CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 31, 2019--
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190131005509/en/
Source: AVEO Oncology
AVEO Contact:
David Pitts, Argot Partners
(212) 600-1902
aveo@argotpartners.com
