– Data Presented at the 2021 ASCO GI Cancers
Symposium –
AVEO Oncology (Nasdaq: AVEO) today announced the presentation of
results from the Phase 1b portion of the Phase 1b/2 DEDUCTIVE
clinical trial of tivozanib (FOTIVDA®), AVEO’s vascular endothelial
growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) drug
candidate, in combination with IMFINZI® (durvalumab), AstraZeneca’s
(LSE/STO/Nasdaq: AZN) human monoclonal antibody directed against
programmed death-ligand 1 (PD-L1), in patients with advanced or
metastatic hepatocellular carcinoma (HCC). The results are being
presented today in a poster session at the 2021 American Society of
Clinical Oncology Gastrointestinal (ASCO GI) Cancers Symposium
being held virtually.
A total of seven patients with advanced or metastatic HCC were
enrolled in the Phase 1b portion of the study, which was designed
to determine the recommended Phase 2 dose and assess preliminary
safety and efficacy of the tivozanib/durvalumab combination.
Patients received 1.0 mg of tivozanib for 21 days followed by 7
days off therapy combined with 1500 mg of durvalumab every 28 days.
The combination was well tolerated, with no dose-limiting
toxicities. The combination demonstrated a 29% partial response
(PR) rate and 71% disease control rate (PR + stable disease).
Completion of enrollment in the ongoing Phase 2 portion of the
study, which is expected to enroll up to an additional 30 subjects,
is anticipated later this year.
“With a five-year survival rate of less than 5%, advanced or
metastatic HCC represents an area of high unmet need,” said Renuka
Iyer, M.D., Professor of Oncology and Co-Director, Liver and
Pancreas Tumor Center, Roswell Park Comprehensive Cancer Center.
“These data demonstrated the tolerability of the tivozanib and
immunotherapy combination, and I look forward to its further
evaluation in the Phase 2 portion of the study.”
“We believe that data observed in the Phase 1b portion of the
DEDUCTIVE study continue to support tivozanib’s potential to serve
as an attractive VEGFR TKI to use in the immunotherapy combination
setting,” said Michael Bailey, president and chief executive
officer of AVEO. “As we await a decision on our New Drug
Application for single agent tivozanib in relapsed or refractory
renal cell carcinoma (RCC), we remain focused on executing on our
combination strategy, including in metastatic RCC and HCC.”
About Tivozanib (FOTIVDA®)
Tivozanib is an oral, once-daily, next-generation VEGFR TKI
discovered by Kyowa Kirin Co. and approved as FOTIVDA® for the
treatment of adult patients with advanced RCC in the European Union
and other countries in the territory of the Company’s partner, EUSA
Pharma (UK) Limited (EUSA territory). 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 adult
patients with relapsed or refractory advanced 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 RCC.4 Tivozanib
has been investigated in several tumor types, including renal cell,
hepatocellular, colorectal, ovarian and breast cancers. Tivozanib
is also being studied by partner Kyowa Kirin Co. in non-oncology
indications.
About AVEO Pharmaceuticals, Inc.
AVEO is an oncology-focused biopharmaceutical company committed
to delivering medicines that provide a better life for cancer
patients. 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, is approved as FOTIVDA® in the European Union and other
countries in the EUSA territory for the treatment of adult patients
with advanced RCC. 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 or
refractory RCC. AVEO has previously reported promising early
clinical data on ficlatuzumab (anti-HGF mAb) in head and neck
cancer, acute myeloid leukemia and pancreatic cancer and is
conducting a randomized Phase 2 confirmatory clinical trial of
ficlatuzumab in head and neck cancer. AVEO’s earlier-stage pipeline
includes several monoclonal antibodies in oncology development,
including AV-203 (anti-ErbB3 mAb), AV-380 (anti-GDF15 mAb) and
AV-353 (anti-Notch 3 mAb). AVEO is committed to creating an
environment of diversity and inclusion as a foundation for
innovation.
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,” “design,” “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; 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 current and
future clinical trials of tivozanib, ficlatuzumab and AV-380 and
for commercialization of tivozanib in the United States; the
advancement of AVEO’s pipeline, including the advancement of
ficlatuzumab in multiple clinical studies; the potential efficacy,
safety and tolerability of ficlatuzumab, both as a stand-alone drug
candidate and in combination with other therapies; the potential
outcomes from studies of ficlatuzumab to provide AVEO with
opportunities to pursue regulatory strategies; the potential
clinical utility of ficlatuzumab in areas of unmet need; 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: 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 progression-free survival, the
rate of adverse events, overall survival and other information that
the FDA may consider to be relevant to an approval determination;
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
and to obtain and maintain market and third party payor acceptance
of 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 launch and commercialization of tivozanib; 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
risks relating to the timing and costs of seeking and obtaining
regulatory approvals; 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’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; unplanned capital requirements; uncertainties related
to AVEO’s ability to access future borrowings under the Hercules
loan facility, which turns on the achievement of milestones related
to the approval and commercialization of tivozanib in the U.S.,
which milestones may not be achieved; adverse general economic and
industry conditions; the potential adverse effects of the COVID-19
pandemic on AVEO’s business continuity, financial condition,
results of operations, liquidity and ability to successfully and
timely enroll, complete and read-out data from its clinical trials;
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/20210115005128/en/
AVEO: David Pitts, Argot Partners (212) 600-1902
aveo@argotpartners.com
AVEO Pharmaceuticals (NASDAQ:AVEO)
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