Daiichi
Sankyo and ArQule Announce Top-Line Results of Phase 2 Trial with Tivantinib in
Colorectal Cancer; Tivanitinib didn't meet primary Phase 2 trial endpoint.
Full
press release below.
SOURCE:
TOKYO & WOBURN, Mass.--January 11, 2013 04:30 AM Pacific Time.--Daiichi Sankyo and ArQule announced
the top-line results of a randomized Phase 2 signal generation trial of
tivantinib used in combination with irinotecan and cetuximab in patients with
refractory or relapsed colorectal cancer. Although the trial did not meet its
primary endpoint of Progression-Free Survival, the analysis of the patients
enrolled showed that median PFS was 8.3 months in the experimental arm,
compared with 7.3 months in the control arm. Objective Response Rate a
secondary endpoint, was 45 percent in the experimental arm versus 33 percent in
the control arm but was not statistically significant. The PFS results obtained
in both the control arm and the experimental arm were longer than expected
compared to previously published historical norms. Additional data and analyses
from this trial are planned for presentation at a future medical meeting and
will include mature OS data as well as analyses of patient sub-groups,
biomarker status and regional variability, including pre- and post study treatments.
“We are encouraged by these findings that expand the body of data for
tivantinib in CRC and offer the potential for further exploration,” said
Reinhard von Roemeling, M.S., Vice President, Clinical Development-Oncology,
Daiichi Sankyo. “We plan to continue discussions with key opinion leaders in
the field of CRC to determine how best to proceed with further clinical
development of tivantinib in this tumor type.”
Adverse events were reported at similar rates in the
experimental and control arms, except for increased neutropenia observed in the
experimental arm, with no discontinuations of treatment for this reason. No
treatment-emergent adverse events leading to death were assessed as related to
study treatment. Tivantinib was generally well tolerated in combination with
the doses of cetuximab and irinotecan studied in this trial.
About the Phase 2 Trial
The 122 patients enrolled in this trial (US n=67; Russia n=39;
Western Europe n=16) had unresectable CRC, progressed following first-line
treatment and had tumors expressing the wild-type form of the KRAS gene. The
primary objective of the trial was to assess the contribution of tivantinib to
the irinotecan and cetuximab treatment regimen. The primary endpoint of the
study was PFS, and secondary objectives included OS and ORR. Patients were
randomized to receive tivantinib, 360 milligrams twice daily, plus irinotecan
and cetuximab, or placebo plus irinotecan and cetuximab. The trial was
conducted by Daiichi Sankyo, the co-developer with ArQule of tivantinib in all
regions outside of certain territories in Asia.
Investor Conference Call
ArQule will host an investor conference call today at 9:00 a.m.
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Date:
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Friday, January 11, 2013
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Time:
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9:00 a.m. Eastern Time
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Conference Call
Dial-In Numbers
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Domestic:
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(877) 868-1831
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International:
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(914) 495-8595
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Webcast:
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A replay of the conference call will be available beginning
approximately two hours after its completion for seven days and can be accessed
by dialing toll-free 1-855-859-2056 and 1-404-537-3406 from outside the U.S.
For archived calls, the access code is 88326775.
About Colorectal Cancer (CRC)
Colorectal cancer is the second leading cause of cancer-related
deaths in the U.S. and is the third most common cancer in men and women.
According to the National Cancer Institute, it is estimated that more than
140,000 new cases of colorectal cancer will be diagnosed in 2012, and an
estimated 51,700 deaths from the disease will occur this year. The estimated
incidence rate was 46 per 100,000 people during the period 2005-2009.
About MET and Tivantinib (ARQ 197)
Tivantinib is an orally administered, selective inhibitor of
MET, a receptor tyrosine kinase, which is currently in Phase 2 clinical trials.
In certain healthy adult cells, MET is present in low to normal levels to
support natural cellular function, but in some cancer cells, MET is
inappropriately and continuously activated. When abnormally activated, MET
plays multiple roles in aspects of human cancer, including cancer cell growth,
survival, angiogenesis, invasion and metastasis.
Pre-clinical data have demonstrated that tivantinib inhibits MET
activation in a range of human tumor cell lines and shows anti-tumor activity
against several human tumor xenografts. In clinical trials to date, treatment
with tivantinib has been generally well tolerated and has shown clinical
activity in the tumors studied. Tivantinib has not yet been approved for any
indication in any country.
About ArQule, Inc. and Daiichi Sankyo, Co., Ltd.
On December 19, 2008, ArQule and Daiichi Sankyo, Co., Ltd.
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,
where Kyowa Hakko Kirin Co., Ltd. has exclusive rights for development and
commercialization.
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.
About ArQule
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, in Phase 2 clinical development, is tivantinib (ARQ 197), 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.
This press release contains forward-looking statements regarding
the clinical trials with tivantinib in combination with irinotecan and
cetuximab in colorectal cancer conducted by the Company and Daiichi Sankyo Co.,
Ltd. as well as the Company’s agreement with Daiichi Sankyo. These statements
are based on the Company’s current beliefs and expectations, and are subject to
risks and uncertainties that could cause actual results to differ materially. Positive
information about pre-clinical and early stage clinical trial results does not
ensure that later stage or larger scale clinical trials will be successful. For
example, tivantinib alone or in a combination therapy may not demonstrate
promising therapeutic effects in such trials; in addition, such therapies may
not demonstrate an appropriate safety profiles in later stage or larger scale
clinical trials, including among patients with underlying cirrhosis and
compromised liver function, 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 tivantinib or in obtaining irinotecan and
cetuximab that could lead the Company 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, and regulatory authorities may
disagree with the Company’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 alone or in a
combination therapy is subject to the ability of the Company or Daiichi Sankyo,
its partner, to enroll patients, enter into agreements with clinical trial
sites and investigators, and overcome other technical hurdles and issues
related to the conduct of the trials for which each of them is responsible that
may not be 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, Daiichi Sankyo has certain rights to unilaterally
terminate the tivantinib license, co-development and co-commercialization
agreement. If it were to do so, the Company might not be able to
complete development and commercialization of tivantinib on its own. For more
detailed information on the risks and uncertainties associated with the
Company’s drug development and other activities, see the Company’s periodic
reports filed with the Securities and Exchange Commission. The Company does not
undertake any obligation to publicly update any forward-looking statements.
Contacts
Daiichi Sankyo, Inc. (US)
Tara Camp, 973-944-2393;
or
ArQule,
Inc.
William B. Boni, 781-994-0300
VP, Investor Relations/Corp. Communications
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