AVEO Oncology (NASDAQ: AVEO) today announced that it has
accepted the recommendation of the U.S. Food and Drug
Administration (FDA) not to submit a New Drug Application (NDA) for
tivozanib (FOTIVDA®) with the preliminary overall survival (OS)
results from the Phase 3 TIVO-3 trial. The FDA indicated that these
preliminary OS results do not allay their concerns about the
potential detriment in OS outlined in the complete response letter
dated June 6, 2013. The Company now plans to make a NDA filing
decision following the availability of more mature OS results.
As disclosed in November 2018, a preliminary analysis of the
secondary endpoint of OS in the TIVO-3 trial showed a hazard ratio
(HR) > 1. The Company previously planned to conduct the final OS
analysis in August 2019. Due to the longer-than-expected median OS
in both arms, and following discussions with the FDA, the Company
plans to designate the August 2019 OS analysis as interim. Results
of this analysis are expected to be reported in the fourth
quarter.
Since initially conducting the preliminary analysis of the OS
endpoint in November 2018, the Company has identified the survival
status of a group of patients that were previously lost to follow
up. With the identification of these OS events, the October 4, 2018
preliminary OS HR was revised from 1.06 to 1.12. The Company has
not performed any OS analyses beyond the preliminary October 4,
2018 data cut-off date.
AVEO intends to present detailed results of the TIVO-3 study,
the Company’s Phase 3 randomized, controlled, multi-center,
open-label study comparing tivozanib to sorafenib in 350 subjects
with highly refractory advanced or metastatic Renal Cell Carcinoma
(RCC) during an oral session at the 2019 American Society of
Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) being
held February 14-16, 2019 in San Francisco.
“We are hopeful that the positive PFS outcome will translate
into an improved hazard ratio when we evaluate a more mature
interim OS outcome in the fourth quarter of 2019,” said Michael
Bailey, president and chief executive officer of AVEO. “We look
forward to continuing to work with the FDA to determine tivozanib’s
benefit-risk profile as a single agent in RCC patients.”
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 tumors 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. 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. In addition, a new
formulation of tivozanib is being explored in ocular conditions.
The Company has recently regained the rights to its AV-380 program
for the potential treatment of cachexia and is considering a
variety of options to 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 plan to seek a partner 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 as it relates to
the TIVO-3 trial and tivozanib; AVEO’s ability to successfully file
an NDA for tivozanib on the timeline it anticipates, or at all; 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/20190131005509/en/
AVEO Contact:David Pitts, Argot Partners(212)
600-1902aveo@argotpartners.com
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