Announce Expected Initiation of an
Investigator-Initiated, Randomized, Phase 2, Multicenter Trial of
Ficlatuzumab and Cetuximab in HNSCC in 2H 2017
AVEO Announces Trial in Progress Poster Also
Presented Highlighting Phase 3 TIVO-3 Study of Tivozanib in RCC
AVEO Oncology (NASDAQ: AVEO) and Biodesix, Inc., co-development
partners, today announced the presentation of results from two
investigator-sponsored Phase 1 studies of ficlatuzumab at the
2017 American Society of Clinical Oncology (ASCO) Annual
Meeting taking place in Chicago, Illinois. The first is a study of
ficlatuzumab in combination with the EGFR inhibitor cetuximab in
patients with cetuximab-resistant, metastatic head and neck
squamous cell carcinoma (HNSCC), and the second is a study of
ficlatuzumab in combination with high-dose cytarabine in patients
with high risk relapsed or refractory acute myeloid leukemia (AML).
Ficlatuzumab is a humanized IgG1 antibody that binds to the HGF
ligand with high affinity and specificity to inhibit the biological
activities of the HGF/c-Met pathway.
“HGF is an important pathway for resistance and proliferation in
a number of cancer models, serving as a means to overcome EGFR
inhibition in HNSCC, and as an adverse prognostic factor in AML,”
said Michael Needle, chief medical officer of AVEO. “In a Phase 1
study in patients with cetuximab-resistant recurrent/metastatic
HNSCC, the addition of ficlatuzumab to the EGFR-targeted antibody
cetuximab resulted in a disease control rate of 67%, and prolonged
progression free and overall survival compared to historical
controls, in addition to being well tolerated. With continued,
strong investigator support, we look forward to the expected
initiation, in the second half of 2017, of a randomized, Phase 2,
multicenter, investigator-initiated trial to confirm these
findings. We also look forward to the completion of the ongoing
investigator-sponsored study in AML, which has demonstrated early
signs of tolerability and activity, including a 50% complete
response rate in the relapsed/refractory setting.”
“Median PFS for cetuximab monotherapy in the naïve setting is
only two months, as with the median PFS for nivolumab or
single-agent chemotherapy in the platinum-refractory setting,
suggesting an urgent need for new therapies,” said Julie E. Bauman,
MD, MPH, Professor of Medicine, Chief, Division of
Hematology/Oncology, Associate Director of Translational Research,
University of Arizona Cancer Center. “Although a small cohort, the
fact that we observed significant responses and PFS of 6 months in
a refractory population in this study suggests important biologic
activity.”
AVEO also announced that a Trials in Progress presentation
highlighting the ongoing Phase 3, randomized, controlled,
multi-center, open-label TIVO-3 study comparing tivozanib, the
Company’s potent, selective, long half-life inhibitor of all three
vascular endothelial growth factor (VEGF) receptors, to sorafenib
in subjects with refractory advanced renal cell carcinoma.
The posters are available at www.aveooncology.com. Details of
the posters are below:
Phase I study of the anti-HGF mononclonal antibody (mAb),
ficlatuzumab, and cetuximab in cetuximab-resistant,
recurrent/metastatic (R/M) head and neck squamous cell carcinoma
(HNSCC)
Presenter: Julie E. Bauman, MD, MPH, Chief, Division of
Hematology and Oncology, Associate Director, Translational
Research, University of Arizona Cancer CenterAbstract
Number: 6038Session: Head and Neck CancerDate and
Time: Monday, June 5, 2017, 1:15-4:45 PM CT
In this phase I study, 12 patients with R/M HNSCC who had
disease recurrence within 6 months of cetuximab radiation or
progression within 6 months of cetuximab treatment in the recurrent
metastatic setting were treated with a ficlatuzumab/cetuximab
combination. The primary objective was to establish the recommended
Phase 2 dose (RP2D) for ficlatuzumab, with the secondary objectives
being to evaluate preliminary clinical efficacy of RP2D and to
evaluate the relationship between preliminary efficacy and 1)
baseline tumor p-Met expression and 2) serum Veristrat.
Cetuximab was administered every 2 weeks at 500 mg/m2, and
ficlatuzumab dose tiers were 10 mg/kg (tier 1) or 20 mg/kg IV every
2 weeks (tier 2), with inter-patient escalation or de-escalation
based on cumulative dose-limiting toxicities (DLT). RP2D was set at
tier 2 if no DLTs were observed after 8 enrolled patients, with
expansion continuing to 12 patients. Three patients were treated at
dose tier 1 and 9 at dose tier 2. The RP2D is ficlatuzumab 20 mg/kg
and cetuximab 500 mg/m2 every 2 weeks. The overall response rate
was 17% (1 PR at tier 1; 1 at tier 2) and 50% of patients had
stable disease, for a disease control rate of 67%. Median PFS and
OS at RP2D were 6.0 mos (90% CI=2 mos-NR) and 8.2 mos (90% CI=2.7
mos-NR).
