AVEO Oncology Announces Completion of TIVO-3 Study Futility Analysis with No Changes to Study Protocol
October 05 2017 - 5:30PM
Business Wire
AVEO Oncology (NASDAQ:AVEO) today announced the completion of a
pre-planned futility analysis of the Phase 3 TIVO-3 trial, the
Company’s randomized, controlled, multi-center, open-label study to
compare FOTIVDA® (tivozanib) to sorafenib in subjects with
refractory advanced renal cell carcinoma (RCC). Based on the
results of the futility analysis, which was reviewed by an
independent statistician, the study will continue as planned
without modification. This analysis did not allow for early
stopping due to efficacy to assure adequate follow-up for the key
secondary endpoint of overall survival. The pre-planned futility
analysis was triggered by the reporting of 128 progression events
in early August. Additional events were recorded as part of the
data management process leading into the futility analysis,
resulting in a revised data cut-off date for the analysis of May
29. The Company continues to expect the TIVO-3 to read out 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 a first
and third line treatment for RCC.
“The treatment of advanced renal cell cancer is undergoing rapid
change, with immunotherapy and combination regimens delivering
improved outcomes for patients and shaping a new treatment
paradigm,” said Michael Bailey, president and chief executive
officer of AVEO. “We believe our tivozanib clinical strategy
positions us well in this evolving landscape, with the TIVO-3 study
on track to provide the first post-immunotherapy pivotal datasets
for a VEGF-TKI, and the TiNivo study providing early and
encouraging combination data. We look forward to readout of the
TIVO-3 trial in the first quarter of 2018. We also look forward to
presenting Phase 1 results from the Phase 1/2 TiNivo study of
tivozanib in combination with OPDIVO® at a medical conference this
fall, and to leveraging tivozanib’s unique safety and efficacy
profile in future potential therapy combinations.”
The TIVO-3 trial was designed to enroll 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 are 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 TiNivo trial is a Phase 1/2 study of tivozanib in
combination with Bristol-Myers Squibb’s OPDIVO® (nivolumab), an
immune checkpoint, or PD-1, inhibitor, for the treatment of RCC.
The TiNivo trial is being led by the Institut Gustave Roussy in
Paris under the direction of Bernard Escudier, MD, Chairman of the
Genitourinary Oncology Committee. The trial advanced into the Phase
2 expansion portion following successful completion of the Phase 1
dose escalation portion. The combination was well tolerated to the
full dose and schedule of single agent tivozanib, with no dose
limiting toxicities. The expansion portion of the trial is expected
to enroll an additional 20 subjects. Phase 1 results from the
ongoing study have been submitted for presentation at a scientific
meeting taking place in the fourth quarter.
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 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. 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). Tivozanib
(FOTIVDA®) is approved by the European Commission for the treatment
of adult patients with advanced renal cell carcinoma (RCC) 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: clinical, regulatory and commercial plans
of AVEO and its partner EUSA Pharma to progress the development of
FOTIVDA® (tivozanib); the expected timeline for reporting data from
TIVO-3; the role and expected benefits of tivozanib and other TKIs
on a stand-alone basis, or in combination with or following
immunotherapy; the expected enrollment of the TiNivo trial and
presentation of TiNivo results; expectations about the potential
for additional payments by EUSA Pharma; the value of AVEO's
partnerships in advancing its pipeline; and AVEO’s strategy,
prospects, plans and objectives, including as they pertain
specifically to tivozanib. 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 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 tivozanib. AVEO
faces other risks relating to its business as well, including risks
relating to 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” and “Management’s Discussion and Analysis of Financial
Condition and Results of Operations—Liquidity and Capital
Resources” included in AVEO’s Annual Report on Form 10-K for the
year ended December 31, 2016, its quarterly reports on Form 10-Q
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: http://www.businesswire.com/news/home/20171005006397/en/
AVEO:Argot PartnersDavid Pitts,
212-600-1902aveo@argotpartners.com
AVEO Pharmaceuticals (NASDAQ:AVEO)
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