UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of The Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): September
27, 2014
ARIAD
Pharmaceuticals, Inc.
(Exact
name of registrant as specified in its charter)
Delaware
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001-36172
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22-3106987
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(State
or other jurisdiction
of
incorporation)
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(Commission
File
Number)
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(I.R.S.
Employer
Identification
No.)
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26 Landsdowne Street, Cambridge, Massachusetts
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02139
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(Address of principal executive offices)
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(Zip Code)
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Registrant's telephone number, including
area code: (617) 494-0400
Not
Applicable
(Former
name or former address, if changed since last report)
Check the
appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any
of the following provisions (see General Instruction A.2.
below):
⃞
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
⃞
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
⃞
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
⃞
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
ITEM 8.01 Other Events.
On September 29, 2014, ARIAD Pharmaceuticals, Inc. (the “Company”)
issued a press release announcing data presented at the 2014 European
Cancer Congress (the 39th ESMO, 33rd ESTRO, 18th ECCO conference) held
in Madrid, Spain. This press release detailed updated clinical results
on its investigational tyrosine kinase inhibitor (TKI), AP26113, in
patients with advanced non-small cell lung cancer (NSCLC) from an
ongoing Phase 1/2 trial. These study results show sustained anti-tumor
activity of AP26113 in patients with anaplastic lymphoma kinase (ALK)
positive NSCLC, including patients with active brain metastases. The
updated Phase 1/2 trial now contains more mature data of AP26113,
including increasing depth and durability of response in ALK+ NSCLC
patients, as well as additional safety data.
ITEM 9.01 Financial Statements and Exhibits
(d) The following exhibit is filed with this report:
Exhibit Number
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Description
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99.1
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Press Release dated September 29, 2014.
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The press releases contain hypertext links to information on our website
and/or other websites. The information on our website and any other
website is not incorporated by reference into this Current Report on
Form 8-K and does not constitute a part of this Form 8-K.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
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ARIAD Pharmaceuticals, Inc.
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By:
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/s/ Edward M. Fitzgerald
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Edward M. Fitzgerald
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Executive Vice President, Chief Financial Officer
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Date:
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September 29, 2014
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3
Exhibit 99.1
ARIAD
Presents Updated Clinical Data on AP26113 in Patients with ALK+
Non-Small Cell Lung Cancer
MADRID & CAMBRIDGE, Mass.--(BUSINESS WIRE)--September 29, 2014--ARIAD
Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced updated clinical
results on its investigational tyrosine kinase inhibitor (TKI), AP26113,
in patients with advanced non-small cell lung cancer (NSCLC) from an
ongoing Phase 1/2 trial. These study results show sustained anti-tumor
activity of AP26113 in patients with anaplastic lymphoma kinase (ALK)
positive NSCLC, including patients with active brain metastases. The
updated Phase 1/2 trial now contains more mature data of AP26113,
including increasing depth and durability of response in ALK+ NSCLC
patients, as well as additional safety data.
The updated results were presented on Saturday, September 27 at the 2014
European Cancer Congress (the 39th ESMO, 33rd ESTRO, 18th ECCO
conference) held in Madrid, Spain.
Phase 1/2 Study Design
A total of 137 patients have been enrolled in the ongoing Phase 1/2
trial in the United States and Europe. The objectives of the Phase 1
portion of the trial were to characterize the safety and tolerability of
AP26113, pharmacokinetics, and preliminary anti-tumor activity and to
determine the recommended dose for further study of AP26113 in
subsequent clinical trials. The trial used an open-label,
dose-escalating design.
The Phase 2 portion of the trial consists of five expansion cohorts. The
data presented at ESMO focus on the 79 patients with a history of ALK+
NSCLC tumors in the entire trial. Fifty-six of these patients currently
remain on study treatment.
“The updated data from the ongoing trial continue to demonstrate the
anti-tumor activity of AP26113 in patients with crizotinib-resistant ALK
rearranged NSCLC, as well as TKI-naïve ALK rearranged NSCLC,” stated
Scott N. Gettinger, M.D., associate professor of medicine at Yale School
of Medicine. “One of the distinguishing features of the data is the
evidence for anti-tumor activity in the brain, a common site of
treatment failure.”
Key data from the study include:
Safety and Tolerability – All Patients Enrolled
-
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%).
-
Early onset pulmonary symptoms were observed in 13 of 137 (10%)
patients enrolled in the study and occurred more frequently with
starting doses of 180 mg per day and higher compared to the lower
starting doses. These symptoms occurred within 7 days of treatment
initiation, and in some cases, included dyspnea, hypoxia, and new
pulmonary opacities on chest imaging.
-
To minimize the early-onset pulmonary symptoms observed, two
additional dosing regimens were examined in the Phase 2 portion of the
trial: 90 mg per day for 1 week followed by 180 mg per day (n=32) and
90 mg per day continuously (n=18). The incidence of early-onset
pulmonary symptoms in these two dosing regimens was 0 of 32 and 2 of
18 patients, respectively. Overall, 2 out of 50 patients (4%) who
began dosing at 90 mg per day had early-onset pulmonary symptoms and
continued on treatment.
Anti-tumor Activity – ALK+ NSCLC Patients
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Objective responses were observed in ALK+ NSCLC patients at the lowest
dose tested in these patients (60 mg), 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 “waterfall plot” analysis
demonstrated tumor shrinkage in nearly all ALK+ NSCLC patients, with
16 patients experiencing 100% shrinkage of the target lesion. The
median duration of response was 49 weeks, and the median
progression-free survival (PFS) was 56 weeks.
-
Of the seven evaluable TKI-naïve ALK+ NSCLC patients treated with
AP26113, all demonstrated an objective response, including two
complete responses (CR).
-
Of the 65 evaluable ALK+ NSCLC patients with prior crizotinib therapy
treated with AP26113, 45 (69%) demonstrated an objective response.
Median progression-free survival was 47.3 weeks.
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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. Four of these patients
demonstrated a CR by independent review. Of the 10 patients who
responded, six remain on study, with treatment durations up to 105
weeks. In addition, improvement in a patient with leptomeningeal
metastasis was observed.
Pivotal Phase 2 Trial Enrolling Patients
A separate, pivotal global Phase 2 trial of AP26113 in patients with
locally advanced or metastatic NSCLC who were previously treated with
crizotinib is open and enrolling patients. The ALTA (ALK in Lung
Cancer Trial of AP26113) trial is designed to determine
the safety and efficacy of AP26113 in refractory ALK+ NSCLC patients.
The trial will enroll approximately 220 patients including those with
brain metastasis. Patients will be randomized 1:1 to receive either 90
mg of AP26113 once per day continuously or a lead-in dose of 90 mg per
day for 7 days followed by 180 mg once per day continuously.
“We anticipate full patient enrollment in the ALTA trial in the third
quarter of next year,” stated Frank G. Haluska, M.D., Ph.D., senior vice
president of clinical research and development and chief medical officer
at ARIAD. “Based on the continued responses seen in the ongoing Phase
1/2 trial of AP26113, and in particular, the 100% response rate and
durability of response in the TKI-naïve patients, we
are also actively planning a clinical trial to evaluate the potential of
AP26113 in the newly diagnosed ALK+ lung cancer setting.”
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 the updated clinical data for
AP26113. 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 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.
CONTACT:
ARIAD Pharmaceuticals, Inc.
For Investors
Kendra
Adams, 617-503-7028
Kendra.adams@ariad.com
or
For
Media
Liza Heapes, 617-620-4888
Liza.heapes@ariad.com
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