AVEO Oncology Issues Statement Regarding Revised TIVO-3 Trial Guidance
July 19 2018 - 6:30AM
Business Wire
AVEO Oncology (NASDAQ: AVEO) today issued the following
statement regarding its recently revised guidance on the timing of
topline data from the TIVO-3 study, its Phase 3 trial of tivozanib
as a third-line treatment for advanced renal cell carcinoma.
“The Company expects to report topline results from the TIVO-3
study in the fourth quarter of 2018, approximately 6-8 weeks after
the trial records 255 progression free survival (PFS) events. This
change in guidance from the third quarter of 2018 is the result of
PFS events occurring slower than forecasted, combined with ten
patients being removed or ‘censored’ from the PFS event count. The
one-time adjustment in the event count is the result of an
administrative error that occurred from counting, as PFS events,
the deaths of ten patients who had left the study without
documented radiographic progression. These deaths will be counted
only as overall survival (OS) events. Per regulatory guidance and
the TIVO-3 protocol, among patients who leave the study without
documented disease progression, only those who die within eight
weeks of their last study assessment and have not started another
therapy can be counted as a PFS event. Following the adjustment,
and as of yesterday, the PFS event count is 243.”
“Study data remains blinded to the Company and no changes in
study assumptions have been made. The administrative error was
discovered as part of the data cleaning and review process. The
data review process was initiated in an effort to shorten the data
analysis period between reaching the 255 PFS events (database lock)
and the announcement of topline data. By correcting the
administrative error prior to database lock, the intended
statistical powering of the study has been unaffected. The Company
plans to announce when 255 PFS events have occurred and the topline
data analysis for the trial has been initiated.”
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 other areas of unmet
medical need. Tivozanib (FOTIVDA®) is approved by the European
Commission for the treatment of adult patients with advanced renal
cell carcinoma in the European
Union plus Norway and Iceland. 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: the Company’s plans and prospects for
advancing its lead development programs, including its expectations
regarding the timing for top line results from the Phase 3 TIVO-3
study of tivozanib in aRCC; advancement of AVEO’s pipeline; and
AVEO’s strategy, prospects, plans and objectives, including as they
pertain specifically to tivozanib and leveraging partnerships. 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 its
and its collaborators’ 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
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” 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. 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: https://www.businesswire.com/news/home/20180719005235/en/
AVEO:Argot PartnersDavid Pitts,
212-600-1902aveo@argotpartners.com
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