AVEO Oncology to Present TIVO-3 Data at the 2019 ASCO Genitourinary Cancers Symposium
January 02 2019 - 7:00AM
Business Wire
AVEO Oncology (NASDAQ: AVEO) today announced that data from the
Phase 3 TIVO-3 study of tivozanib (FOTIVDA®) versus sorafenib in
refractory advanced or metastatic renal cell carcinoma (RCC) will
be presented during an oral session at the 2019 American Society of
Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium being
held February 14-16, 2019 in San Francisco.
Presentation Details
Title: TIVO-3: A phase III, randomized, controlled,
multicenter, open-label study to compare tivozanib to sorafenib in
subjects with refractory advanced renal cell carcinoma
(RCC)Presenter: Brian Rini, MD, Cleveland Clinic Lerner
College of Medicine of Case Western Reserve UniversityAbstract
Number: 541Session Title: General Session 8: Evolving
Management of Metastatic Renal Cell CarcinomaData and Time:
February 16, 2019, 10:00 a.m.-11:30 a.m. PT
About Tivozanib (FOTIVDA®)
Tivozanib (FOTIVDA®) is an oral, once-daily, vascular
endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI)
discovered by Kyowa Hakko Kirin and approved for the treatment of
adult patients with advanced renal cell carcinoma (RCC) in the
European Union plus Norway and Iceland. It is a potent, selective
and long half-life inhibitor of all three VEGF receptors and is
designed to optimize VEGF blockade while minimizing off-target
toxicities, potentially resulting in improved efficacy and minimal
dose modifications.1,2 Tivozanib has been shown to significantly
reduce regulatory T-cell production in preclinical models3, and has
demonstrated synergy in combination with nivolumab (anti PD-1) in a
Phase 2 study in RCC. Tivozanib has been investigated in several
tumors types, including renal cell, hepatocellular, colorectal and
breast cancers.
About AVEO
AVEO Pharmaceuticals, Inc. (the “Company” or “AVEO”) is a
biopharmaceutical company dedicated to advancing a broad portfolio
of targeted medicines for oncology and other areas of unmet medical
need. The Company’s strategy is to retain North American rights to
its oncology portfolio while securing partners in development and
commercialization outside of North America. The Company is seeking
to develop and commercialize its lead candidate tivozanib in North
America as a treatment for advanced or metastatic renal cell
carcinoma (“RCC”). The Company has outlicensed tivozanib (FOTIVDA®)
for oncological indications in Europe and other territories outside
of North America. Tivozanib is approved in the European Union, as
well as Norway and Iceland, for the first-line treatment of adult
patients with RCC and for adult patients who are vascular
endothelial growth factor receptor and mTOR pathway inhibitor-naïve
following disease progression after one prior treatment with
cytokine therapy for RCC. The Company has entered into partnerships
for the development and commercialization of AV-203 (CAN017) and
ficlatuzumab, both clinical stage assets in oncology. The Company
is currently seeking a partner to develop the AV-353 platform, a
preclinical asset, worldwide for the potential treatment of
pulmonary arterial hypertension and oncology. In addition, a new
formulation of tivozanib is being explored in ocular conditions.
The Company has recently regained the rights to its AV-380 program
for the potential treatment of cachexia and is considering a
variety of options to advance the program’s development.
For more information, please visit the Company’s website at
www.aveooncology.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of AVEO
that involve substantial risks and uncertainties. All statements,
other than statements of historical fact, contained in this press
release are forward-looking statements. The words “anticipate,”
“believe,” “expect,” “intend,” “may,” “plan,” “potential,” “could,”
“should,” “would,” “seek,” “look forward,” “advance,” “goal,”
“strategy,” or the negative of these terms or other similar
expressions, are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. These forward-looking statements include, among
others, statements about: AVEO’s plans to present data from the
TIVO-3 study in the first half of 2019, including updated overall
survival data; AVEO’s plans and timing estimates regarding the
potential submission of a New Drug Application to the FDA for
tivozanib in the first half of 2019; AVEO’s plans and strategies
for commercialization of tivozanib in the United States and Europe;
the potential for tivozanib in RCC and other indications, such as
ocular conditions, and as either a monotherapy or combination
therapy; AVEO’s plan to seek a partner to develop the AV-353
platform; AVEO’s plans regarding AV-380; AVEO’s cash runway; and
AVEO’s strategy, prospects, plans and objectives, including its
plans to advance its portfolio of targeted medicines. AVEO has
based its expectations and estimates on assumptions that may prove
to be incorrect. As a result, readers are cautioned not to place
undue reliance on these expectations and estimates. Actual results
or events could differ materially from the plans, intentions and
expectations disclosed in the forward-looking statements that AVEO
makes due to a number of important factors, including risks
relating to AVEO’s ability to enter into and maintain its third
party collaboration and license agreements, and its ability, and
the ability of its collaborators, licensees, and other strategic
partners, to achieve development and commercialization objectives
under these arrangements; and AVEO’s ability, and the ability of
its licensees, to demonstrate to the satisfaction of applicable
regulatory agencies such as the FDA the safety, efficacy and
clinically meaningful benefit of AVEO’s product candidates,
including tivozanib. AVEO faces other risks relating to its
business as well, including risks relating to the timing and costs
of any product candidate seeking and obtaining regulatory approval;
AVEO’s ability to file an NDA for tivozanib in the timeframe it
currently estimates or at all; AVEO’s and its collaborators’
ability to successfully enroll and complete clinical trials; AVEO’s
ability to achieve and maintain compliance with regulatory
requirements applicable to its product candidates; AVEO’s ability
to obtain and maintain adequate protection for intellectual
property rights relating to its product candidates and
technologies; AVEO’s ability to successfully implement its
strategic plans; AVEO’s ability to raise the substantial additional
funds required to achieve its goals, including those goals
pertaining to the development and commercialization of tivozanib;
unplanned capital requirements; adverse general economic and
industry conditions; competitive factors; and those risks discussed
in the sections titled “Risk Factors” and “Management’s Discussion
and Analysis of Financial Condition and Results of
Operations—Liquidity and Capital Resources” included in AVEO’s
quarterly and annual reports on file with the Securities and
Exchange Commission (SEC) and in other filings that AVEO may make
with the SEC in the future. The forward-looking statements in this
press release represent AVEO’s views as of the date of this press
release, and subsequent events and developments may cause its views
to change. While AVEO may elect to update these forward-looking
statements at some point in the future, it specifically disclaims
any obligation to do so. You should, therefore, not rely on these
forward-looking statements as representing AVEO’s views as of any
date other than the date of this press release. Any reference to
AVEO’s website address in this press release is intended to be an
inactive textual reference only and not an active hyperlink.
References1. Fotivda (Tivozanib) SmPC August 20172.
Motzer RJ, Nosov D, Eisen T, et al. J Clin Oncol 2013; 31(30):
3791-9.3. Pawlowski N et al. AACR 2013. Poster 3971.
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AVEO Contact:David Pitts, Argot Partners(212)
600-1902aveo@argotpartners.com
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