This excerpt taken from the AGEN 8-K filed May 7, 2009.
Updated overall survival results from Antigenics’ Phase 3 study of
Oncophage cancer vaccine in nonmetastatic renal cell carcinoma (RCC,
the most common type of kidney cancer) will be presented at the
American Society of Clinical Oncology (ASCO) Annual Meeting in
May/June 2009. The results will be the first set of follow-up survival
data from the patient registry that was initiated after the close of
the Phase 3 study to assess patient outcomes over the long-term.
The updated survival data are expected to support the company’s
Oncophage priorities, namely the ongoing regulatory review of its
marketing application by the European Medicines Agency (EMEA) and
preparation for commercial launch in Russia.
Oncophage was granted orphan drug status for the treatment of glioma
(brain cancer) by the U.S. Food and Drug Administration and EMEA in
April and March, respectively.
In April, a panel of 11 judges assembled at the World Vaccine Congress
recognized Oncophage as the best therapeutic vaccine in the period of
April 2008 through April 2009.
This excerpt taken from the AGEN 8-K filed Feb 19, 2009.
In November 2008, final results from a Phase 1 investigator-sponsored
trial of Oncophage® (vitespen) in recurrent, high-grade glioma were
presented at the Society for Neuro-Oncology’s 13th
Annual Scientific Meeting. All patients enrolled in the trial had at
least one recurrence of brain cancer prior to enrollment and more than
half of the patients had more than one recurrence. The Oncophage
vaccination following brain tumor resection resulted in overall median
survival of approximately 10.5 months, with four patients surviving up
to and beyond 12 months with one patient surviving almost 2.5 years.
This is compared to a historical median survival of only 6.5 months
post surgery. A tumor-specific response was detected after vaccination
in all 12 patients.
The study also observed a correlation between immune response and
overall survival as a result of treatment with Oncophage (n=12; P <
.001). The responses were validated by using three separate immune
techniques and showed that Oncophage evoked a tumor-specific immune
response by producing activated T-cells and natural killer cells that
can potentially destroy tumor cells.
The Phase 2 portion of the investigator-sponsored study of Oncophage
in glioma continues to enroll patients. This study is being supported
by the NIH’s Brain Tumor Specialized Programs of Research Excellence
The European Medicines Agency continues to review the marketing
application for Oncophage as an adjuvant treatment in early-stage
renal cell carcinoma (RCC; the most common type of kidney cancer).
The company continues to make progress toward the commercial launch of
Oncophage in Russia. The current key focus of activities in Russia
pertains to obtaining government reimbursement for Oncophage in 2009.
This excerpt taken from the AGEN 8-K filed Feb 21, 2008.
In May 2007, at the Annual Meeting of the American Urological
Association, Antigenics presented updated results based on its
continued data collection from the Phase 3 trial of Oncophage
(C-100-12) in patients with nonmetastatic renal cell carcinoma (RCC).
These updated results showed that the advantage in the Oncophage arm
persisted or improved in comparison with the first analysis of the
data. In summary, there was an improvement in recurrence-free survival
in the Oncophage arm versus the observation arm of approximately 45
percent (P < 0.01; hazard ratio = 0.55) in the
intermediate-risk patient population (n = 362). A trend toward
improved overall survival (not statistically significant) was also
observed in the intermediate-risk subset.
In the second half of 2007, Antigenics met with urology and oncology
key opinion leaders from Europe, Russia, Canada and the United States
to discuss the updated results from the C-100-12 RCC trial. Overall,
the feedback received was very positive, and has encouraged the
company to explore regulatory pathways for potential filings of
marketing applications in ex-US territories.
In June 2007, a marketing authorization application for Oncophage in
the intermediate-risk patient population was filed in Russia, where
review of the application continues.
Pre-launch activities are ongoing to prepare for potential
commercialization of Oncophage in Russia in mid-2008.
A meeting with the European Medicines Agency (EMEA) is scheduled for
the first quarter of 2008. Antigenics plans to discuss with the EMEA
the potential filing of a marketing authorization application for
conditional authorization of Oncophage.
Antigenics has initiated a survival registry to follow approximately
500 patients from the Phase 3 kidney cancer study. Initial data are
expected by the end of 2008.
Results from a Phase 3 study of Oncophage in metastatic melanoma were
recently published in the Journal of Clinical Oncology. The
published data showed that patients receiving at least 10 doses of
Oncophage had improved median survival of approximately 18.4 months
versus patients who received physician's choice of treatment.
A white paper written by a group of prominent oncologists, including
investigators from Antigenics’ Phase 3 study in kidney cancer and
regulatory experts, was recently published in Cancer (Stebbing et
al.Cancer. 2008 Jan 18. [Epub ahead of print]). The paper
proposes three regulatory mechanisms for accelerated development and
approval of therapeutic cancer vaccines in earlier stages of disease.
A Phase 2 investigator-sponsored study of Oncophage in recurrent
glioma being conducted at the University of California, San Francisco
is ongoing. Updated data from the Phase 1 study showed that 11 out of
12 patients exceeded the historical benchmark of 6.5 months of
survival from time of recurrence. The Phase 1 study also showed that
all 12 treated patients demonstrated a significant and specific immune
response after vaccination with Oncophage (P < 0.001).