AVEO Oncology Announces Submission of New Drug Application to U.S. FDA for Tivozanib in Patients with Relapsed or Refractory ...
March 31 2020 - 4:05PM
Business Wire
AVEO Oncology (NASDAQ: AVEO) today announced that it has
submitted a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for tivozanib, the Company’s vascular
endothelial growth factor receptor tyrosine kinase inhibitor
(VEGFR-TKI), as a treatment for relapsed or refractory renal cell
carcinoma (RCC).
“NDA submission is a distinguishing milestone for any
development stage biotechnology company, and our tivozanib NDA is
an important step in our goal of providing an effective and more
tolerable therapeutic option to patients with relapsed or
refractory RCC,” said Michael Bailey, president and chief executive
officer. “The TIVO-3 study provides valuable insight into the
potential sequencing of therapy following earlier TKI and
immunotherapy treatment, an area of significant need for kidney
cancer patients whose disease has relapsed or become refractory to
multiple lines of therapy. All of us at AVEO offer our continued
gratitude to the patients, caregivers, and investigators who
participated in our clinical trials. We look forward to working
closely with the FDA during their review process and remain hopeful
that the study’s overall survival (OS) hazard ratio (HR) will
continue to favor tivozanib at the time of the final readout,
expected by June 2020.”
The NDA submission is based on the pivotal active
comparator-controlled Phase 3 study, TIVO-3, comparing tivozanib to
sorafenib in 3rd and 4th line RCC patients. The application is
supported by three additional trials, including an active
comparator-controlled supportive Phase 3 study, TIVO-1, comparing
tivozanib to sorafenib, and two Phase 2 studies, Study 902, the
open-label, crossover clinical study of tivozanib for patients who
progressed on sorafenib in TIVO-1, as well as placebo-controlled
Study 201 in first line RCC patients.
A final OS analysis of the TIVO-3 study will be conducted in the
second quarter based on a May 1, 2020 data cutoff date. AVEO
expects to report results from the final OS analysis by June 2020.
The FDA and the Company agreed that if, during the review, the
final analysis yields an OS HR above 1.00, the Company will
withdraw its NDA.
About Tivozanib (FOTIVDA®)
Tivozanib (FOTIVDA®) is an oral, once-daily, 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.1,2
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/refractory RCC. 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 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 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; AVEO’s hope that the OS hazard ratio for
TIVO-3 will continue to favor tivozanib at the time of the final
readout; AVEO’s plan to conduct a final OS analysis in the second
quarter based on a May 1, 2020 data cutoff date and to report
results by June 2020; 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: the potential for
unfavorable final OS data from the TIVO-3 trial; the potential for
the FDA to not accept AVEO’s NDA for filing; 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; 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
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version on businesswire.com: https://www.businesswire.com/news/home/20200331005770/en/
David Pitts, Argot Partners (212) 600-1902
aveo@argotpartners.com
AVEO Pharmaceuticals (NASDAQ:AVEO)
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