CyFi: A phase I study exploring the role of cMET pathway
inhibition with ficlatuzumab (Fi) combined with high-dose
cytarabine (Cy) in patients with high risk relapsed or refractory
acute myeloid leukemia (AML)
Presenter: Charalambos (Babid) Andreadis, MD, Hematologic
Malignancies and Blood and Marrow Transplantation Program,
University of California, San FranciscoAbstract Number:
7040Session: Hematologic Malignancies – Leukemia,
Myelodyplastic Syndromes, and AllotransplantDate and Time:
Monday, June 5, 2017, 8:00-11:30 AM CT
In this ongoing study, the safety and tolerability of
ficlatuzumab in combination with cytarabine was assessed in 9
patients with high risk relapsed or refractory acute myeloid
leukemia. Ficlatuzumab was given in escalated dosing of 10, 15, or
20 mg/kg for 4 doses every 2 weeks, starting on day 0, and
cytarabine was given at a fixed dose of 2g/m2 on days 2-7, using a
3x3 design. Dose-limiting toxicity (DLT) was defined based on
toxicities attributable to the combination and unexpected with AML
or high-dose cytarabine. Peripheral blood mononuclear cells and
serum were collected at defined time points to assess HGF levels
and activation of the c-Met pathway. The results showed no DLTs,
and the combination has proven well tolerated. The most frequent
grade 3-4 adverse events were febrile neutropenia (56%),
ventricular tachycardia (22%), respiratory distress (11%),
electrolyte disturbance (11%). There was 1 death from sepsis and
multi-organ failure on day 23, during count recovery. Of the 8
evaluable patients, 4 achieved a CR (50%), all in the 2nd dose
cohort. All patients had detectable circulating HGF levels at
baseline and levels increased following exposure to Fi by an
average of 193% (p value). Baseline levels or change from baseline
were not associated with response.
Title: Tivo-3: A phase 3, randomized, controlled,
multi-center, open-label study to compare tivozanib hydrochloride
to sorafenib in subjects with refractory advanced renal cell
carcinoma (RCC)Presenter: Brian I. Rini, MD, FACP,
Professor of Medicine, Lerner College of Medicine, Leader, GU
Program, Department of Hematology and Oncology, Cleveland Clinic
Taussig Cancer InstituteAbstract Number:
TPS4600Session: Genitourinary (Non-prostate) CancerDate
and Time: Sunday, June 4, 2017, 8:00-11:30 AM CT
About Ficlatuzumab
Ficlatuzumab (formerly known as AV-299) is a potent hepatocyte
growth factor (HGF) inhibitory antibody that binds to the HGF
ligand with high affinity and specificity to inhibit HGF/c-Met
biological activities. AVEO and Biodesix, Inc. currently divide all
worldwide development costs for ficlatuzumab and are seeking a
commercialization partner. Ficlatuzumab is currently being
evaluated in investigator-sponsored trials in squamous cell
carcinoma of the head and neck (HNSCC) and acute myeloid leukemia
(AML).
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.
About Biodesix
Biodesix® is a molecular diagnostics company advancing the
development of innovative, multi-omic blood tests in oncology to
enable precision medicine. Biodesix discovers, develops and
commercializes multivariate protein and genomic liquid biopsy
tests, including the GeneStrat® and VeriStrat® tests, that deliver
results within 72 hours. The company is changing the standard of
care by providing physicians with diagnostic tests and with the
Biodesix Lung Reflex™ testing strategy, for better therapeutic
guidance, more accurate prognosis and enhanced disease monitoring
to improve patient outcomes. At the forefront of personalized
medicine, Biodesix is developing new tests to identify patients who
may benefit from immunotherapies. In addition to developing novel
diagnostics independently, the company partners with biotechnology
and pharmaceutical companies to develop companion diagnostics for
use with therapeutic agents.
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 safety, efficacy and clinical benefits
of ficlatuzumab in HNSCC and AML; plans to initiate an
investigator-initiated, randomized, phase 2, multicenter trial of
ficlatuzumab and cetuximab in HNSCC in the second half of 2017;
expected completion of the ongoing investigator sponsored study of
ficlatuzumab in AML; AVEO’s and its collaborators’ future
discovery, development and commercialization plans and efforts,
including without limitation with respect to tivozanib,
ficlatuzumab and AVEO’s other programs and platforms; and AVEO’s
strategy, prospects, plans and objectives. 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 agreements; the ability of AVEO and 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;
AVEO’s ability and the ability of investigators and collaborators
to successfully enroll and complete clinical trials, including the
ficlatuzumab, 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, including those goals pertaining to the
development and commercialization of ficlatuzumab and 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170605005934/en/
AVEO:Argot PartnersDavid Pitts,
212-600-1902aveo@argotpartners.com
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