AVEO Oncology (NASDAQ: AVEO) today announced that it has
initiated enrollment in an open-label, multi-center Phase 1b/2
clinical trial evaluating FOTIVDA® (tivozanib), the Company’s
once-daily, potent and selective vascular endothelial growth factor
receptor tyrosine kinase inhibitor (VEGFR-TKI), in combination with
IMFINZI® (durvalumab), AstraZeneca’s human monoclonal antibody
directed against programmed death-ligand 1 (PD-L1), in patients
with hepatocellular carcinoma (HCC) who have not received prior
systemic therapy.
The study is expected to enroll approximately 50 patients. The
Phase 1b portion will evaluate the safety, tolerability, dose
limiting toxicity, maximum tolerated dose and preliminary
anti-tumor activity starting with 1.0mg of tivozanib for 21 days
followed by 7 days rest together with 1500mg of durvalumab every 28
days. Assuming satisfactory completion of the Phase 1b portion of
the study, a Phase 2 expansion cohort will enroll at the dose
schedule designated in Phase 1b. The primary outcome measure is
incidence of treatment emergent adverse events. Secondary outcome
measures include objective response rate per RECIST 1.1,
progression free survival, duration of response, and overall
survival. The trial is being conducted as part of a clinical
collaboration between AVEO and AstraZeneca. AVEO is serving as the
study sponsor, with study costs shared equally by both parties and
clinical drug supplied by each respective company.
“HCC is the fastest rising cause of cancer-related death in the
U.S., driven by prevalent diseases that include hepatitis B and C,
nonalcoholic steatohepatitis and obesity. With five-year survival
at approximately 26%, there remains a desperate need for new
therapeutic options,” said Michael Bailey, president and chief
executive officer of AVEO. “VEGF TKIs and immunotherapy represent
current standard of care monotherapies for advanced HCC, and we
believe that the combination of tivozanib and durvalumab, both of
which have demonstrated single agent activity in HCC, holds great
promise as a potential new treatment option for this patient
population. Tivozanib’s unique tolerability profile has the
potential to make it an attractive VEGF TKI to combine with
immunotherapy; in collaboration with AstraZeneca, we look forward
to elucidating the potential of the tivozanib-durvalumab
combination in patients with previously untreated advanced liver
cancer.”
About Tivozanib
Tivozanib (FOTIVDA®) is an oral, once-daily, vascular
endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI)
approved for the treatment of adult patients with advanced renal
cell carcinoma (RCC) in the European Union plus Norway, New Zealand
and Iceland. It is a potent and selective inhibitor of all three
VEGF receptors.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 RCC4. Tivozanib has been investigated in several
tumor types, including renal cell, hepatocellular, colorectal,
ovarian and breast cancers.
About Durvalumab
Durvalumab (IMFINZI®) is a human monoclonal antibody that binds
to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80,
countering the tumor's immune-evading tactics and releasing the
inhibition of immune responses.
Imfinzi is also approved for previously-treated patients with
advanced bladder cancer in 10 countries, including the US.
As part of a broad development programme, Imfinzi is also being
tested as a monotherapy and in combination with tremelimumab, an
anti-CTLA4 monoclonal antibody and potential new medicine, as a
treatment for patients with NSCLC, small cell lung cancer, bladder
cancer, head and neck cancer, liver cancer, cervical cancer,
biliary tract cancer and other solid tumours.
About AVEO
AVEO Pharmaceuticals is a biopharmaceutical company seeking to
advance targeted medicines for oncology and other unmet medical
needs. The Company’s lead candidate is tivozanib, a potent,
selective, long half-life inhibitor of vascular endothelial growth
factor 1, 2 and 3 receptors, which AVEO is working to develop and
commercialize in North America as a treatment for renal cell
carcinoma (RCC), hepatocellular carcinoma (HCC) and other cancers.
Tivozanib (FOTIVDA®) is approved by the European Commission for the
treatment of adult patients with advanced RCC in the European Union
plus Norway, New Zealand, and Iceland. AVEO is leveraging or seeks
to leverage partnerships to develop and commercialize its pipeline
of products and product candidates, including tivozanib in oncology
and other indications in various geographies, and ficlatuzumab (HGF
MAb) in head and neck cancer, pancreatic cancer and acute myeloid
leukemia. AVEO’s earlier-stage pipeline includes AV-203 (anti-ErbB3
MAb), AV-380 (GDF15 MAb) and AV-353 (Notch 3 MAb) for various
oncology indications.
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,” “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 RCC; the advancement of
AVEO’s pipeline; the potential efficacy, safety, and tolerability
of tivozanib, as a single agent and in combination with other
therapies in several indications, such as RCC and HCC, including
without limitation AVEO’s expectations regarding the potential
benefit of tivozanib and durvalumab as combination therapy to treat
HCC; 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: 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.
4.
Barthelemy et al. ESMO 2018. Poster 878P.
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version on businesswire.com: https://www.businesswire.com/news/home/20190930005218/en/
AVEO: David Pitts, Argot Partners (212) 600-1902
aveo@argotpartners.com
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