TIVO-1 is the First Registration Trial to Compare an Investigational
Agent to an Approved VEGF Therapy in First-line RCC
AVEO Conference Call Today at 8:30 a.m. ET
CAMBRIDGE, Mass. & TOKYO--(BUSINESS WIRE)--Jan. 3, 2012--
AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO) and Astellas Pharma Inc. (TSE:
4503) today announced that tivozanib demonstrated superiority over
sorafenib in the primary endpoint of progression-free survival (PFS) in
TIVO-1, a global, randomized Phase 3 clinical trial evaluating the
efficacy and safety of investigational drug tivozanib compared to
sorafenib in 517 patients with advanced renal cell carcinoma (RCC).
TIVO-1 is the first registration study in first-line RCC that is
comparing an investigational agent against an approved VEGF therapy.
All patients in TIVO-1 had clear cell RCC, had undergone a prior
nephrectomy, and had not previously been treated with either a VEGF or
mTOR therapy. Based on the top-line analysis of events in TIVO-1,
determined by a blinded, independent review committee, key top-line
findings include:
-
tivozanib demonstrated a statistically significant improvement in PFS
with a median PFS of 11.9 months compared to a median PFS of 9.1
months for sorafenib in the overall study population
-
tivozanib demonstrated a statistically significant improvement in PFS
with a median PFS of 12.7 months compared to a median PFS of 9.1
months for sorafenib in the pre-specified subpopulation of patients
who were treatment naïve (no prior systemic anti-cancer therapy); this
subpopulation was approximately 70% of the total study population
-
tivozanib demonstrated a well-tolerated safety profile consistent with
the Phase 2 experience; the most commonly reported side effect was
hypertension, a well established on-target and manageable effect of
VEGFR inhibitors
Based on these data, AVEO and Astellas currently plan to submit for
marketing approval of tivozanib in the United States and Europe in 2012,
subject to final collection and analyses of all available data from the
trial.
“We are very pleased by these results, especially the PFS benefit
demonstrated in the treatment naïve population, which represents the
most significant market opportunity for tivozanib,” said Tuan Ha-Ngoc,
president and chief executive officer, AVEO. “In addition, we were
delighted with the favorable safety profile observed in TIVO-1. We would
like to acknowledge the investigators and patients who participated in
TIVO-1 for their important contributions and commitment to the treatment
of patients with RCC.”
The study participants continue to be observed to gather additional data
for further analyses. AVEO and Astellas plan to submit detailed findings
from TIVO-1 for presentation at the 2012 Annual Meeting of the American
Society of Clinical Oncology (ASCO) being held June 1-5, 2012 in Chicago.
“We are delighted with the outcome of TIVO-1 and to be collaborating
with AVEO on tivozanib at this critical juncture,” said Steven Ryder,
M.D., president, Astellas Pharma Global Development. “Tivozanib is an
important asset to our strategy of becoming a global category leader in
oncology. We look forward to working closely with our global partner
AVEO on next steps for regulatory filings for RCC and advancing clinical
development of tivozanib in colorectal cancer and other solid tumors.”
AVEO Conference Call Information
AVEO will hold a conference call to discuss the top-line results of the
TIVO-1 trial today at 8:30 a.m. ET. The call can be accessed by dialing
1-866-825-3354 (domestic) or 1-617-213-8063 (international) five minutes
prior to the start of the call and providing the passcode 17542026. A
replay of the call will be available approximately two hours after the
completion of the call and can be accessed by dialing 1-888-286-8010
(domestic) or 1-617-801-6888 (international), providing the passcode
21404848. The replay of the call will be available for two weeks from
the date of the live call.
A live, listen-only webcast of the conference call can also be accessed
by visiting the investors section of the AVEO website
at investor.aveopharma.com. A replay of the webcast will be archived on
the company's website for two weeks following the call.
About Renal Cell Carcinoma
Advanced RCC, or kidney cancer, is the ninth most commonly diagnosed
cancer in men and women in the U.S.1 Worldwide it is
estimated that more than 250,000 people are diagnosed and more than
100,000 people die from the disease each year.2 RCC accounts
for 90 percent of all malignant kidney tumors.3 Despite
advances in RCC therapies, significant unmet need persists.
About Tivozanib
Tivozanib is a potent, selective and continuous inhibitor of all
three vascular endothelial growth factor (VEGF) receptors that is
designed to optimize VEGF blockade while minimizing off-target
toxicities. Tivozanib is an oral, once-daily, investigational tyrosine
kinase inhibitor for which positive top-line results from a Phase 3
clinical study in advanced renal cell carcinoma have been reported, and
is being evaluated in other tumors.
