- ArQule to host investor conference call
on February 17, 2017 at 8:30 A.M. ET
ArQule, Inc. (Nasdaq: ARQL) and Daiichi Sankyo today announced
that the METIV-HCC phase 3 study of tivantinib in hepatocellular
carcinoma (HCC) did not meet its primary endpoint of improving
overall survival.
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View the full release here:
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METIV-HCC is a biomarker-selected, double-blind,
placebo-controlled, randomized phase 3 study evaluating tivantinib
(2:1) versus best supportive care in patients with
MET-overexpressing, inoperable HCC intolerant to or
previously-treated with systemic therapy. A total of 340 patients
with MET-overexpressing HCC analyzed by a validated
immunohistochemical assay were randomized in the intent-to-treat
population for efficacy analysis. The primary endpoint of the study
is overall survival. Secondary endpoints include progression-free
survival and safety. Full results from the trial will be presented
at an upcoming scientific forum.
“HCC is a disease with high unmet need, especially in the
second-line setting, so these results are disappointing for the
patients as well as the investigators and the companies,” said
Paolo Pucci, Chief Executive Officer of ArQule.
“Despite the negative outcome of this study, we remain committed
to applying rigorous science to unmet needs for patients with
cancer,” said Antoine Yver, MD, MSc, Executive Vice President and
Global Head, Oncology Research and Development, Daiichi Sankyo. “We
would like to take this opportunity to thank all of the
investigators, and especially the patients, for their participation
in this study.”
The ArQule investor conference call can be accessed in the
“Investors and Media” section of ArQule’s website, www.arqule.com,
under “Events and Presentations.” You may also listen to the call
by dialing (877) 868-1831 within the U.S. or (914) 495-8595 outside
the U.S. and using the passcode 74015633. A replay will be
available two hours after the completion of the call and can be
accessed in the “Investors and Media” section of our website,
www.arqule.com, under “Events and Presentations.”
About Hepatocellular Carcinoma (HCC)Liver cancer is the
sixth most common cancer globally with 782,000 new cases in 2012
and is the second most common cause of cancer-related death with
745,000 deaths in 2012.1 HCC accounts for about 90 percent of
primary liver cancers.2 Cirrhosis, chronic hepatitis B and C
and smoking are recognized worldwide as factors increasing the risk
of HCC.2
About Tivantinib (ARQ 197)ArQule and Daiichi Sankyo have
a licensing, co-development and co-commercialization agreement for
tivantinib in the U.S., Europe, South America and the rest of the
world, excluding Japan, China (including Hong Kong), South Korea
and Taiwan.
About ArQuleArQule is a biopharmaceutical company engaged
in the research and development of targeted therapeutics to treat
cancers and rare diseases. Our mission is to discover, develop and
commercialize novel small molecule drugs in areas of high unmet
need that will dramatically extend and improve the lives of our
patients. Our clinical-stage pipeline consists of five drug
candidates, all of which are in targeted, biomarker-defined patient
populations, making ArQule a leader among companies our size in
precision medicine. ArQule’s lead product, in phase 3 clinical
development, is tivantinib (ARQ 197), an oral, selective inhibitor
of the c-MET receptor tyrosine kinase, for second-line treatment of
patients with MET-overexpressing hepatocellular carcinoma in
partnership with Daiichi Sankyo in the West and Kyowa Hakko Kirin
in Asia. ArQule’s proprietary pipeline includes: ARQ 087, a
multi-kinase inhibitor designed to preferentially inhibit the
fibroblast growth factor receptor (FGFR) family, in phase 2 for
iCCA and in phase 1b for multiple oncology indications; ARQ 092, a
selective inhibitor of the AKT serine/threonine kinase, in phase 1
for multiple oncology indications as well as ultra-rare Proteus
syndrome, in partnership with the National Institutes of Health
(NIH); ARQ 751, a next generation AKT inhibitor, in phase 1 for
patients with AKT1 and PI3K mutations; and ARQ 761, a β-lapachone
analog being evaluated as a promoter of NQO1-mediated programmed
cancer cell necrosis, in phase 1/2 in multiple oncology indications
in partnership with the University of Texas Southwestern Medical
Center. In addition, we have advanced ARQ 531, an investigational,
orally bioavailable, potent and reversible inhibitor of both wild
type and C481S-mutant BTK, into toxicology testing and plan to file
an Investigational New Drug Application in early 2017. ArQule’s
current discovery efforts are focused on the identification and
development of novel kinase inhibitors, leveraging the Company’s
proprietary library of compounds. You can follow us on Twitter and
LinkedIn.
