ARIAD Presents Data from Mutational Profiling in Crizotinib-Resistant Patients Treated with Investigational Medicine Brigatin...
June 04 2016 - 7:35AM
Business Wire
~Brigatinib Achieves Confirmed Response in
Patient with G1202R Mutation that Emerges Following Treatment with
Current Approved Therapies
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced
clinical data from an analysis aimed at characterizing the activity
of its investigational tyrosine kinase inhibitor (TKI), brigatinib,
in patients with anaplastic lymphoma kinase positive (ALK+)
advanced non-small cell lung cancer (NSCLC) who have progressed on
crizotinib. The analysis was based on ALK mutation status as
determined by next-generation sequencing (NGS) of tumor tissue
collected from the ongoing Phase 1/2 and ALTA clinical trials.
Data from this analysis showed that brigatinib yields confirmed
responses in patients with multiple different secondary ALK
mutations, including one G1202R case. There are no currently
approved ALK treatments that have demonstrated activity against the
G1202R mutation.
These data are being presented today at the 2016 American
Society of Clinical Oncology (ASCO) annual meeting in Chicago.
Study Methods
Requirements for the Phase 1/2 and ALTA trials of brigatinib
included that tumor tissue be collected at patient screening after
failure on crizotinib therapy and prior to brigatinib treatment. An
optional post-baseline tumor biopsy also was requested following
disease progression on brigatinib. Tumor samples were analyzed
using a NGS (next-generation sequencing) platform that examined the
entire coding sequence of 315 cancer-related genes plus introns
from 28 genes often rearranged or altered in cancer. This analysis
focuses on the relationship between brigatinib clinical activity
and ALK mutation status at baseline and after disease progression
on brigatinib therapy.
A total of 32 baseline tumor samples from the clinical trials of
brigatinib were evaluable using NGS, and a total of six
post-baseline samples following disease progression on brigatinib
were evaluable by NGS.
Study Results
- Of the 32 patients with baseline NGS
data, 22 (69%) achieved a confirmed objective response on
brigatinib.
- Of the 9 patients with secondary ALK
mutations at baseline, 7 (78%) achieved a confirmed objective
response on brigatinib.
- Of the 23 patients without secondary
ALK mutations at baseline, 15 (65%) achieved a confirmed objective
response rate (ORR) on brigatinib.
- Of the 6 patients with evaluable tissue
samples collected after progression on brigatinib therapy, 5 (83%)
were determined to have detectable secondary mutations in the ALK
kinase domain. Three out of five of these patients had complex
mutation patterns, following responses lasting 5.4, 7.4 and 28.5
months. Two out of five had single secondary ALK kinase domain
mutations detected, following responses lasting 10.9 and 11
months.
- Of the one patient with a secondary
G1202R mutation, the patient achieved a confirmed response on
brigatinib and the response is on-going.
“It is encouraging that responses to brigatinib were observed in
patients with crizotinib resistant ALK+ lung cancer with and
without the presence of ALK resistance mutations. This is
consistent with preclinical studies showing brigatinib to be a
potent pan-inhibitor of all known ALK secondary resistance
mutants,” stated Scott N. Gettinger, M.D., associate professor of
medicine at Yale Cancer Center.
About ARIADARIAD 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
StatementsThis 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, 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160604005020/en/
ARIAD Pharmaceuticals, Inc.For InvestorsManmeet S. 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