AVEO Announces TIVO-3 Passes The First Safety Monitoring Committee Safety Review
February 23 2017 - 6:00AM
Business Wire
AVEO Oncology (NASDAQ:AVEO) today announced that its pivotal,
Phase 3 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 successfully
completed the first safety review by the study’s Safety Monitoring
Committee (SMC). The SMC concluded that no safety concern was
observed for tivozanib and recommended that the study replace the
small number of patients who dropped out prior to starting
treatment.
As recently announced, the TIVO-3 trial is enrolling
substantially ahead of schedule, and with the SMC recommendation to
replace early dropouts the Company still expects to complete
enrollment in June 2017, ahead of its prior guidance of August
2017. A pre-planned futility analysis of the trial is expected
around midyear 2017, with topline data expected in the first
quarter of 2018. The TIVO-3 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 first and third line treatment for RCC.
“Tivozanib is a unique molecule in that its high selectivity for
VEGF is designed to reduce off target toxicity, thereby increasing
tolerability and its combinability with other agents, such as
immunotherapies,” said Michael Needle, M.D., chief medical officer
of AVEO. “We are very pleased to see the pace at which TIVO-3 is
enrolling, and that it has completed its first safety review. We
look forward to the futility analysis around midyear, and to other
potential achievements in our tivozanib clinical program, including
the expected first patient treated in the tivozanib and Opdivo®
combination study, TiNivo, in early March.”
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 the TIVO-3 Trial
The Phase 3 TIVO-3 trial is a pivotal, randomized, controlled,
multi-center, open-label study to compare tivozanib to sorafenib in
subjects with refractory advanced renal cell carcinoma (RCC). The
trial is expected to enroll approximately 322 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. The TIVO-3 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.
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 non-oncologic indications worldwide
and oncology indications outside of North America, as well as to
progress 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 plans to open clinical trial
sites and begin dosing patients in the TiNIVO trial in March 2017,
and the potential advancement of such trial; plans and strategies
of AVEO and its partners and the potential achievement by AVEO and
its partners of clinical, regulatory, commercial, manufacturing and
other development goals and milestones; 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; AVEO's 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/20170223005480/en/
Argot PartnersDavid Pitts,
212-600-1902aveo@argotpartners.com
AVEO Pharmaceuticals (NASDAQ:AVEO)
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