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Celldex Therapeutics Announces Positive Three-Year Survival Data for Rindopepimut Phase 2 Clinical Program
NEEDHAM, Mass. --(Business Wire)--
Celldex
Therapeutics, Inc. (NASDAQ: CLDX) announced today the presentation
of three-year survival data from the Phase 2 rindopepimut clinical
program in EGFRvIII-positive glioblastoma-a more aggressive form of
glioblastoma typically associated with reduced long-term survival in
comparison to the glioblastoma population as a whole. Across three Phase
2 studies of rindopepimut, survival data remains consistent and suggests
a substantial and continuing survival benefit in comparison to
independent control datasets (see chart below) at the median and at
three years. In the multi-center Phase 2 ACT III study, the median
overall survival is 24.6 months from diagnosis (21.8 months from study
entry) and overall survival is 26% at three years. In the Phase 2 ACT II
study, the median overall survival is 24.4 months from diagnosis (20.5
months from study entry) and overall survival is 23% at three years. In
the Phase 2 ACTIVATE study, the median overall survival is 24.6 months
from diagnosis (20.4 months from study entry) and overall survival is
33% at three years.
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Rindopepimut Overall Survival (OS) Across Three Phase 2 Studies
in EGFRvIII-Positive Glioblastoma vs Independent Control Datasets
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Rindopepimut Phase 2 Studies (all data from study entry)
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Median (months)
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OS 3 years
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ACT III (n=65)
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21.8
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26%
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ACT II (n=22)
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20.5
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23%
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ACTIVATE (n=18)
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20.4
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33%
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Independent Control Datasets (all data from study entry)
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MD Anderson EGFRvIII-positive patients matched1 to
ACTIVATE patient population (n=17)
(contemporary with ACTIVATE)
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12.22
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6%
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Radiation Therapy Oncology Group (RTOG) 0525 study - all
EGFRvIII-positive patients (n=142)
(contemporary with ACT III)
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15.1
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18%
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RTOG 0525 study - all EGFRvIII-positive patients treated with
standard dose temozolomide (n=62)
(contemporary with ACT III)
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14.2
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7%
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RTOG 0525 study - EGFRvIII-positive patients matched1 to
ACT III/IV patient population (n=29)
(contemporary with ACT III)
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16
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13%
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1Controls are closely matched to rindopepimut
patient criteria including gross total resection of patient tumor and ~3
months without disease progression at time of study entry; 2In
order to provide comparable timeframes across datasets, data have been
estimated assuming study entry at three months from diagnosis.
"The long-term survival data across all three rindopepimut Phase 2
clinical trials are consistent and suggest that rindopepimut is
providing long-term survival beyond what is historically seen in this
subset of EGFRvIII-expressing glioblastoma patients-a group that
typically has more aggressive disease associated with a worse prognosis
than the general glioblastoma patient population," said John Sampson,
MD, PhD, Dr. Robert H. Wilkins and Gloria Wilkins Professor of
Neurosurgery & Associate Deputy Director, The Preston Robert Tisch Brain
Tumor Center Duke University Medical Center, Durham, NC and lead
investigator of the ACT II and ACTIVATE studies. "Based on the results
to date, I am hopeful that with continued success in the clinic,
rindopepimut has the potential to be a much needed treatment option for
patients with EGFRvIII-positive glioblastoma."
In addition to the presentation of updated survival data, Celldex also
announced the presentation of data from a retrospective analysis of
EGFRvIII expression status and associated clinical outcome in the Phase
3 Radiation Therapy Oncology Group's (RTOG) 0525 study. This analysis
was conducted by The University of Texas MD Anderson Cancer Center in
cooperation with RTOG to provide an assessment of the prognosis for
patients with EGFRvIII-positive disease contemporary with the ACT III
data.
"The RTOG 0525 data continue to demonstrate that patients with
EGFRvIII-positive glioblastoma fare worse than the general glioblastoma
patient population, particularly when it comes to long-term survival,"
said Thomas Davis, MD, Senior Vice President and Chief Medical Officer
of Celldex Therapeutics. "In line with our expectations given
improvements in both the overall standard of care and in best supportive
care, the updated historical control data demonstrate a modest
improvement in outcome compared to previous data. This improvement is
well within the bounds of what we anticipated when we designed our
ongoing Phase 3 randomized ACT IV study and provides further confidence
in the ACT IV study design."
