Full Press Release Details
ASCO Abstract No. 2021
EMBARGOED UNTIL SATURDAY, MAY 30, 2009 at 8:00 a.m. EDT
Pfizer and Celldex Therapeutics Present
Update on CDX-110 (PF-04948568) Phase 2 Brain Cancer Studies
- Updated follow-up of time to progression
and overall survival reported from Phase 2 clinical trials with CDX-110 (PF-04948568)
ORLANDO (Business Wire) May 30, 2009 Pfizer (NYSE: PFE) and Celldex
Therapeutics (NASDAQ: CLDX) today announced the presentation of updated data from
two clinical trials of CDX-110 in newly-diagnosed glioblastoma multiforme (GBM)
at the 45th Annual Meeting of the American Society of
Clinical Oncology (ASCO). CDX-110, an investigational immunotherapeutic vaccine
that targets the tumor-specific molecule, epidermal growth factor receptor
variant III (EGFRvIII), was developed by Celldex Therapeutics and is now partnered
Data from the 40 evaluable patients in ACTIVATE and ACT II continue to
suggest that vaccination with CDX-110 may be able to improve time to tumor
recurrence and overall survival when used in patients with newly-diagnosed
GBM. These data also continue to suggest
that tolerability and side effects associated with CDX-110 are minimal. These results are very encouraging and we
look forward to the results from the ongoing multi-center ACT III Phase 2 study,
said John H. Sampson, MD, PhD, Associate Deputy Director of The Preston Robert
Tisch Brain Tumor Center at Duke University Medical Center.
In this single arm Phase 2 study, 18 patients with newly diagnosed and optimally
resected EGFRvIII-positive GBM received CDX-110 as a monotherapy following completion
of chemoradiation with concurrent temozolomide.
Median overall survival (OS) was 26 months and median time to
progression (TTP) was 14.2 months. Additionally, three patients remain without
relapse more than 4 years from surgery and continue to receive the vaccine
within the clinical trial.
In this single arm Phase 2 study, 22 patients with newly diagnosed and optimally
resected EGFRvIII-positive GBM received CDX-110 in combination with maintenance
temozolomide after having completed chemoradiation with concurrent temozolomide.
Median time to progression (TTP) is 15.2 months and three patients continue
without relapse after more than two years. Results to date from this ongoing study
estimate median overall survival to be 23.6 months (data are not yet final). In
addition, and in line with preclinical data that suggested the
combination with temozolomide could augment immune responses, patients show
robust serological evidence of an immune response against EGFRvIII.
Efficacy data from both ACTIVATE and ACT II compare favorably to data
for a historical control group of 17 patients, matched for EGFRvIII expression,
extent of resection and performance status (Median TTP: 6.3 months; Median OS:
15.0 months). In both studies, CDX-110 was generally well tolerated with local
injection site reactions being the most commonly reported toxicity.
In addition, preliminary data from a pilot study in a small number of
patients with newly diagnosed GBM will be presented. In this study, CDX-110 was given in
combination with daclizumab, an antibody that blocks suppressive T cells, to
determine whether this combination could further augment immune responses. This data will be presented in a poster
session on Sunday, May 31 from 8:00am 12:00pm EDT.
ACT III, a multicenter, single-arm Phase 2 clinical trial in GBM in
which all patients will receive CDX-110 in combination with maintenance temozolomide,
is ongoing. Total enrollment is expected
to be approximately 60 patients. In addition, Pfizer and Celldex are working on
the design of a randomized Phase 2 study in GBM to compare CDX-110 plus
standard of care to standard of care alone.
About CDX-110 (PF-04948568)
CDX-110 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. It is
reported to be present in 25-40 percent of GBM tumors.
About Celldex Therapeutics, Inc.
Celldex Therapeutics is an integrated biopharmaceutical company that
applies its comprehensive Precision Targeted Immunotherapy Platform to generate
a pipeline of candidates to treat cancer and other difficult-to-treat diseases.
Celldex s immunotherapy platform includes a complementary portfolio of
monoclonal antibodies, antibody-targeted vaccines and immunomodulators to create
novel disease-specific drug candidates. For more information, please visit
About Pfizer Oncology
Pfizer Oncology is committed to the discovery, investigation and
development of innovative treatment options for cancer patients worldwide. Our robust pipeline consists of 21 biologics
and small molecules in clinical development across four scientific platforms
anti-angiogenesis, signal transduction, immune-oncology, and cytotoxic
potentiators. Pfizer Oncology has over
200 clinical trials including robust Phase 3 programs in renal cell carcinoma,
prostate cancer, non-small cell lung cancer, metastatic breast cancer,
colorectal cancer, and hepatocellular carcinoma.
By working collaboratively with academic institutions, researchers,
governments, and licensing partners, Pfizer Oncology strives to transform
treatment by targeting the right drug for the right patient at the right time.
For more information, please visit www.Pfizer.com.
Pfizer Inc: Working together for a healthier
Founded in 1849, Pfizer is the world s premier biopharmaceutical company
taking new approaches to better health. We discover, develop, manufacture
and deliver quality, safe and effective prescription medicines to treat and
help prevent disease for both people and animals. We also partner with
healthcare providers, governments and local communities around the world to
expand access to our medicines and to provide better quality health care and
health system support. At Pfizer, more than 80,000 colleagues in more
than 90 countries work every day to help people stay happier and healthier
longer and to reduce the human and economic burden of disease worldwide.
PFIZER DISCLOSURE NOTICE:
The information contained in
this release is as of May 30, 2009. Pfizer assumes no obligation to update
any forward-looking statements contained in this release as the result of new
information or future events or developments.
This release contains forward-looking information about a product
candidate, CDX-110, including its potential benefits, that involves substantial
risks and uncertainties. Such risks and uncertainties include, among other
things, the uncertainties inherent in research and development; decisions by