– Results Suggest Additive or Synergistic
Activity in Both Treatment Naïve and Previously Treated Patients
–
-Tivozanib-Nivolumab Combination Generally Well
Tolerated -
– Data to be Presented at the ESMO 2019 Annual
Congress –
AVEO Oncology (NASDAQ: AVEO) and EUSA Pharma
today announced the upcoming presentation of final results from the
Phase 2 portion of the TiNivo study, a Phase 1b/2 multicenter trial
of oral (PO) tivozanib (FOTIVDA®), AVEO’s once-daily, potent and
selective vascular endothelial growth factor receptor tyrosine
kinase inhibitor (VEGFR-TKI), in combination with intravenous (IV)
nivolumab (OPDIVO®, Bristol-Myers Squibb), an immune checkpoint, or
PD-1, inhibitor, for the treatment of advanced or metastatic renal
cell carcinoma (RCC). The results will be presented at the European
Society of Medical Oncology (ESMO) 2019 Annual Congress, in a
poster presentation titled “TiNivo: Tivozanib combined with
nivolumab results in prolonged progression free survival in
patients with metastatic renal cell carcinoma (mRCC). Final
Results.” (Presentation 947P).
The Phase 1b/2 study enrolled a total of 28 patients. The Phase
2 portion of the study (n=22) 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 1b portion of the study (n=6),
in combination with IV nivolumab (240 mg every 2 weeks). The
combination was generally well tolerated and showed additive or
synergistic activity for objective response rate and progression
free survival (PFS) in both treatment naïve and previously treated
patients with mRCC. Overall median PFS for the 25 patients treated
at the study’s full dose and schedule was 18.9 months (95% CI:
16.4; NR). Median PFS for previously untreated patients (n=12) was
18.5 months, while median PFS for previously treated patients
(n=13) has not yet been reached as of the August 27, 2019 data
cutoff date. An objective response rate was observed in 56% of
patients (complete responses + partial responses), including one
treatment naïve patient (1/12) achieving a complete response, and
disease control (complete response + partial response + stable
disease) was observed in 96% of patients. The most common
treatment-related Grade 3/4 adverse event was hypertension.
An abstract of these data is currently available via the ESMO
2019 Annual Congress website. A copy of the poster will be
available following the presentation at www.aveooncology.com, or
further information can be obtained via EUSA Pharma Medical
Information.
“Tivozanib has shown a favorable adverse event profile, thanks
to its unique selectivity, that we believe has the potential to
make it the ideal candidate for combination with an immunotherapy,
like nivolumab, in metastatic RCC,” said Doctor Bernard Escudier,
MD, ex-Chairman of the Genitourinary Oncology Committee, Gustave
Roussy, and lead investigator of the study. “With considerable
follow up now complete in the TiNivo study, the long median PFS
suggests a favorable durability of response, particularly in the
second line. I look forward to seeing this potential explored in a
larger outcome study in the near future.”
“We are pleased with the level of antitumor activity we are
seeing with this combination both in treatment naive and previously
treated patients,” said Michael Bailey, president and chief
executive officer of AVEO. “We believe these data highlight the
potentially unique benefits of a tivozanib-immunotherapy
combination in a refractory patient population, a setting in which
conclusive immunotherapy-TKI combination studies have yet to be
conducted. We look forward to working with our partners at EUSA to
determine potential next steps for the tivozanib-immunotherapy
combination.”
“The data arising from combination studies with checkpoint
inhibitors demonstrates the considerable potential for tivozanib in
metastatic RCC,” said Lee Morley, chief executive officer of EUSA
Pharma. “EUSA continue to seek reimbursement and launch tivozanib
across the EU in line with its EMA approval as monotherapy in the
first line setting where its efficacy and favorable tolerability
profile continues to provide benefits to patients, and are excited
by the prospect of further development of tivozanib as part of a
future IO-TKI treatment option.”
Presentation Details
Title: TiNivo: Tivozanib combined with nivolumab results
in prolonged progression free survival in patients with metastatic
renal cell carcinoma (mRCC). Final Results. Presenter:
Philippe Barthelemy, Medical Oncology Department, Hôpitaux
Universitaires de Strasbourg, Strasbourg, FR Presentation
Number: 947P Date and Time: September 30, 2019, 12:20
p.m. CEST Location: Poster Area (Hall 4)
About Tivozanib
Tivozanib (FOTIVDA®) is an oral, once-daily, vascular
endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI)
discovered by Kyowa Kirin and 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,
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
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 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.
About EUSA Pharma
Founded in March 2015, EUSA Pharma is a world-class
biopharmaceutical company focused on oncology and rare disease. The
company has extensive commercial operations in the United States
and Europe, alongside a direct presence in select other markets
across the globe. EUSA Pharma is led by an experienced management
team with a strong record of building successful pharmaceutical
companies, and is supported by significant funding raised from
leading life science investor EW Healthcare Partners. For more
information please visit www.eusapharma.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 in combination with an
immunotherapy like nivolumab in metastatic RCC; 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
- 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/20190923005230/en/
AVEO Contact: David Pitts, Argot Partners (212) 600-1902
aveo@argotpartners.com
EUSA Pharma Contacts: Lee Morley Chief Executive EUSA
Pharma Tel: +44 (0)330 5001140
Rob Budge RJB Communications Tel: +44 (0)1865 760969 Mobile: +44
(0)7710 741241
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