AVEO Oncology Announces Publication of Phase 1b/2 Study of Tivozanib in Advanced, Inoperable Liver Cancer in the British Jour...
February 12 2020 - 4:26PM
Business Wire
AVEO Oncology (NASDAQ: AVEO) today announced the publication of
results from a monotherapy trial of tivozanib, the Company’s
vascular endothelial growth factor receptor tyrosine kinase
inhibitor (VEGFR-TKI), in patients with advanced, inoperable
hepatocellular carcinoma (HCC) in the British Journal of Cancer.
The article, titled “A multicentre phase 1b/2 study of tivozanib in
patients with advanced inoperable hepatocellular carcinoma,” is
available online first via this link.
For the Phase 1b/2 tivozanib study, a total of 27 patients were
enrolled. The study sought to evaluate the safety, dosing,
pharmacokinetics, pharmacodynamics, and preliminary anti-tumor
activity of tivozanib in patients with advanced HCC. The
recommended Phase 2 dose (RP2D) was determined to be 1.0 mg once
daily for 21 days followed by 7 days off treatment on a 28-day
cycle. Median progression free and overall survival were 24 weeks
and 9 months, respectively, for patients treated at the RP2D, with
an overall response rate of 21%. A significant decrease in soluble
plasma VEGFR-2 was also observed, suggesting adequate target
engagement.
“HCC represents the fastest rising cause of cancer-related death
in the U.S., with five-year survival at approximately 26%,” said
Michael Bailey, president and chief executive officer. “This study
is an important steppingstone in understanding tivozanib’s safety
and efficacy in HCC, and was the foundation for our ongoing Phase
1b/2 DEDUCTIVE study of tivozanib in combination with IMFINZI®
(durvalumab). As we work toward our expected filing of a New Drug
Application with the FDA this quarter for tivozanib in kidney
cancer, we look forward to expanding our tivozanib-immunotherapy
clinical strategy as part of our effort to maximize its long-term
potential.”
Enrollment is currently underway in a Phase 1b/2 DEDUCTIVE study
of tivozanib in combination with IMFINZI® (durvalumab),
AstraZeneca’s human monoclonal antibody directed against programmed
death-ligand 1 (PD-L1), in patients with HCC who have not received
prior systemic therapy. The trial is being conducted as part of a
clinical collaboration between AVEO and AstraZeneca.
“In a number of solid tumor indications, including metastatic
liver cancer, VEGF-TKI/immunotherapy combinations are playing an
increasingly important role in initial treatment selection,” said
Renuka Iyer, M.D., senior author of the publication and Professor
of Oncology and Co-Director, Liver and Pancreas Tumor Center,
Roswell Park Comprehensive Cancer Center. “Central to these
combinations is the tolerability of the VEGF-TKI backbone. With an
early efficacy signal and favorable tolerability profile
demonstrated in this study, tivozanib shows great potential as a
VEGF-TKI for such combinations. I look forward to seeing this
potential elucidated in the ongoing DEDUCTIVE study of tivozanib
and durvalumab in HCC.”
About Tivozanib
Tivozanib (FOTIVDA®) is an oral, once-daily, vascular
endothelial growth factor receptor (VEGFR) tyrosine kinase
inhibitor (TKI) discovered by Kyowa Kirin and approved for the
treatment of adult patients with advanced renal cell carcinoma
(RCC) in the European Union plus Norway, New Zealand 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 is being
studied in the TIVO-3 trial, which is intended to support a
regulatory submission of tivozanib in the U.S. as a treatment for
relapsed/refractory RCC. Tivozanib has been shown to significantly
reduce regulatory T-cell production in preclinical models3 and has
demonstrated synergy in combination with nivolumab (anti PD-1) in a
Phase 2 study in RCC4. Tivozanib has been investigated in several
tumor types, including renal cell, hepatocellular, colorectal,
ovarian and breast cancers.
About AVEO
AVEO is developing and seeks to commercialize its oncology
pipeline of products and product candidates in North America while
leveraging partnerships to support development and
commercialization in other geographies. 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, New Zealand and Iceland. Ficlatuzumab (HGF MAb) is
being studied in head and neck cancer and acute myeloid leukemia
clinical trials and has reported data in pancreatic cancer. AVEO’s
earlier-stage pipeline includes AV-203 (anti-ErbB3 MAb), AV-380
(GDF15 MAb) and AV-353 (Notch 3 MAb) drug candidates being
developed for various oncology indications. 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
within the meaning of the Private Securities Litigation Reform Act
of 1995 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 potential for tivozanib as a
treatment option for patients with advanced HCC or
relapsed/refractory or advanced RCC; the advancement of AVEO’s
pipeline, including AVEO’s plans with respect to the advancement of
the DEDUCTIVE trial; AVEO’s plans to submit an NDA for tivozanib;
AVEO’s plans to expand its tivozanib-immunotherapy clinical
strategy; the potential efficacy, safety, and tolerability of
tivozanib, both as a stand-alone drug candidate and in combination
with other therapies in several indications; AVEO’s execution of
its clinical and regulatory strategy for tivozanib; AVEO’s plans
and strategies for commercialization of tivozanib in the United
States and Europe; and AVEO’s strategy, prospects, plans and
objectives for its product candidates and for the Company
generally. 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, 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, in particular, tivozanib and ficlatuzumab; AVEO’s
ability to successfully file an NDA for tivozanib; and AVEO’s
ability to enter into and maintain its third party collaboration
and license agreements, and its ability, and the ability of its
strategic partners, to achieve development and commercialization
objectives under these arrangements. AVEO faces other risks
relating to its business as well, including risks relating to the
timing and costs of seeking and obtaining regulatory approval;
AVEO’s and its collaborators’ ability to successfully enroll and
complete clinical trials; AVEO’s ability to maintain compliance
with 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;
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 sections
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 makes with the SEC. The forward-looking
statements in this press release represent AVEO’s views as of the
date of this press release, and 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. Any reference to AVEO’s website address in this
press release is intended to be an inactive textual reference only
and not an active hyperlink.
References
1. Fotivda (Tivozanib) SmPC August 2017 2. Motzer RJ, Nosov D,
Eisen T, et al. J Clin Oncol 2013; 31(30): 3791-9. 3. Pawlowski N
et al. AACR 2013. Poster 3971. 4. Barthelemy et al. ESMO 2018.
Poster 878P
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version on businesswire.com: https://www.businesswire.com/news/home/20200212005900/en/
David Pitts, Argot Partners (212) 600-1902
aveo@argotpartners.com
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