or more patients were dyspnea (7%), pneumonia (6%),
hypoxia (5%), neoplasm progression (5%), pulmonary embolism (3%),
malignant pericardial effusion (2%), and pyrexia (2%).
- As previously observed and reported,
fewer early-onset pulmonary events, including dyspnea, hypoxia, and
new pulmonary opacities, were reported with a starting dose of 90
mg (2/50 patients, 4%) vs. 180 mg (6/44 patients, 14%). In
addition, no early-onset pulmonary events were observed in the 32
patients started at 90 mg and escalated to 180 mg after seven
days.
Anti-tumor Activity – ALK+ NSCLC Patients
- Of the 78 ALK+ NSCLC patients evaluable
for response, 58 (74%) demonstrated an objective response to
brigatinib. Fifty responses were confirmed by repeat imaging
studies. The “waterfall plot” analysis demonstrated tumor shrinkage
in nearly all ALK+ NSCLC patients, with 25 patients (36%)
experiencing 100% shrinkage of the target lesion.
- Of the eight evaluable TKI-naïve ALK+
NSCLC patients treated with brigatinib, all demonstrated an
objective response (100%), including three complete responses (CR).
Seven responses were confirmed.
- Of the 70 evaluable ALK+ NSCLC patients
with prior crizotinib therapy treated with brigatinib, 50 (71%)
demonstrated an objective response. Forty-three responses were
confirmed.
- The median duration of response was 9.3
months in ALK+ NSCLC patients treated with prior crizotinib therapy
and was not yet reached in ALK+ NSCLC patients who were
crizotinib-naïve.
- Median progression-free survival (PFS)
was 13.4 months in ALK+ NSCLC patients treated with prior
crizotinib therapy and was not yet reached in ALK+ NSCLC patients
who were crizotinib-naïve.
- 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, 52 of 79 ALK+ NSCLC patients were identified to have
intracranial CNS metastases at baseline.
- Of these 52 patients, 17 had measurable
intracranial CNS metastases (15 evaluable), and 35 patients had
only non-measurable intracranial CNS metastases (33
evaluable).
- 8 of 15 (53%) patients with measurable
intracranial CNS metastases had at least 30% reduction in
intracranial target lesion diameter, and 11 of 33 (33%) 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.
Pivotal Phase 2 ALTA Trial Enrolling Patients
A separate, pivotal global Phase 2 trial of brigatinib in
patients with locally advanced or metastatic ALK+ NSCLC who have
progressed on crizotinib is enrolling patients. The ALTA
(ALK in Lung Cancer Trial of AP26113)
trial is designed to determine the safety and efficacy of
brigatinib in refractory ALK+ NSCLC patients. The trial will enroll
approximately 220 patients including those with brain metastasis.
Patients are randomized 1:1 to receive either 90 mg of brigatinib
once per day continuously or a lead-in dose of 90 mg/day for 7 days
followed by 180 mg/day continuously.
“We expect to reach full patient enrollment in the ALTA trial in
the third quarter of this year,” stated Frank G. Haluska, M.D.,
Ph.D., senior vice president of clinical research and development
and chief medical officer at ARIAD. “We are encouraged by the
duration of responses in ALK+ NSCLC patients that have emerged from
the on-going Phase 1/2 brigatinib trial, reinforcing our belief
that brigatinib has the potential to address a significant unmet
medical need in ALK+ NSCLC patients.”
About ARIAD
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge,
Massachusetts and Lausanne, Switzerland, is an integrated global
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 difficult-to-treat 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, the therapeutic potential of
brigatinib, and the estimated timing for completing enrollment in
our ALTA clinical trial, 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/20150601005238/en/
ARIAD Pharmaceuticals, Inc.For InvestorsKendra Adams,
617-503-7028Kendra.adams@ariad.comorFor MediaLiza Heapes,
617-620-4888Liza.heapes@ariad.com
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