- Final OS Hazard Ratio Improves to 0.97 -
- Company to Host Conference Call Today at 8:30
am Eastern Time -
AVEO Oncology (NASDAQ: AVEO) today announced the presentation of
results from the final analysis of overall survival (OS) in its
pivotal Phase 3 TIVO-3 trial comparing tivozanib, the Company’s
next-generation vascular endothelial growth factor (VEGF) receptor
tyrosine kinase inhibitor (TKI), to sorafenib in 3rd and 4th line
renal cell carcinoma (RCC). The results, which have been submitted
to the U.S. Food and Drug Administration (FDA) as part of the
Company’s New Drug Application (NDA) submitted in March, are being
featured today at the ASCO 2020 Virtual Scientific Program in a
poster titled, “TIVO-3: Final OS analysis of a phase III,
randomized, controlled, multicenter, open-label study to compare
tivozanib to sorafenib in subjects with metastatic renal cell
carcinoma (RCC)” (abstract 5062). A copy of the poster will be
available at the ASCO virtual meeting beginning today, May 29,
2020, at 8:00 AM ET. The poster and accompanying oral presentation
by Sumanta (Monty) Pal, MD, Associate Clinical Professor,
Department of Medical Oncology and Therapeutics Research, and
Co-director, Kidney Cancer Program, at City of Hope Comprehensive
Cancer Center, can be viewed at www.aveooncology.com.
As previously announced, the TIVO-3 trial met the primary
endpoint of progression free survival (PFS) (HR=0.73; p=0.02) and
the secondary endpoint of overall response rate (ORR) (18% vs. 8%;
p=0.02). The final OS hazard ratio (HR), which assesses the overall
relative risk of death, was 0.97 (95% CI: 0.75-1.25; p=0.82),
favoring tivozanib and improving from the previously reported
interim HR of 0.99. Updated median OS, representing a single point
in time in the OS curve, was 16.4 months for tivozanib (95% CI:
13.4-22.2) and 19.2 months for sorafenib (95% CI: 15.0-24.2). These
OS HR results are similar to those of prior VEGFR TKI vs. VEGFR TKI
studies in RCC.1-4
Tivozanib was found to be generally well-tolerated, with grade 3
or higher adverse events (AEs) consistent with those observed in
previous tivozanib trials. The most common AE in patients receiving
tivozanib was hypertension (38% vs. 25% for sorafenib, of treated
patients), an AE known to reflect effective VEGF pathway
inhibition. Infrequent but severe AEs reported in greater number in
the tivozanib arm were thrombotic events (5% vs. 4% for sorafenib,
of treated patients) similar to those observed in previous
tivozanib studies. Dose reductions and interruptions due to AEs
were significantly lower for tivozanib vs. sorafenib, despite
nearly double the average number of cycles initiated for the
tivozanib arm (11.9 months vs. 6.7 months for sorafenib), treatment
related AEs leading to permanent discontinuation were 8% for
tivozanib vs. 15% for sorafenib.
“We believe the TIVO-3 data demonstrate a favorable risk/benefit
profile for tivozanib in the growing population of patients who
have relapsed or become refractory to multiple lines of therapy,
including checkpoint inhibitors,” said Dr. Pal. “The lack of
clinical data to guide treatment decisions in a robust,
evidence-based manner in this setting is a serious and growing
unmet medical need, particularly as this population continues to
grow thanks to improved treatment in earlier lines. TIVO-3 provides
the first positive superiority study to help guide this important
treatment decision and, furthermore, offers this highly refractory
patient population a favorable tolerability profile as indicated by
fewer dose reductions, interruptions and discontinuations over a
less selective VEGFR TKI in sorafenib.”
“This outcome marks a significant milestone in a long journey to
see tivozanib fulfill its potential, and is a critical step forward
in our goal to improve both efficacy outcomes and patient
experience for individuals living with cancer,” said Michael
Bailey, president and chief executive officer of AVEO. “Tivozanib
has the potential to define highly refractory kidney cancer
treatment, an area with no current evidence-based standard of care.
We look forward to continuing our dialogue with the FDA as we work
toward a marketing authorization decision, and we will continue to
build on our foundation for commercial readiness. We owe our
deepest gratitude to the patients and their families for
participating in the tivozanib clinical program, and to the
healthcare professionals who have continued to believe in the
potential of tivozanib.”
Conference Call and Webcast
In connection with this announcement, AVEO will host a
conference call and audio webcast today, May 29, 2020, at 8:30 am
Eastern Time. Dr. Pal will join the AVEO management team to review
the data announced today. The call can be accessed by dialing (844)
882-7841 (U.S. and Canada) or (574) 990-9828 (international). The
passcode for the conference call is 7967605. To access the live
audio webcast, or the subsequent archived recording, please visit
the Investors section of the AVEO website at www.aveooncology.com.
The webcast will be recorded and available for replay on AVEO’s
website for two weeks.
About Tivozanib (FOTIVDA®)
Tivozanib (FOTIVDA®) is an oral, once-daily, next-generation
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, the United Kingdom, 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.5,6
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. Tivozanib
has been shown to significantly reduce regulatory T-cell production
in preclinical models7 and has demonstrated synergy in combination
with nivolumab (anti PD-1) in a Phase 2 study in RCC8. Tivozanib
has been investigated in several tumor types, including renal cell,
hepatocellular, colorectal, ovarian and breast cancers.
About AVEO
AVEO is developing an oncology pipeline designed to provide a
better life for patients with cancer. 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 (FOTIVDA®), is approved in the
European Union, the United Kingdom, Norway, New Zealand and Iceland
for the treatment of adult patients with advanced renal cell
carcinoma. AVEO is working to develop and commercialize tivozanib
in North America as a treatment for renal cell carcinoma,
hepatocellular carcinoma and other cancers. Ficlatuzumab (HGF MAb)
is in a Phase 2 clinical trial in head and neck cancer and has
reported early clinical data in pancreatic cancer. AVEO’s
earlier-stage pipeline includes several monoclonal antibodies in
oncology development, including AV-203 (anti-ErbB3 MAb), AV-380
(GDF15 MAb) and AV-353 (Notch 3 MAb). 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,” “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, and following earlier TKI and
immunotherapy treatment;; 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:; 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 PFS, the rate of adverse events, OS and other
information that the FDA may determine to be relevant to
approvability; 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 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, including its
ability to successfully launch and commercialize 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 development and
commercialization of tivozanib; unplanned capital requirements;
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
- Hutson et al. Clinical Genitourinary Cancer; Vol. 15, No. 1,
72-6.
- Choueiri et al. European Journal of Cancer 2018; 94:
115e125
- Motzer et. al. Lancet Oncol 2013; 14: 552–62.
- Motzer, et al. N Engl J Med. 2014;370(18):1769-1770.
- 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/20200529005120/en/
AVEO Contact: David Pitts, Argot Partners (212) 600-1902
aveo@argotpartners.com
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