"The results presented at SNO provide further validation for the
rindopepimut clinical program," said Anthony Marucci, President and
Chief Executive Officer of Celldex Therapeutics. "The median and
long-term survival rates are impressive in comparison to both the MD
Anderson and RTOG historical control datasets, with 23% to 33% of
patients on rindopepimut surviving to the three year mark versus 6% to
18% of patients in the historical control datasets. In addition, while
the ACT II and ACT III data continue to mature, across all three Phase 2
rindopepimut studies, approximately 15% of patients are alive at five
years compared to an expectation of 0%. These results support our belief
that rindopepimut has the potential to dramatically alter the prognosis
for patients with EGFRvIII-positive glioblastoma. To that end, we
continue to actively enroll patients in the pivotal ACT IV study with
more than 150 clinical sites around the world selected to participate
and, to date, 118 of these sites actively screening patients."
The data announced today were presented at the Society for
Neuro-Oncology's (SNO) 17th Annual Scientific Meeting and Education Day
in Washington, DC. Duane A. Mitchell, MD, PhD, Assistant Professor of
Surgery (Neurosurgery), Duke University Medical Center presented the
updated overall survival data from the rindopepimut Phase 2 ACT III, ACT
II and ACTIVATE studies in an educational session entitled
"Immunotherapy of Malignant Brain Tumors" and Michael Weller, MD,
Professor, Department of Neurology, University Hospital Zurich presented
data from a cohort of patients with EGFRvIII-positive glioblastoma that
were included in the Phase 3 Radiation Therapy Oncology Group's (RTOG)
0525 study (closed to accrual in 2008) in an educational session called
"Biomarkers and Clinical Care: are we there yet "
Rindopepimut is an investigational immunotherapeutic vaccine that
targets the tumor-specific molecule epidermal growth factor receptor
variant III (EGFRvIII). EGFRvIII is a mutated form of the epidermal
growth factor receptor (EGFR) that is only expressed in cancer cells and
not in normal tissue and is a transforming oncogene that can directly
contribute to cancer cell growth. Expression of EGFRvIII is linked to
poor long-term survival regardless of other factors such as extent of
resection and age. EGFRvIII is expressed in approximately 30% of
glioblastoma tumors. Celldex is actively enrolling two clinical studies
of rindopepimut-a Phase 3 international study called ACT IV in patients
with newly diagnosed EGFRvIII-positive glioblastoma and a Phase 2 study
called ReACT in patients with recurrent EGFRvIII-positive glioblastoma.
Drs. Sampson and Mitchell have a patent that has been licensed by
Celldex and may receive royalties related to sales of this
immunotherapeutic vaccine.
About Celldex Therapeutics, Inc.
Celldex Therapeutics is the first antibody-based combination
immunotherapy company. Celldex has a pipeline of drug candidates in
development for the treatment of cancer and other difficult-to-treat
diseases based on its antibody focused Precision Targeted Immunotherapy
(PTI) Platform. The PTI Platform is a complementary portfolio of
monoclonal antibodies, antibody-targeted vaccines and immunomodulators
used in optimal combinations to create novel disease-specific drug
candidates. For more information, please visit www.celldextherapeutics.com.
Safe Harbor Statement Under the Private Securities Litigation Reform
Act of 1995: This release contains "forward-looking statements"
made pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, including those related to the Company's
strategic focus and the future development and commercialization (by
Celldex and others) of rindopepimut (CDX-110), CDX-011, CDX-1135,
CDX-1401, CDX-1127, CDX-301, Belinostat and other products. Forward-looking
statements reflect management's current knowledge, assumptions, judgment
and expectations regarding future performance or events. Although
management believes that the expectations reflected in such statements
are reasonable, they give no assurance that such expectations will prove
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materially from those contained in the forward-looking statements.
Forward-looking statements are subject to a number of risks and
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complete the clinical trials that we have initiated or plan to initiate;
our ability to adapt APC (News - Alert) Targeting TechnologyTM
to develop new, safe and effective vaccines against oncology and
infectious disease indications; our ability to successfully complete
product research and further development of our programs; the
uncertainties inherent in clinical testing; our limited experience in
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continue to develop; our ability to protect the Company's intellectual
property; the loss of any executive officers or key personnel or
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