AVEO Oncology Announces Phase 1/2 TiNivo Trial of Tivozanib and Opdivo® (nivolumab) in RCC Advances to Phase 2
June 08 2017 - 7:00AM
Business Wire
AVEO Oncology (NASDAQ:AVEO) today announced that its Phase 1/2
AVEO-sponsored TiNivo trial evaluating tivozanib in combination
with Bristol-Myers Squibb’s anti-PD-1 therapy, Opdivo® (nivolumab),
in subjects with advanced renal cell carcinoma (RCC) has progressed
to the Phase 2 portion of the trial.
Advancement of the study into the Phase 2 expansion follows the
successful completion of the Phase 1 dose escalation portion of the
trial, where tivozanib was administered in two escalating dose
cohorts in combination with nivolumab at a constant 240 mg every 2
weeks (n=6). The combination was well tolerated to the full dose
and schedule of single agent tivozanib, with no dose limiting
toxicities. The full dose tivozanib regimen of 1.5 mg daily for 21
days, followed by a 7 day rest period, is the recommended Phase 2
dose (RP2D) for the expansion portion of the trial, which is
expected to enroll up to an additional 20 subjects. The TiNivo
study is being led by the Institut Gustave Roussy in Paris under
the direction of Bernard Escudier, MD, Chairman of the
Genitourinary Oncology Committee. Phase 1 results from the ongoing
study will be submitted for presentation at an upcoming scientific
meeting.
“The promise of delivering synergistic activity by combining
VEGF TKIs and PD-1s in renal cell carcinoma hinges on the
tolerability of the combination,” said Dr. Escudier. “Tivozanib has
a uniquely favorable tolerability profile as demonstrated in past
single agent and combination studies. These initial results are
very promising in that we see both evidence of a uniquely tolerable
combination as well as early and meaningful activity. I look
forward to enrolling the expansion cohort and to establishing a
broader understanding for the potential of this compelling
combination.”
“Together with the longest progression free survival from a
Phase 3 first line RCC study, tivozanib’s tolerability is distinct
from other VEGF TKIs, which we believe better position it for use
in combination with immunotherapy and other agents,” said Michael
Bailey, president and chief executive officer of AVEO. “As our
registration strategy for single agent tivozanib reaches key
inflection points, with a European regulatory decision expected in
the near-term and readout of our US registration-directed TIVO-3
study expected in the first quarter of 2018, our attention is
increasing on tivozanib immuno-oncology combinations that have the
potential to deliver significantly improved outcomes and
tolerability to patients. The TiNivo trial is an important first
step in this effort, and we share Dr. Escudier’s enthusiasm for the
completion of this trial.”
About Tivozanib
Tivozanib is an oral, once-daily, vascular endothelial growth
factor (VEGF) tyrosine kinase inhibitor (TKI). 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. Tivozanib has been investigated in
several tumors types, including renal cell, 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). 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, statement about: the potential safety, tolerability and
clinical benefits of combining VEGF TKIs and PD-1s in general, and
tivozanib and nivolumab specifically; plans relating to the
expansion portion of the TiNivo trial; the expected timing of
top-line data readouts in TIVO-3; AVEO's expectations regarding the
timing for a registration decision in the EU for tivozanib; plans
and strategies of AVEO and its partners and the potential
achievement by AVEO and its partners of clinical, regulatory,
commercial, manufacturing and other development goals and
milestones; and the potential safety, efficacy, tolerability and
other benefits of tivozanib in the treatment of renal cell
carcinoma as a single agent or in combination with other therapies.
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 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 licensees, to
demonstrate to the satisfaction of applicable regulatory agencies
the safety, efficacy and clinically meaningful benefit of AVEO's
product candidates, including without limitation risks relating to
the ability of AVEO’s licensee to successfully obtain approval of
its MMA for tivozanib in the EU. AVEO faces other risks relating to
its business as well, including 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
ongoing 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;
unplanned capital requirements; adverse general economic and
industry conditions; competitive factors; and those risks discussed
in the section titled "Risk Factors" in AVEO's most recent Annual
Report on Form 10-K, its quarterly reports on Form 10-Q and its
other filings with the SEC. 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170608005337/en/
AVEO:Argot PartnersDavid Pitts,
212-600-1902aveo@argotpartners.com
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