About the AVEO/Astellas Collaboration
In February 2011, AVEO and Astellas entered into a worldwide agreement
outside of Asia to develop and commercialize tivozanib for the treatment
of a broad range of cancers. Tivozanib, AVEO's lead investigational
drug, is a potent, selective and continuous inhibitor of all
three vascular endothelial growth factor (VEGF) receptors that is
designed to optimize VEGF blockade while minimizing off-target
toxicities. Subject to regulatory approval, AVEO will lead
commercialization of tivozanib in North America and Astellas will lead
commercialization of tivozanib in the European Union (EU). AVEO and
Astellas are evaluating tivozanib in clinical trials in multiple solid
tumors; updates on the progress of those trials are expected to be
available in the coming months.
About AVEO
AVEO Pharmaceuticals (NASDAQ: AVEO) is a cancer therapeutics company
committed to discovering, developing and commercializing targeted
therapies to impact patients’ lives. AVEO’s proprietary Human Response
Platform™ provides the company unique insights into cancer biology and
is being leveraged in the discovery and clinical development of its
cancer therapeutics. For more information, please visit the company’s
website at www.aveopharma.com.
About Astellas
Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical
company dedicated to improving the health of people around the world
through the provision of innovative and reliable pharmaceuticals.
Astellas has approximately 16,800 employees worldwide. The organization
is committed to becoming a global category leader in Urology, Immunology
including Transplantation and Infectious Diseases, Oncology,
Neuroscience and DM Complications and Metabolic Diseases. For more
information on Astellas Pharma Inc., please visit the company website at
www.astellas.com/en.
AVEO Cautionary Note Regarding Forward-Looking Statements
Any statements in this press release about AVEO’s future
expectations, plans and prospects, including statements about: the
potential efficacy and safety of tivozanib; the anticipated regulatory
filings related to tivozanib; making tivozanib available to patients in
the future; advancement of the tivozanib clinical development plan in
tumors other than RCC, tivozanib’s therapeutic potential, as both a
single agent and in combination with other anti-cancer therapies; the
potential of AVEO’s cancer biology platform to offer a unique advantage
in oncology drug development; and other statements containing the words
"believes," "anticipates," "plans," "expects," “potential,” "will" and
similar expressions, constitute forward-looking statements within the
meaning of The Private Securities Litigation Reform Act of 1995. Actual
results may differ materially from those indicated by such
forward-looking statements as a result of various important factors,
including risks relating to: AVEO’s ability to successfully research,
develop and obtain and maintain regulatory approvals for tivozanib and
its other product candidates, including risks relating to its ability to
successfully advance regulatory filings both domestically and abroad
relating to the use of tivozanib for the treatment of RCC; the
possibility that favorable historical preclinical and clinical trial
results may not be predictive of the results in future preclinical and
clinical trials; AVEO’s ability to obtain and maintain adequate
protection for intellectual property rights relating to its product
candidates and technologies; AVEO’s ability to successfully maintain its
strategic collaborations, including its collaboration with Astellas for
the development and commercialization of tivozanib; unplanned operating
expenses; AVEO’s ability to raise substantial additional funds to
achieve its goals, including with respect to the further development of
tivozanib; competition; general economic and industry conditions; and
other factors discussed in the "Risk Factors" section of AVEO’s Annual
Report on Form 10-K filed with the Securities and Exchange Commission,
and in other filings that AVEO periodically makes with the SEC. In
addition, the forward-looking statements included in this press release
represent AVEO’s views as of the date of this press release. AVEO
anticipates that subsequent events and developments will cause its views
to change. However, while AVEO may elect to update these forward-looking
statements at some point in the future, AVEO specifically disclaims any
obligation to do so. These forward-looking statements should not be
relied upon as representing AVEO’s views as of any date subsequent to
the date of this press release.
1 U.S. Cancer Statistics Working Group. United States Cancer
Statistics: 1999–2007 Incidence and Mortality Web-based Report. Atlanta:
U.S. Department of Health and Human Services, Centers for Disease
Control and Prevention and National Cancer Institute; 2010. Available
at: www.cdc.gov/uscs.
2 Cancer Research UK http://info.cancerresearchuk.org/cancerstats/world/the-global-picture/#Common;
http://publications.cancerresearchuk.org/downloads/Product/cs_pdf_worldwide_2011.pdf
3 Motzer RJ, et al. JCO 2009- Sutent.
Source: AVEO Pharmaceuticals, Inc. and Astellas Pharma Inc.
AVEO Pharmaceuticals
Investor Relations:
Monique Allaire,
617-299-5810
AVEO Pharmaceuticals
or
Media Relations:
Dan
Budwick, 973-271-6085
Pure Communications, Inc.
or
Astellas
Pharma Inc.
Jenny Kite, 847-317-5405
Astellas US LLC
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