AVEO Oncology Announces Publication of Long-term Follow-up Results from TIVO-1 Extension Study (Study 902) in TKI Refractory ...
March 21 2018 - 4:05PM
Business Wire
Results Published in the European
Journal of Cancer
AVEO Oncology (NASDAQ: AVEO) today announced the publication of
long-term follow-up results from Study 902, where patients were
treated with tivozanib (FOTIVDA®) as second-line treatment in
advanced renal cell carcinoma (aRCC), in the European Journal of
Cancer. The publication, titled “Efficacy of Tivozanib Treatment
after Sorafenib in Patients with Advanced Renal Cell Carcinoma:
Crossover of a Phase 3 Study,” was published online first and is
available here. Tivozanib is an oral, once-daily, potent and highly
selective vascular endothelial growth factor receptor tyrosine
kinase inhibitor (VEGFR-TKI).
In Study 902, a total of 161 patients with aRCC received
tivozanib as second-line treatment subsequent to disease
progression on sorafenib in the Phase 3 TIVO-1 study. As previously
reported, median progression-free survival and median overall
survival were 11.0 months and 21.6 months, respectively. Overall
response rate was 18% and stable disease was 52% for an overall
disease control rate of 70%. Tivozanib was generally well
tolerated, with adverse events consistent with those observed in
previous tivozanib trials. The activity shown in TKI refractory
patients compares favorably with data published for other TKI
agents in a similar population.
“Publication of Study 902 underscores the activity of tivozanib
in the refractory setting, with evidence of encouraging clinical
responses, disease control and overall survival outcomes in
patients previously treated with a VEGFR TKI,” said Michael Needle,
M.D., chief medical officer of AVEO. “We believe these efficacy and
safety findings in refractory patients support the rationale for
our ongoing Phase 3 TIVO-3 study. We anticipate that the results of
the TIVO-3 study, together with the results of the previously
completed TIVO-1 trial of tivozanib in the first-line treatment of
aRCC, will serve as a key component for a potential regulatory
approval of tivozanib in the U.S. as a first- and third-line
treatment for aRCC. When completed, TIVO-3 will be among the only
large randomized datasets in third-line disease, a sizable and
growing treatment segment thanks to advances in earlier lines of
treatment, and in patients progressing on prior immunotherapy.
Based on the current rate of progression-free survival events, we
expect top-line results from this study to read out in the second
quarter of this year.”
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 (aRCC) 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 models, enabling
potentially enhanced activity when used in combination with immune
modulating therapy. As part of a North American registration plan,
tivozanib is currently being studied in the Phase 3 TIVO-3 trial, a
randomized, controlled, multi-center, open-label study to compare
tivozanib to sorafenib in subjects with refractory advanced RCC.
Tivozanib has been investigated in several tumors types, including
renal cell, hepatocellular, 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. AVEO 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 (aRCC) in the European
Union plus Norway and Iceland. For more information, please visit
AVEO’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
seeking and obtaining U.S. Food and Drug Administration (FDA)
approval of tivozanib as a first- and third-line treatment for
aRCC; the expected timeline for further EU reimbursement decisions
as well as reporting data from TIVO-3 clinical trial; and AVEO’s
strategy, prospects, plans and objectives. 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, including 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 trials; 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 quarterly and annual
reports on file with the Securities and Exchange Commission,
including its Annual Report on Form 10K for the year ended December
31, 2017, 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.
References
1. Fotivda (Tivozanib) SmPC August 20172. Motzer RJ, Nosov D,
Eisen T, et al. J Clin Oncol 2013; 31(30): 3791-9.
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AVEO:Argot PartnersDavid Pitts,
212-600-1902aveo@argotpartners.com
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