DMC Recommends Discontinuation of Study for Futility
No Unexpected Safety Findings from Interim Analysis
WOBURN, Mass. & TOKYO--(BUSINESS WIRE)--
ArQule, Inc. (Nasdaq: ARQL) and Daiichi Sankyo, Co., Ltd. (TSE 4568)
today announced that the independent Data Monitoring Committee (DMC) of
the Phase 3 MARQUEE (Met inhibitor ARQ 197 plus Erlotinib
vs Erlotinib plus placebo in NSCLC) trial recommended the study
be stopped early following a planned interim analysis, when they
concluded that the study would not meet its primary endpoint of improved
overall survival. Although the interim analysis showed a statistically
significant improvement in progression-free survival (PFS) in the
intent-to-treat (ITT) population, this benefit did not carry over to
overall survival. There were no safety concerns identified by the DMC to
Daiichi Sankyo or ArQule during this interim analysis.
MARQUEE is a randomized, double-blind, controlled pivotal trial to
evaluate the investigational selective MET inhibitor, tivantinib (ARQ
197), in combination with erlotinib in previously treated patients with
locally advanced or metastatic, non-squamous NSCLC.
ArQule and Daiichi Sankyo are providing information regarding the study
discontinuation to health authorities and those clinical investigators
participating in studies of tivantinib. Data from this study will be
presented at an upcoming scientific meeting.
"We are disappointed that the MARQUEE trial did not provide
statistically significant results for overall survival in a disease and
treatment setting which remains a major unmet medical need," said Paolo
Pucci, chief executive officer of ArQule.
"Fighting cancer is a complex process in that therapies work differently
in different tumor settings, so we will continue to investigate
tivantinib in other tumor types," said Glenn Gormley, MD, PhD, global
head, R&D and senior executive officer, Daiichi Sankyo Co., Ltd.
Approximately 1,000 patients were recruited in MARQUEE from more than
200 clinical sites worldwide. The primary endpoint in the trial is
overall survival (OS) in the overall intent-to-treat population.
Secondary endpoints include OS in the subpopulation of patients with
epidermal growth factor receptor (EGFR) wild type, progression-free
survival (PFS) in the ITT population, and further assessment of the
safety of tivantinib in combination with erlotinib. Tivantinib has not
been approved for any indication in any country.
In December 2008, ArQule and Daiichi Sankyo signed a license,
co-development and co-commercialization agreement to co-develop
tivantinib in the U.S., Europe, South America and the rest of the world,
excluding Japan, China (including Hong Kong), South Korea and Taiwan.
ArQule Conference Call and Webcast
A replay of the conference call will be available for seven days
following the call and can be accessed by dialing toll-free (855)
859-2056 and outside the U.S. (404) 537-3406. The replay access code is
ArQule is a biotechnology company engaged in the research and
development of next-generation, small-molecule cancer therapeutics. The
Company's targeted, broad-spectrum products and research programs are
focused on key biological processes that are central to human cancers.
ArQule's lead product candidate, in Phase 2 and Phase 3 clinical
development together with development and commercialization partner,
Daiichi Sankyo, Co. Ltd., is tivantinib, an oral, selective inhibitor of
the MET receptor tyrosine kinase. The Company's pipeline consists of ARQ
621, designed to inhibit the Eg5 kinesin motor protein, and ARQ 736,
designed to inhibit the RAF kinases. ArQule's current discovery efforts,
which are based on the ArQule Kinase Inhibitor Platform (AKIP™), are
focused on the identification of novel kinase inhibitors that are
potent, selective and do not compete with ATP (adenosine triphosphate)
for binding to the kinase.
About Daiichi Sankyo
The Daiichi Sankyo Group is dedicated to the creation and supply of
innovative pharmaceutical products to address the diversified, unmet
medical needs of patients in both mature and emerging markets. While
maintaining its portfolio of marketed pharmaceuticals for hypertension,
hyperlipidemia, and bacterial infections, the Group is engaged in the
development of treatments for thrombotic disorders and focused on the
discovery of novel oncology and cardiovascular-metabolic therapies.
Furthermore, the Daiichi Sankyo Group has created a "Hybrid Business
Model," which will respond to market and customer diversity and optimize
growth opportunities across the value chain. For more information,
please visit www.daiichisankyo.com.
This press release contains statements regarding the clinical trials
with tivantinib (ARQ 197) by ArQule and its business partner, Daiichi
Sankyo. These statements are based on the current beliefs and
expectations of both companies, and are subject to risks and
uncertainties that could cause actual results to differ materially. Positive
information about pre-clinical, early stage and interim clinical trial
results does not ensure that later stage or larger scale clinical trials
will be successful. For example, tivantinib may not demonstrate a
promising therapeutic effect; in addition, it may not demonstrate an
appropriate safety profile in current or later stage or larger scale
clinical trials as a result of known or as yet unanticipated side
effects. The results achieved in later stage trials may not be
sufficient to meet applicable regulatory standards or to justify further
development. Problems or delays may arise during clinical trials or in
the course of developing, testing or manufacturing these compounds that
could lead ArQule or its partners to discontinue development. Even
if later stage clinical trials are successful, unexpected concerns may
arise from analysis of data or from additional data. Obstacles
may arise or issues may be identified in connection with review of
clinical data with regulatory authorities. Regulatory authorities may
disagree with ArQule's view of the data or require additional data or
information or additional studies. In addition, the planned
timing of initiation and completion of clinical trials for tivantinib
are subject to the ability of ArQule, Daiichi Sankyo, and Kyowa Hakko
Kirin, a licensee of tivantinib in Asian territories, to enroll
patients, enter into agreements with clinical trial sites and
investigators, and overcome technical hurdles and other issues related
to the conduct of the trials for which each of them is responsible. There
is a risk that these issues may not be successfully resolved. Drug
development involves a high degree of risk. Only a small number of
research and development programs result in the commercialization of a
product. Positive pre-clinical data may not be supported in later
stages of development. Furthermore, ArQule may not have the
financial or human resources to successfully pursue drug discovery in
the future. Moreover, with respect to partnered programs, even if
certain compounds show initial promise, Daiichi Sankyo or Kyowa Hakko
Kirin may decide not to license or continue to develop them, as the case
may be. In addition, Daiichi Sankyo and Kyowa Hakko Kirin have
certain rights to unilaterally terminate their agreements with ArQule.
If either company were to do so, ArQule might not be able to complete
development and commercialization of the applicable licensed products on
its own. For more detailed information on the risks and uncertainties
associated with ArQule's drug development and other activities, see
ArQule's periodic reports filed with the Securities and Exchange
Commission. Neither ArQule nor Daiichi Sankyo undertakes any obligation
to publicly update any forward-looking statements.
William B. Boni, 781-994-0300
Sankyo, Inc. (US)
Tara Camp, 973-944-2393/908-577-4531
Sankyo, Co., Ltd.
Michaela Paudler-Debus, PhD, +81-3-6225-1338
Source: ArQule, Inc.
News Provided by Acquire Media