- 20 Patients Remain Progression Free on
Tivozanib Arm vs. 2 on Sorafenib Arm -
- Company Plans to Discuss Updated Results with
FDA -
- AVEO to Host Conference Call Today at 8:00 am
Eastern Time -
AVEO Oncology (NASDAQ: AVEO) today announced results from the
second prespecified analysis of overall survival (OS) in the TIVO-3
trial. TIVO-3 is the Company’s Phase 3 randomized, controlled,
multi-center, open-label study to compare tivozanib (FOTIVDA®) to
sorafenib in 350 subjects with highly refractory metastatic renal
cell carcinoma (RCC). These results include an OS hazard ratio (HR)
below 1.00, favoring tivozanib (HR=0.99; 95% CI: 0.76-1.29;
p=0.95). An OS hazard ratio assesses the relative risk of death for
the entirety of the data set. TIVO-3 is the first and only positive
Phase 3 study in 3rd and 4th line RCC, and the first Phase 3 study
in RCC to investigate a predefined subpopulation of patients who
received prior immunotherapy, an emerging standard of care for
earlier lines of therapy.
The data cutoff date for the second prespecified analysis was
August 15, 2019, two years from the last patient enrolled and
approximately ten months from the data cut-off date for the first
prespecified analysis. Between the two data cut-off dates, 16
additional OS events were reported on the tivozanib arm and 28 on
the sorafenib arm, resulting in a total of 114 OS events on the
tivozanib arm and 113 on the sorafenib arm. Median OS, a point in
time value separating the earlier half of events from the latter
half within each arm, was 16.4 months for tivozanib (95% CI:
13.4-22.2) and 19.7 months for sorafenib (95% CI: 15.0-24.2).
Twenty patients remain progression free on the tivozanib arm and
two on the sorafenib arm, with a median duration on study of 32.5
months.
In November 2018, the Company announced positive final results
for the primary endpoint of progression-free survival (PFS) and the
secondary endpoint of overall response rate (ORR). Statistically
significant improvements favoring tivozanib were reported for PFS
(HR=0.73; p=0.0165) and ORR (18% vs. 8%; p=0.02). The Company also
announced that tivozanib was found to be generally well-tolerated,
with grade 3 or higher adverse events consistent with those
observed in previous tivozanib trials. Infrequent but severe
adverse events reported in greater number in the tivozanib arm were
thrombotic events similar to those observed in previous tivozanib
studies. The most common adverse event in patients receiving
tivozanib was hypertension, an adverse event known to reflect
effective VEGF pathway inhibition.
The Company plans to discuss the updated OS results with the
U.S. Food and Drug Administration to identify the appropriate path
forward for tivozanib in RCC in the fourth quarter, and to provide
an update regarding the potential submission of a New Drug
Application for tivozanib in RCC following these discussions.
“These are the first data to demonstrate durable improvements in
this highly refractory advanced kidney cancer population, including
the post-immunotherapy setting, a predefined subset of the TIVO-3
trial,” said Brian Rini, MD, Professor of Medicine, Cleveland
Clinic Lerner College of Medicine of Case Western Reserve
University, Director, Cleveland Clinic Genitourinary Cancer
Program, and principal investigator of the TIVO-3 trial. “The
TIVO-3 study suggests the potential for tivozanib to serve as an
important new treatment option for patients with advanced RCC. I
look forward to seeing tivozanib studied further in the
immunotherapy combination setting, and to continuing to explore its
full potential in the evolving RCC treatment landscape.”
“We are pleased to see that the positive PFS and ORR outcomes
from TIVO-3 have translated into an improved OS hazard ratio,” said
Michael Bailey, president and chief executive officer of AVEO. “On
behalf of the entire AVEO team, we once again offer our sincerest
thanks to the patients, caregivers and investigators for
participating in this study. AVEO remains committed to improving
outcomes for patients with RCC, and we look forward to discussing
these results with the FDA.”
Conference Call and Webcast
In connection with this announcement, AVEO will host a
conference call and audio webcast today, September 10, 2019, at
8:00 am Eastern Time. 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 3275406. 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 TIVO-3
The TIVO-3 trial was designed to enroll patients with RCC who
have failed at least two prior regimens, including VEGFR-TKI
therapy. Eligible patients may also have received checkpoint
inhibitor therapy in earlier lines of treatment. Patients were
randomized 1:1 to receive either tivozanib or sorafenib, with no
crossover between arms. The primary endpoint of the study is
progression free survival (PFS). Secondary endpoints include
overall survival (OS), overall response rate (ORR), and safety and
tolerability. TIVO-3, together with the previously completed TIVO-1
trial of tivozanib in the first line treatment of RCC, is designed
to support a regulatory submission of tivozanib in the U.S. as a
treatment for RCC in multiple lines of therapy. TIVO-3 patients
were exclusively enrolled in North America, Western Europe, and
Central Europe.
About Tivozanib (FOTIVDA®)
Tivozanib (FOTIVDA®) is an oral, once-daily, vascular
endothelial growth factor (VEGF) 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 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 Pharmaceuticals is a biopharmaceutical company seeking to
advance targeted medicines for oncology and other unmet medical
needs. The Company’s lead candidate is tivozanib, a potent,
selective, long half-life inhibitor of vascular endothelial growth
factor 1, 2 and 3 receptors, which AVEO is working to develop and
commercialize in North America as a treatment for renal cell
carcinoma (RCC), hepatocellular carcinoma (HCC) and other cancers.
Tivozanib (FOTIVDA®) is approved by the European Commission for the
treatment of adult patients with advanced RCC in the European Union
plus Norway, New Zealand and Iceland. AVEO is leveraging or seeks
to leverage partnerships to develop and commercialize its pipeline
of products and product candidates, including tivozanib in oncology
and other indications in various geographies, and ficlatuzumab (HGF
MAb) in head and neck cancer, pancreatic cancer and acute myeloid
leukemia. 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 RCC; AVEO’s plans to
discuss the updated OS results from TIVO-3 with the FDA to identify
the path forward for tivozanib in RCC and to provide an update
regarding a potential NDA submission; the potential efficacy,
safety, and tolerability of tivozanib, as a single agent and in
combination with other therapies in several indications, such as
RCC and HCC; 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; 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
- 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/20190910005358/en/
AVEO: David Pitts, Argot Partners (212) 600-1902
aveo@argotpartners.com
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