ARIAD’s AP26113 Receives FDA Breakthrough Therapy Designation For ALK+ Non-Small Cell Lung Cancer Resistant to Crizotinib
October 02 2014 - 7:35AM
Business Wire
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that
its investigational cancer medicine, AP26113, has received
Breakthrough Therapy designation by the U.S. Food and Drug
Administration (FDA) for the treatment of patients with anaplastic
lymphoma kinase positive (ALK+) metastatic non-small cell lung
cancer (NSCLC) who are resistant to crizotinib. This designation is
based on results from the ongoing Phase 1/2 trial that show
sustained anti-tumor activity of AP26113 in patients with ALK+
NSCLC, including patients with active brain metastases.
“We are very pleased that the FDA has granted Breakthrough
Therapy designation to AP26113,” stated Harvey J. Berger, M.D.,
chairman and chief executive officer of ARIAD. “We are encouraged
by the clinical data on AP26113 that were presented recently at the
European Cancer Congress, particularly in patients whose tumor had
spread to the brain. We are focused on accelerating patient
enrollment in the ongoing ALTA trial and on planning a front-line
trial of AP26113 in treatment-naive patients.”
Phase 1/2 Data
Updated clinical data from the Phase 1/2 trial of AP26113 were
recently shared at the 2014 European Cancer Congress. A total of
137 patients have been enrolled in the trial in the United States
and Europe. Objective responses were observed in ALK+ NSCLC
patients, and responses were observed in patients who were either
TKI-naïve or resistant to crizotinib. Of the 72 ALK+ NSCLC patients
evaluable for response, 52 (72%) demonstrated an objective
response. The median duration of response was 49 weeks, and the
median progression-free survival (PFS) was 56 weeks. In a subgroup
analysis, 10 of 14 (71%) ALK+ NSCLC patients with active, untreated
or progressing, brain metastases had evidence of radiographic
improvement in those metastases. Of the seven evaluable TKI-naïve
ALK+ NSCLC patients treated with AP26113, all demonstrated an
objective response, including two complete responses (CR).
The most common adverse events (AEs), regardless of treatment
relationship and including all grades, were nausea (45%), diarrhea
(37%), and fatigue (37%). Adverse events, grade 3 or higher,
occurring in three or more patients were dyspnea (4%), increased
lipase (4%), hypoxia (4%), fatigue (3%), alanine aminotransferase
(ALT) increased (2%) and amylase increased (2%). Serious AEs, all
causality, occurring in three or more patients were dyspnea (7%),
pneumonia (5%), hypoxia (4%), neoplasm progression (4%), pyrexia
(2%) and pulmonary embolism (2%).
The 2012 Food and Drug Administration Safety and Innovation Act
(FDASIA) established the Breakthrough Therapy designation to
expedite the development and review of new drugs with preliminary
clinical evidence demonstrating that they may offer a substantial
improvement over available therapies for patients with serious or
life-threatening diseases. The Breakthrough Therapy designation is
a distinct status from both accelerated approval and priority
review, which can also be granted to the same drug if relevant
criteria are met. As of September 3, 2014, FDA listed 213 total
requests for Breakthrough Designation, and 61 requests were
granted. Approximately 41% of the designated products are in
cancer. (http://www.focr.org/breakthrough-therapies).
About Non-Small Cell Lung Cancer and ALK
Non-small cell lung cancer (NSCLC) is the most common form of
lung cancer, accounting for approximately 85 percent of the
estimated 228,190 new cases of lung cancer diagnosed each year in
the United States, according to the American Cancer Society.
Anaplastic lymphoma kinase (ALK) was first identified as a
chromosomal rearrangement in anaplastic large-cell lymphoma (ALCL).
Genetic studies indicate that abnormal expression of ALK is a key
driver of certain types of NSCLC as well. Since ALK is generally
not expressed in normal adult tissues, it represents a highly
promising molecular target for cancer therapy. Approximately three
to eight percent of patients with NSCLC have the ALK gene
mutation.
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).
This press release contains “forward-looking statements”
including, but not limited to, statements relating to preclinical
and clinical data for AP26113 and its development plan.
Forward-looking statements 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 risks and uncertainties include, but are not
limited to, preclinical data and early-stage clinical data that may
not be replicated in later-stage clinical studies, the costs
associated with our research, development, manufacturing and other
activities, the initiation, conduct, timing and results of
pre-clinical and clinical studies of our product candidates, the
adequacy of our capital resources and the availability of
additional funding, and other factors detailed in the Company's
public filings with the U.S. Securities and Exchange Commission.
The information contained in this press release is believed to be
current as of the date of original issue. The Company does not
intend to update any of the forward-looking statements after the
date of this document to conform these statements to actual results
or to changes in the Company's expectations, except as required by
law.
ARIAD Pharmaceuticals, Inc.For InvestorsKendra Adams,
617-503-7028Kendra.adams@ariad.comorFor MediaLiza Heapes,
617-621-2315Liza.heapes@ariad.com
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