About Daiichi Sankyo Cancer EnterpriseThe vision of
Daiichi Sankyo Cancer Enterprise is to leverage our world-class,
innovative science and push beyond traditional thinking in order to
create meaningful treatments for patients with cancer. We are
dedicated to transforming science into value for patients, and this
sense of obligation informs everything we do. Anchored by our
Antibody Drug Conjugate (ADC) and Acute Myeloid Leukemia (AML)
franchises, our cancer pipeline includes more than 20 small
molecules, monoclonal antibodies and ADCs stemming from our
powerful research engines: our two laboratories for
biologic/immuno-oncology and small molecules in Japan, and
Plexxikon Inc., our small molecule structure-guided R&D center
in Berkeley, CA. Compounds in development include: quizartinib, an
oral FLT3 inhibitor, for FLT3-ITD+ AML; DS-8201, a HER2-targeting
ADC, for HER2-expressing breast or gastric cancer or other
HER2-expressing solid tumors; pexidartinib, an oral CSF-1R
inhibitor, for tenosynovial giant cell tumor (TGCT), which is also
being explored in a range of solid tumors in combination with the
anti-PD1 immunotherapy, pembrolizumab; and tivantinib, an oral MET
inhibitor, for second-line treatment of patients with
MET-overexpressing hepatocellular carcinoma in partnership with
ArQule, Inc.
About Daiichi SankyoDaiichi Sankyo Group is
dedicated to the creation and supply of innovative pharmaceutical
products to address diversified, unmet medical needs of patients in
both mature and emerging markets. With over 100 years of scientific
expertise and a presence in more than 20 countries, Daiichi Sankyo
and its 16,000 employees around the world draw upon a rich legacy
of innovation and a robust pipeline of promising new medicines to
help people. In addition to a strong portfolio of medicines for
hypertension and thrombotic disorders, under the Group’s 2025
Vision to become a “Global Pharma Innovator with a Competitive
Advantage in Oncology,” Daiichi Sankyo research and development is
primarily focused on bringing forth novel therapies in oncology,
including immuno-oncology, with additional focus on new horizon
areas, such as pain management, neurodegenerative diseases, heart
and kidney diseases, and other rare diseases. For more information,
please visit: www.daiichisankyo.com. Daiichi Sankyo, Inc.,
headquartered in Parsippany, New Jersey, is a member of the Daiichi
Sankyo Group. For more information on Daiichi Sankyo, Inc., please
visit: www.dsi.com.
This press release contains forward-looking statements regarding
the Company's clinical trials with tivantinib (ARQ 197). 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 may not demonstrate promising
therapeutic effect or appropriate safety profiles 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 prior to the initiation of planned clinical trials, during
clinical trials or in the course of developing, testing or
manufacturing that could lead the Company or its partners and
collaborators to fail to initiate or to discontinue development.
Even if later stage clinical trials are successful, unexpected
concerns may arise from subsequent 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 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 is subject to the
ability of the Company as well as Daiichi Sankyo, Inc., our
development partner for tivantinib, 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. In addition, we and our
partners are utilizing companion diagnostic tests to identify
MET-overexpressing patients in the METIV-HCC, JET-HCC and other
trials. We may encounter difficulties in developing and obtaining
approval for companion diagnostics, including issues relating to
selectivity/specificity, analytical validation, reproducibility, or
clinical validation. Any delay or failure by our collaborators or
us to develop or obtain regulatory approval of the companion
diagnostics could delay or prevent approval of our product
candidates. 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, the Company 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 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.
References:1 Ferlay J, et al. Int. J. Cancer.
2015;136:E359-E386.2 Llovet JM, et al. J Hepatol.
2012;56(4):908-43
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version on businesswire.com: http://www.businesswire.com/news/home/20170217005132/en/
ArQule, Inc.Dawn Schottlandt, +1 781-994-0300Sr. Director,
Investor Relations/ Corp.
Communicationsdschottlandt@arqule.comwww.arqule.comorDaiichi
Sankyo, Inc.Jennifer Brennan, +1 973-944-2393 (office)+1
201-709-9309 (mobile)jbrennan2@dsi.com
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