AVEO Oncology Announces Pivotal Phase 3 TIVO-3 Study of Tivozanib in Renal Cell Carcinoma Reaches Enrollment Target
June 20 2017 - 7:00AM
Business Wire
– Pre-planned futility analysis of the trial
expected midyear 2017; topline data expected in the first quarter
of 2018 –
AVEO Oncology (NASDAQ: AVEO) today announced that the Company’s
pivotal TIVO-3 trial, a randomized, controlled, multi-center,
open-label study to compare tivozanib to sorafenib in subjects with
refractory advanced renal cell carcinoma (RCC) has reached its
enrollment target of 322 patients, more than two months ahead of
the Company’s initial guidance. Tivozanib, the Company’s lead
program, is a potent, selective, long half-life inhibitor of all
three vascular endothelial growth factor (VEGF) receptors. A
pre-planned futility analysis of the TIVO-3 trial is expected
around midyear 2017, with topline data expected in the first
quarter of 2018. The trial, together with the previously completed
TIVO-1 trial of tivozanib in the first line treatment of RCC, is
designed to support regulatory approval of tivozanib in the U.S. as
a first and third line treatment for RCC.
“Reaching our enrollment goal for the TIVO-3 trial is a
meaningful milestone for AVEO, which we believe reflects the
support of many individuals within the Company, our medical
partners in the oncology community and the patients we serve,” said
Michael Bailey, president and chief executive officer of AVEO. “As
previously noted, based on a recommendation by the Safety
Monitoring Committee, the study will continue enrolling additional
patients for the next few weeks to replace early dropouts. We look
forward to several key upcoming potential inflection points in the
tivozanib program, including a European regulatory decision and
ongoing enrollment in the TiNivo study, culminating in the readout
of the TIVO-3 trial, expected in the first quarter of 2018.”
The TIVO-3 trial is enrolling patients with recurrent RCC who
have failed at least two prior regimens, including VEGFR-TKI
therapy (other than sorafenib). Eligible patients may also have
received checkpoint inhibitor therapy in earlier lines of
treatment. Patients will be randomized 1:1 to receive either
tivozanib or sorafenib, with no crossover between arms. The primary
endpoint of the study is progression free survival. Secondary
endpoints include overall survival, overall response rate, and
safety and tolerability.
About Tivozanib
Tivozanib is an oral, once-daily, vascular endothelial growth
factor (VEGF) tyrosine kinase inhibitor (TKI). 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. Tivozanib has been investigated in
several tumors types, including renal cell, colorectal and breast
cancers.
About AVEO
AVEO Oncology (AVEO) is a biopharmaceutical company dedicated to
advancing a broad portfolio of targeted therapeutics for oncology
and other areas of unmet medical need. The Company is focused on
seeking to develop and commercialize its lead candidate tivozanib,
a potent, selective, long half-life inhibitor of vascular
endothelial growth factor 1, 2 and 3 receptors, in North America as
a treatment for renal cell carcinoma and other cancers. AVEO is
leveraging multiple partnerships aimed at developing and
commercializing tivozanib in oncology indications outside of North
America, and at progressing its pipeline of novel therapeutic
candidates in cancer and cachexia (wasting syndrome). 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: the expected timelines for completing enrollment,
undergoing a futility analysis and receiving top-line data readouts
in TIVO-3; the potential for the design of the TIVO-3 and TIVO-1
trials to support regulatory approval for first and third line
indications in RCC in the U.S.; AVEO's expectations regarding a
registration decision in the EU for tivozanib and ongoing
enrollment of the TiNivo study; AVEO’s strategy, prospects, plans
and objectives, including those that relate to advancing
therapeutics, including tivozanib; and the potential safety,
efficacy, tolerability and other benefits of tivozanib in the
treatment of renal cell carcinoma as a single agent or in
combination with other therapies. 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
agreements, and its ability, and the ability of its licensees and
other partners, to achieve development and commercialization
objectives under these arrangements; AVEO's ability, and the
ability of its licensees, to demonstrate to the satisfaction of
applicable regulatory agencies the safety, efficacy and clinically
meaningful benefit of AVEO's product candidates, including without
limitation risks relating to the ability of AVEO’s licensee to
successfully obtain approval of its MMA for tivozanib in the EU.
AVEO faces other risks relating to its business as well, including
its ability to successfully enroll and complete clinical trials,
including the TIVO-3 and TiNivo studies; AVEO's ability to achieve
and maintain compliance with all 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; developments, expenses and
outcomes related to AVEO's ongoing shareholder litigation; 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 section
titled "Risk Factors" in AVEO's most recent Annual Report on Form
10-K, its quarterly reports on Form 10-Q and its other filings with
the SEC. The forward-looking statements in this press release
represent AVEO's views as of the date of this press release. AVEO
anticipates that 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170620005233/en/
AVEO:Argot PartnersDavid Pitts,
212-600-1902aveo@argotpartners.com
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