AVEO Oncology (NASDAQ:AVEO) today announced the presentation of
data from the Phase 3 TIVO-3 study of tivozanib (FOTIVDA®) versus
sorafenib in refractory advanced or metastatic renal cell carcinoma
(RCC). The data were presented by Brian Rini, MD, Professor of
Medicine, Cleveland Clinic Lerner College of Medicine of Case
Western Reserve University, and Director, Cleveland Clinic
Genitourinary Cancer Program, during an oral presentation titled,
“TIVO-3: A Phase 3, Randomized, Controlled, Multi-Center,
Open-Label Study to Compare Tivozanib to Sorafenib in Subjects with
Refractory Advanced Renal Cell Carcinoma (RCC)” at the 2019
American Society of Clinical Oncology (ASCO) Genitourinary (GU)
Cancers Symposium held February 14-16, 2019 in San Francisco. A
copy of the presentation will be available in the Publications
& Presentation section of the Company’s website.
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the full release here:
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Figure 1: Progression-Free Survival per
Independent Review Committee (IRC) in the Intent to Treat
Population (Graphic: Business Wire)
“Tivozanib continues to demonstrate a unique activity and
tolerability profile among VEGF TKIs in the treatment of kidney
cancer,” said Dr. Rini. “This is underscored by a significant
improvement in progression free survival and overall response rate
compared to sorafenib in patients with treatment-refractory
advanced RCC. I look forward to understanding how this improvement
impacts overall survival as the TIVO-3 study continues to
mature.”
“We remain committed to our goal of improving outcomes and
patient experience in RCC,” said Michael Bailey, president and
chief executive officer of AVEO. “The improvement in progression
free survival in the TIVO-3 study, particularly in patients who
received prior immunotherapy, is noteworthy. We are hopeful that
these positive PFS outcomes translate into an improved overall
survival hazard ratio when we report a more mature interim OS
outcome in the fourth quarter of 2019. We expect to make a new drug
application filing decision following the availability of more
mature OS results.”
TIVO-3 Topline Study Results
The TIVO-3 trial is a Phase 3 randomized, controlled,
multi-center, open-label study designed to compare tivozanib
(FOTIVDA®) to sorafenib in 350 subjects with highly refractory
advanced or metastatic renal cell carcinoma (RCC). The trial met
its primary endpoint of demonstrating a statistically significant
benefit in progression-free survival (PFS). Tivozanib demonstrated
a 44% improvement in median PFS and 26% reduction in the risk of
progression or death (Hazard Ratio [HR]=0.74, p=0.02, see Figure
1). Median PFS was 5.6 months for tivozanib compared to 3.9 months
for sorafenib.
The TIVO-3 trial enrolled patients with RCC who have failed at
least two prior regimens. Among these, approximately 26% of
patients received checkpoint inhibitor (CPI) therapy in earlier
lines of treatment. PFS for tivozanib was longer than sorafenib
both in patients who received prior CPI therapy and those who
received two prior VEGF TKI therapies. Patients who received prior
CPI therapy had a median PFS of 7.3 months with tivozanib and 5.1
months with sorafenib (HR=0.55, p=0.03, see Figure 2). One- and
two-year PFS in patients who received tivozanib following CPI
therapy was 35% and 25%, respectively, and 4% and n/a for patients
receiving sorafenib following CPI therapy at those respective time
periods.
The secondary endpoint of overall response rate for patients
receiving tivozanib was 18% compared to 8% for patients receiving
sorafenib (p=0.02). Median duration of response (DOR) in patients
receiving tivozanib was not reached (95% CI:12.9,---) and was 5.7
months for patients receiving sorafenib (95% CI:5.6,---). DOR
probability at 1 year was 71% and 46% for tivozanib and sorafenib,
respectively, and 55% and 0% at two years.
The analysis of the secondary endpoint of overall survival (OS)
was not mature at the time of the final PFS analysis, and currently
reflects ~50% of potential OS events. As previously disclosed, the
updated preliminary OS analysis conducted at an October 4, 2018
data cutoff date, which included additional patients previously
lost to follow-up, showed a non-statistically significant
difference in OS favoring sorafenib (HR=1.12, p=0.44). The Company
intends to conduct an additional interim OS analysis in August
2019, the results of which are expected to be reported in the
fourth quarter of 2019.
Tivozanib was 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.
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
(RCC) 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.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 RCC. Tivozanib has been
investigated in several tumor types, including renal cell,
hepatocellular, colorectal and breast cancers.
About AVEO
AVEO Pharmaceuticals, Inc. (the “Company” or “AVEO”) is a
biopharmaceutical company dedicated to advancing a broad portfolio
of targeted medicines for oncology and other areas of unmet medical
need. The Company’s strategy is to retain North American rights to
its oncology portfolio while securing partners in development and
commercialization outside of North America. The Company is seeking
to develop and commercialize its lead candidate tivozanib in North
America as a treatment for advanced or metastatic renal cell
carcinoma (“RCC”). The Company has outlicensed tivozanib (FOTIVDA®)
for oncological indications in Europe and other territories outside
of North America. Tivozanib is approved in the European Union, as
well as Norway and Iceland, for the first-line treatment of adult
patients with RCC and for adult patients who are vascular
endothelial growth factor receptor and mTOR pathway inhibitor-naïve
following disease progression after one prior treatment with
cytokine therapy for RCC. In addition, a new formulation of
tivozanib is being explored in ocular conditions. The Company has
entered into partnerships for the development and commercialization
of AV-203 (CAN017) and ficlatuzumab, both clinical stage assets in
oncology. The Company is currently seeking a partner to develop the
AV-353 platform, a preclinical asset, worldwide for the potential
treatment of pulmonary arterial hypertension and oncology. The
Company has recently regained the rights to its AV-380 program for
the potential treatment of cachexia and is initiating toxicology
studies to support the filing of an initial new drug application
and advance the program’s development.
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: AVEO’s plans to make a NDA filing
decision following the availability of more mature OS results;
AVEO’s plans to complete an interim OS analysis for the TIVO-3
trial in August 2019 and to report the results of this analysis in
the fourth quarter; AVEO’s plans to present TIVO-3 data at ASCO GU;
AVEO’s expectation that the OS outcome will be more mature by
August 2019; AVEO’s hope that the positive PFS outcome will
translate into an improved hazard ratio; AVEO’s intent to continue
to work with the FDA to determine tivozanib’s risk-benefit profile
as a single agent in RCC; the efficacy, safety, and tolerability of
tivozanib, as a single agent and in combination with other
therapies in several indications, such as RCC and HCC; AVEO’s plans
and strategies for commercialization of tivozanib in the United
States and Europe; AVEO’s plans to develop the AV-353 platform;
AVEO’s plans regarding AV-380 and AVEO’s other 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
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20190216005008/en/
AVEO:David Pitts, Argot Partners(212)
600-1902aveo@argotpartners.com
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