Data Presented at the 2018 American Society of
Clinical Oncology Genitourinary Cancers Symposium (ASCO GU)
AVEO Oncology (NASDAQ: AVEO) and EUSA Pharma today announced the
presentation of preliminary results from the Phase 2 portion of the
TiNivo study, a Phase 1b/2 multicenter trial of oral (PO) tivozanib
(FOTIVDA®) in combination with intravenous (IV) nivolumab (OPDIVO®,
Bristol-Myers Squibb), an immune checkpoint, or PD-1, inhibitor,
for the treatment of metastatic renal cell carcinoma (mRCC). The
results were presented today at the 2018 American Society of
Clinical Oncology’s Genitourinary Cancers Symposium (ASCO GU), in a
poster presentation titled “Tivozanib combined with nivolumab:
Phase Ib/II study in metastatic renal cell carcinoma (mRCC)”
(Abstract 618). A copy of the presentation is available at
www.aveooncology.com or further information can be obtained via
EUSA Pharma Medical Information.
The Phase 1/2 study has enrolled a total of 27 patients. The
Phase 2 portion of the study (n=21) was designed to assess the
safety, tolerability, and anti-tumor activity of the full dose and
schedule of PO tivozanib (1.5 mg/QD for 21 days followed by a 7-day
rest period), as established in the Phase 1 portion of the study
(n=6), in combination with IV nivolumab (240 mg every 2 weeks). The
combination was generally well tolerated. Treatment-related Grade
3/4 adverse events occurred in 44% of patients, the most common of
which was hypertension.
Preliminary efficacy was assessed in 14 patients treated with
the full dose and schedule of PO tivozanib in combination with IV
nivolumab and enrolled at least 4 months prior to the data cutoff
date. Of these, seven had received at least one prior systemic
therapy. An objective response rate was observed in 64% of patients
(partial responses), and a disease control rate (partial response +
stable disease) was observed in 100% of patients. At the time of
data collection, 11 of 14 evaluable patients remained on study.
“These preliminary data continue to support the rationale for
choosing a high-specificity VEGF inhibitor TKI, such as tivozanib,
in building upon the benefit of immune checkpoint therapy in renal
cancer,” said Doctor Bernard Escudier, MD, ex-Chairman of the
Genitourinary Oncology Committee, Gustave Roussy, and lead
investigator of the study. “Combining VEGF TKIs and immune
checkpoint inhibitors has been hampered by toxicity, potentially
emerging with the use of other TKIs, while minimal off-target
toxicities have been observed with tivozanib in this combination.
These results open the possibility for triple-combination therapy
using tivozanib, nivolumab and ipilimumab, an immune system
activator targeting CTLA-4.”
“We believe that VEGF TKI-immunotherapy combinations are the
obvious next step in the evolution of treatment within mRCC, which
underscores the need for a VEGF therapy with best-in-class safety,”
said Michael Needle, M.D., chief medical officer of AVEO. “The
preliminary activity and favorable safety profile observed thus far
in the TiNivo study are encouraging and support the further
exploration of tivozanib combinations with immuno-oncology
therapies. In addition to the TiNivo study, we continue to look
forward to topline data in the second quarter of 2018 from our
Phase 3 TIVO-3 study, which, together with the previously completed
TIVO-1 trial of tivozanib in the first line treatment of mRCC, is
designed to support a request for regulatory approval of tivozanib
in North America as a first and third line treatment for mRCC.”
Lee Morley, EUSA Pharma’s Chief Executive Officer said, “We are
excited by the continued development potential for tivozanib and
the data arising from initial studies in combination with
checkpoint inhibitors. As an effective TKI with a favorable
tolerability profile, we are already launching tivozanib across the
EU in line with its recent approval as monotherapy in the first
line setting, and on the basis of the TiNivo study, we look forward
to the potential to develop new innovative treatment options for
patients in the future.”
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 models, enabling
potentially enhanced activity when used in combination with immune
modulating therapy. As part of a North American registration plan,
Tivozanib is currently being studied in the Phase 3 TIVO-3 trial, a
randomized, controlled, multi-center, open-label study to compare
tivozanib to sorafenib in subjects with refractory advanced RCC.
Tivozanib has been investigated in several tumors types, including
renal cell, hepatocellular, colorectal and breast cancers.
About AVEO
AVEO Oncology (AVEO) is a biopharmaceutical company dedicated to
advancing a broad portfolio of targeted therapeutics for oncology
and other areas of unmet medical need. The Company is focused on
seeking to develop and commercialize its lead candidate tivozanib,
a potent, selective, long half-life inhibitor of vascular
endothelial growth factor 1, 2 and 3 receptors, in North America as
a treatment for renal cell carcinoma and other cancers. AVEO is
leveraging multiple partnerships aimed at developing and
commercializing tivozanib in oncology indications outside of North
America, and at progressing its pipeline of novel therapeutic
candidates in cancer and cachexia (wasting syndrome). Tivozanib
(FOTIVDA®) is approved by the European Commission for the treatment
of adult patients with advanced renal cell carcinoma (RCC) in the
European Union plus Norway and Iceland. For more information,
please visit the company’s website at www.aveooncology.com.
About EUSA Pharma
Founded in March 2015, EUSA Pharma is a specialty pharmaceutical
company with a focus on oncology and oncology supportive care. The
company has commercial operations in the US and Europe, and a wider
distribution network in approximately 40 countries around the
world. EUSA Pharma is led by an experienced management team with a
strong record of building successful specialty pharmaceutical
companies, and is supported by significant funding raised from
leading life science investor EW Healthcare Partners. For more
information visit www.eusapharma.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: the expected benefits of combining TKIs
and checkpoint inhibitors; the expected timeline for reporting
topline data from TIVO-3; and AVEO’s strategy, prospects, plans and
objectives, including as they pertain specifically to tivozanib.
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 to enter into and
maintain its third party collaboration and license agreements, and
its ability, and the ability of its licensees and other partners,
to achieve development and commercialization objectives under these
arrangements; AVEO’s ability, and the ability of its collaborators
and licensees, to demonstrate to the satisfaction of applicable
regulatory agencies the safety, efficacy and clinically meaningful
benefit of AVEO’s product candidates, including tivozanib. AVEO
faces other risks relating to its business as well, including risks
relating to its ability to successfully enroll and complete
clinical trials, including the TIVO-3 and TiNivo studies; AVEO’s
ability to achieve and maintain compliance with all 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 and
technologies; developments, expenses and outcomes related to AVEO’s
shareholder litigation; 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 section titled “Risk Factors” and “Management’s
Discussion and Analysis of Financial Condition and Results of
Operations—Liquidity and Capital Resources” included in AVEO’s
Annual Report on Form 10-K for the year ended December 31, 2016,
its quarterly reports on Form 10-Q and in other filings that AVEO
may make with the SEC in the future. The forward-looking statements
in this press release represent AVEO’s views as of the date of this
press release. AVEO anticipates that 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.
References
1. Fotivda (Tivozanib) SmPC August 20172. Motzer RJ, Nosov D,
Eisen T, et al. J Clin Oncol 2013; 31(30): 3791-9.
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version on businesswire.com: http://www.businesswire.com/news/home/20180210005043/en/
AVEO:Argot PartnersDavid Pitts,
212-600-1902aveo@argotpartners.comorEUSA:EUSA PharmaLee
Morley, +44 (0)330 5001140Chief Executive
AVEO Pharmaceuticals (NASDAQ:AVEO)
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