AVEO Oncology Announces Presentation of Data from Phase 1b/2 Study of Tivozanib in Patients with Advanced Hepatocellular Carc...
January 19 2018 - 02:30PM
Business Wire
Poster Presentation Delivered at the 2018
American Society of Clinical Oncology (ASCO) Gastrointestinal
Cancers Symposium
AVEO Oncology (NASDAQ:AVEO) today announced the presentation of
data from a multicenter, Phase 1b/2 study of FOTIVDA® (tivozanib),
a potent, selective, long half-life inhibitor of all three vascular
endothelial growth factor (VEGF) receptors, in patients with
advanced, unresectable hepatocellular carcinoma (HCC). The data
were presented during a poster session titled, “Phase 1b/2 study of
tivozanib in patients with advanced inoperable hepatocellular
carcinoma” (Abstract #364) at the 2018 American Society of Clinical
Oncology (ASCO) Gastrointestinal Cancers Symposium held January
18-20, 2018 in San Francisco. A copy of the presentation is
available at www.aveooncology.com.
“Advanced HCC represents an area of high unmet need, with the
limited number of currently available therapies often associated
with increased levels of hepatotoxicity, further complicating
effective treatment,” said Michael Needle, MD, chief medical
officer of AVEO. “Findings from this study suggest that low doses
of tivozanib may yield comparable PFS and a favorable response rate
to current first line standards of care for HCC patients, with a
favorable safety profile which may enable therapeutic combinations
with immunotherapy. We expect the clinical investigation of the
combination of VEGF and checkpoint inhibition to be the next
critical step forward for the treatment of HCC. We look forward to
reporting preliminary Phase 2 data from the TiNivo combination
trial of tivozanib and nivolumab in the lead indication of renal
cell cancer at the upcoming ASCO GU conference, and to exploring
options for pursuing similar combinations in HCC.”
The study, designed to evaluate the safety and efficacy of
tivozanib in advanced HCC, enrolled a total of 21 patients at three
study sites. In the Phase 1b portion of the trial, which used a
modified 3+3 dose escalation design, 8 patients were dosed with
tivozanib starting at 1.0 mg daily for 21 days followed by 7 days
off drug, with inter-patient escalation to 1.5 mg daily or
de-escalation to 0.5 mg daily based on cumulative dose-limiting
toxicities (DLT). Upon escalation to 1.5 mg, two patients had on
target dose limiting toxicities (grade 3 mucositis and
hypertension), which were likely due to the high potency of
tivozanib, and came off study without completing the DLT period.
Tivozanib at 1.0 mg daily was selected for the Phase 2 expansion
portion and was well tolerated.
Of 19 evaluable patients, at a median follow up of 16.9 months,
the study’s primary endpoint of median progression-free survival
(PFS) and PFS at week 24 were 5.5 months and 47%, respectively. A
partial response (PR) was seen in 4/19 patients (21%) and stable
disease (SD) in 8/19 patients (42%), for a disease control rate
(DCR) of 63%. Overall survival (OS) at 6 and 12 months was 58% and
25%, respectively, with a median OS of 7.5 months. Notably, 4
patients have maintained SD for over two years. There were no
significant changes in HBV or HCV viral load during study
treatment. Tivozanib was generally well tolerated at 1.0 mg daily,
with adverse events consistent with those observed in previous
tivozanib trials.
The Phase 1b/2 study was one of several studies funded by a
grant provided to the National Comprehensive Cancer Network from
AVEO.
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 with respect to tivozanib
(FOTIVDA®); the expected timeline for reporting data from TIVO-3
and TiNivo; the role and expected benefits of tivozanib and other
VEGF TKIs on a stand-alone basis, or in combination with or
following immunotherapy; 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/20180119005483/en/
AVEO:Argot PartnersDavid Pitts,
212-600-1902aveo@argotpartners.com
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