– Data Presented at the ASCO 2021 GU Cancers
Symposium –
–Sequencing Data Support Tivozanib is a
Differentiated Selective VEGF TKI; Q-TWiST Quality of Life Measure
Shows Significant Improvement for Tivozanib over Sorafenib –
AVEO Oncology (Nasdaq: AVEO) today announced the presentation of
two analyses of the Company’s pivotal TIVO-3 study, its Phase 3
trial comparing tivozanib, AVEO’s next-generation vascular
endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor
(TKI) drug candidate, to sorafenib in third- and fourth-line renal
cell carcinoma (RCC). The data are being presented in a poster
discussion session at the American Society of Clinical Oncology
(ASCO) 2021 Genitourinary (GU) Cancers Symposium being held
virtually.
“Data reported today continue to support tivozanib’s
differentiation among TKIs and its potential to serve as a
meaningful option for RCC patients who have relapsed or become
refractory to multiple lines of therapy,” said Brian Rini, MD,
Chief of Clinical Trials at Vanderbilt Ingram Cancer Center. “Of
note, sequencing data suggest differential activity between
tivozanib and axitinib, despite both being potent and selective
VEGF TKIs. With no existing evidence-based standard of care for
this historically difficult-to-treat population, tivozanib could
potentially play a key role in the evolving relapsed or refractory
RCC treatment landscape.”
“These findings enhance our understanding of tivozanib in a
clinically relevant patient population and add to the body of data
from TIVO-3, which, as the first positive superiority study in
patients who have relapsed or become refractory to two or more
systemic therapies, could potentially serve as an important guide
for treatment decisions in this setting,” said Michael Bailey,
president and chief executive officer of AVEO. “As we await the
U.S. Food and Drug Administration’s decision on our New Drug
Application submission for tivozanib as a treatment for relapsed or
refractory RCC, we remain focused on commercial preparations to
support a robust potential U.S. launch. We are committed to our
mission of improving both outcomes and patient experience, and to
ensuring that tivozanib becomes available to as many appropriate
patients as possible.”
ASCO GU Data
- Q-TWiST Analysis. A poster titled, “Q-TWiST analysis of
tivozanib versus sorafenib in patients with advanced renal cell
carcinoma (RCC) in the TIVO-3 study” (abstract 298) highlighted
findings from a quality-adjusted time without symptoms or toxicity
analysis (Q-TWiST) used to assess health-related quality of life.
Findings showed that tivozanib significantly increased Q-TWiST
relative to sorafenib in patients treated in the TIVO-3 study
(15.04 months vs. 12.78 months; p=0.0493), and tivozanib nearly
doubled Q-TWiST compared to sorafenib (10.30 months vs. 5.35
months.) These data suggest that tivozanib may convey tolerability
advantages as measured by a patient-centered health-related patient
quality of life. Q-TWiST analyses have previously been used to
assess other TKIs for the treatment of RCC.
- Prior Axitinib Therapy. A presentation titled,
“Tivozanib in Patients with Advanced Renal Cell Carcinoma (aRCC)
who have Progressed After Prior Treatment with Axitinib: Results
from TIVO-3” (abstract 278) highlighted outcomes of TIVO-3 patients
who received prior axitinib therapy, now commonly part of
front-line advanced RCC treatment. Of this group, patients treated
with tivozanib (n=83) demonstrated a median progression free
survival (PFS) of 5.5 months compared to 3.7 months for those
treated with sorafenib (n=89) (Hazard Ratio of 0.68), with an
overall response rate of 13% and 8%, respectively. In addition,
prior axitinib therapy did not appear to influence tivozanib
tolerability, with adverse events, including dose reductions,
interruptions, and discontinuations, similar in patients treated
with and without prior axitinib therapy. These results suggest that
tivozanib, a selective VEGF TKI, is active following prior axitinib
therapy and can potentially provide superior PFS benefit compared
to sorafenib, a multi-targeted VEGF TKI.
A copy of each presentation will be available in the Scientific
Publications & Presentations section of AVEO’s website.
