Positive Phase 2 Clinical Data with Tivantinib in Hepatocellular Carcinoma to Be Highlighted in Oral Presentation at 2012 Annual Meeting of American Society of Clinical Oncology
WOBURN, Mass. & TOKYO--(BUSINESS WIRE)--
ArQule, Inc. (Nasdaq: ARQL) and Daiichi Sankyo, Co., Ltd. (TSE 4568)
today announced that an oral presentation at the Annual Meeting of the
American Society of Clinical Oncology (ASCO) will feature Phase 2 trial
data with tivantinib as a single agent investigational second-line
treatment in hepatocellular carcinoma (HCC). ArQule announced that this
randomized, double-blind study met its primary endpoint in January and
will now present the full results from this trial, including positive
data in the pre-defined c-MET high population. Additional clinical data
with tivantinib will be featured in two poster discussions and two
general poster sessions. Abstracts of these presentations with
tivantinib have been published on www.asco.org.
"These findings represent the first randomized data reported with an
investigational c-MET inhibitor administered as a single agent
second-line treatment in HCC," said Paolo Pucci, chief executive officer
of ArQule. "They clearly define c-MET high patients as a biological
subgroup for potential targeted therapy with tivantinib. The robust
statistical significance achieved in this trial reflects the anti-cancer
activity of tivantinib alone and expands its therapeutic potential."
HCC Trial Summary: c-MET high patients
Data from the HCC trial demonstrated a statistically significant
improvement in time-to-progression (HR=0.43, log rank p-value=0.03),
accompanied by significant improvements in progression-free survival and
disease control rate among second-line patients with c-MET high tumors
who were treated with tivantinib. In addition, overall survival data
were observed favoring tivantinib-treated patients in this population.
Efficacy was similar in the two tivantinib dosing subgroups (360
milligrams twice daily and 240 milligrams twice daily), with less
frequent neutropenia in the lower dose.
Previously announced top-line data from the HCC trial demonstrate that
treatment with tivantinib produced a statistically significant 56
percent improvement in TTP in the intent-to-treat (ITT) population by
central radiology review, the primary endpoint (HR = 0.64, log rank
p-value = 0.04) in this trial. Adverse events were reported at similar
rates in the treatment and placebo arms, except for a higher incidence
of fatigue and hematologic events, including neutropenia and anemia, in
tivantinib-treated patients. The incidence of hematologic events
declined following dose reduction of tivantinib from 360 milligrams
twice daily to 240 milligrams twice daily.
The schedule of this and other presentations of data with tivantinib is
provided below. All times are Central Daylight Time.
Oral Presentation
Date and time: Saturday, June 2, 2012, 5:00 PM — 5:15 PM
Abstract
number: 4006
Poster title: Tivantinib (ARQ 197) versus placebo in
patients (Pts) with hepatocellular carcinoma (HCC) who failed one
systemic therapy: Results of a randomized controlled phase II trial (RCT)
Presenter:
Lorenza Rimassa, MD
Location: E Hall D1
Poster Discussion Sessions
Date and time: Saturday, June 2, 2012, 8:00 AM — 12:00 PM
Abstract
number: 4545
Poster title: Safety and efficacy of MET inhibitor
tivantinib (ARQ 197) combined with sorafenib in patients (pts) with
renal cell carcinoma (RCC) from a phase 1 study
Poster board # 24
Presenter:
Igor Puzanov, MD
Location: E450a
Date and time: Saturday, June 2, 2012, 1:15 PM — 5:15 PM
Abstract
number: 8519
Poster title: Safety and efficacy of MET inhibitor
tivantinib (ARQ 197) combined with sorafenib in patients (pts) with NRAS
wild-type or mutant melanoma from a phase 1 study
Poster board # 8
Presenter:
Julie A. Means-Powell, MD
Location: E450b
General Poster Session
Date and time: Monday, June 4, 2012, 8:00 AM — 12:00 PM
Abstract
number: 4117
Poster title: Safety and efficacy of MET inhibitor
tivantinib (ARQ 197) combined with sorafenib in patients (pts) with
hepatocellular carcinoma (HCC) from a phase 1 study
Poster board #
50D
Presenter: Robert E. Martell, MD, PhD
Location: S Hall A2
Date and time: Monday, June 4, 2012, 8:00 AM — 12:00 PM
Abstract
number: 4082
Poster title: A phase II study of tivantinib
monotherapy in patients with previously treated advanced or recurrent
gastric cancer
Poster board # 46A
Presenter: Kei Muro, MD
Location:
S Hall A2
Tivantinib is currently in Phase 3 development and has not yet been
approved for any indication.
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 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 c-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 and early stage 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, 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 the ArQule's drug development and other activities, see
the ArQule's periodic reports filed with the Securities and Exchange
Commission. Neither ArQule, nor Daiichi Sankyo undertake any
obligation to publicly update any forward-looking statements.
ArQule, Inc.
William B. Boni, 781-994-0300
VP, Investor
Relations/Corp. Communications
www.ArQule.com
or
Daiichi
Sankyo, Co., Ltd.
Dr. Michaela Paudler-Debus, +81-3-6225-1338
(office)
Source: ArQule, Inc.
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