About Tivozanib (FOTIVDA®)
Tivozanib is an oral, once-daily, next-generation VEGF TKI
discovered by Kyowa Kirin Co. and approved as FOTIVDA® for the
treatment of adult patients with advanced RCC in the European Union
and other countries in the territory of the Company’s partner, EUSA
Pharma (UK) Limited (EUSA territory). 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 supporting a regulatory submission of tivozanib in
the U.S. seeking marketing approval as a treatment for adult
patients with relapsed or refractory advanced 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 RCC.4 Tivozanib
has been investigated in several tumor types, including renal cell,
hepatocellular, colorectal, ovarian and breast cancers. Tivozanib
is also being studied by partner Kyowa Kirin Co. in non-oncology
indications.
About AVEO Pharmaceuticals, Inc.
AVEO is an oncology-focused biopharmaceutical company committed
to delivering medicines that provide a better life for cancer
patients. AVEO’s strategy is to focus its resources toward
development and commercialization of its product candidates in
North America, while leveraging partnerships to support development
and commercialization in other geographies. AVEO’s lead candidate,
tivozanib, is approved as FOTIVDA® in the European Union and other
countries in the EUSA territory for the treatment of adult patients
with advanced RCC. Tivozanib is being studied in the TIVO-3 trial,
which is supporting a regulatory submission of tivozanib in the
U.S. seeking marketing approval as a treatment for relapsed or
refractory RCC. AVEO has previously reported promising early
clinical data on ficlatuzumab (anti-HGF mAb) in head and neck
cancer, acute myeloid leukemia and pancreatic cancer and is
conducting a randomized Phase 2 confirmatory clinical trial of
ficlatuzumab in head and neck cancer. AVEO’s earlier-stage pipeline
includes several monoclonal antibodies in oncology development,
including AV-203 (anti-ErbB3 mAb), AV-380 (anti-GDF15 mAb) and
AV-353 (anti-Notch 3 mAb). AVEO is committed to creating an
environment of diversity and inclusion as a foundation for
innovation.
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,” “design,” “expect,” “hope,” “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 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 current and
future clinical trials of tivozanib and for commercialization of
tivozanib in the United States; the advancement of AVEO’s pipeline,
including the advancement of ficlatuzumab in multiple clinical
studies; 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: whether the results of TIVO-3 are sufficient to obtain
marketing approval for tivozanib in the U.S., which turns on the
ability of AVEO to demonstrate to the satisfaction of the FDA the
safety and efficacy of tivozanib based upon the findings of TIVO-3,
including its data with respect to progression-free survival, the
rate of adverse events, overall survival and other information that
the FDA may consider to be relevant to an approval determination;
AVEO’s ability to successfully implement its strategic plans,
including its ability to successfully launch and commercialize
tivozanib if it may be approved for commercialization by the FDA
and to obtain and maintain market and third party payor acceptance
of tivozanib if it may be approved for commercialization by the
FDA; AVEO’s ability to raise the substantial additional funds
required to achieve its goals, including those goals pertaining to
the launch and commercialization of tivozanib; 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, and
risks relating to the timing and costs of seeking and obtaining
regulatory approvals; 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’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; unplanned capital requirements; uncertainties related
to AVEO’s ability to access future borrowings under the Hercules
loan facility, which turns on the achievement of milestones related
to the approval and commercialization of tivozanib in the U.S.,
which milestones may not be achieved; adverse general economic and
industry conditions; the potential adverse effects of the COVID-19
pandemic on AVEO’s business continuity, financial condition,
results of operations, liquidity and ability to successfully and
timely enroll, complete and read-out data from its clinical trials;
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
- Fotivda (Tivozanib) SmPC August 2017
- Motzer RJ, Nosov D, Eisen T, et al. J Clin Oncol 2013; 31(30):
3791-9
- Pawlowski N et al. AACR 2013. Poster 3971
- Barthelemy et al. ESMO 2018. Poster 878P
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210211005220/en/
AVEO Contact: David Pitts, Argot Partners (212) 600-1902
aveo@argotpartners.com
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