Agenus Inc. (NASDAQ: AGEN) today announced that a recent analysis from a
Phase 2 trial in patients with newly diagnosed glioblastoma multiforme
(GBM) treated with Prophage Series G-100 (HSPPC-96) in combination with
the current standard of care (radiation and temozolomide) showed an
almost 18 month median progression free survival (PFS), which represents
a 160% increase versus current standard of care alone. This analysis
confirms continuation of the positive trends from the Phase 2 HSPPC-96
newly diagnosed GBM trial first reported at the 81st American
Association of Neurological Surgeons (AANS) Annual Scientific Meeting in
May 2013.
“These additional results from the Phase 2 trial of HSPPC-96 in patients
with newly diagnosed GBM are extremely encouraging and certainly justify
a definitive randomized study,” said Andrew T. Parsa, MD, PhD, Lead
Clinical Investigator and Chair of Neurosurgery at Northwestern Memorial
Hospital and Northwestern University Feinberg School of Medicine. “The
patient-specificity and lack of toxicity, combined with patient
selection to optimize immunotherapy efficacy, could position this
vaccine as a break-through treatment for newly diagnosed GBM patients in
the years ahead.”
Based on these findings, Agenus plans to hold an end of Phase 2 meeting
with the US Food and Drug Administration to discuss a Phase 3 trial that
could potentially lead to marketing approval of the HSPPC-96 vaccine as
a treatment for patients with newly diagnosed GBM.
Phase 2 HSPPC-96 Update in Newly Diagnosed GBM Patients
The Phase 2 trial of HSPPC-96 in patients with newly diagnosed GBM
includes 46 patients treated at eight centers across the US. Patients
were treated with radiation and temozolomide as the standard of care in
addition to HSPPC-96 vaccination. Analyses of data collected to date
show a median PFS of 17.8 months with 63% of the patients progression
free at twelve months and 20% progression free at 24 months. These
results indicate considerable improvement when compared to patients
treated with the standard of care (radiation plus temozolomide), which
is 6.9 months.1
Median overall survival (OS), the primary endpoint of the trial, is 23.3
months and remains durable in patients treated with HSPPC-96. In this
study, the 12 month survival rate is 85% with 50% of patients still
alive and being followed, with many surviving beyond the 24 month study
period. For the standard of care alone, median OS survival rate is 14.6
months.1
The Phase 2 recurrent and newly diagnosed trials are being sponsored by
Dr. Parsa and are primarily supported through funding from the American
Brain Tumor Association, Accelerated Brain Cancer Cure, National Brain
Tumor Society, and National Cancer Institute Special Programs of
Research Excellence. Dr. Parsa has not received any financial support or
expense reimbursement for this work or for consulting activities on
behalf of Agenus. He does not have an equity interest in Agenus or a
financial relationship with the company.
About the Randomized HSPPC-96 ALLIANCE Trial in Recurrent GBM
In addition to the Phase 2 newly diagnosed GBM trial, the Cancer Therapy
Evaluation Program (CTEP) of the National Cancer Institute (NCI) is
supporting a study of the HSPPC-96 vaccine in a large, randomized Phase
2 trial in combination with bevacizumab (Avastin®) in
patients with surgically resectable recurrent GBM. Patients have already
been randomized into this trial and active recruitment is underway at
multiple centers in the US. The study is being sponsored by the Alliance
for Clinical Trials in Oncology (ALLIANCE), a cooperative group of the
NCI. This trial is the largest brain tumor trial ever funded by the NCI
and the largest vaccine study ever conducted with Avastin.
The ALLIANCE trial is investigating the potential benefits of treatment
with a combination of HSPPC-96 and bevacizumab in a three-arm study of
approximately 222 patients with surgically resectable recurrent GBM
using a primary endpoint of overall survival. The study will compare
efficacy of the HSPPC-96 vaccine administered with bevacizumab either
concomitantly or at progression, versus treatment with bevacizumab
alone. This study design is supported in part by previous research
indicating a potential synergistic effect between the mechanisms of
action behind both HSPPC-96 and bevacizumab. For additional information
about the ALLIANCE trial visit ClinicalTrials.gov using Identifier
NCT01814813.
The ALLIANCE is composed of three NCI funded cooperative groups
(American College of Surgeons Oncology Group [ACOSOG], Cancer and
Leukemia Group B [CALGB], and North Central Cancer Treatment Group
[NCCTG]). These three groups have been integrated in an effort to
develop and conduct more efficient clinical research studies to bring
clinical trial results to patients more quickly.
In addition to the newly diagnosed GBM study in Prophage Series G-100
and the ALLIANCE trial, a Phase 2 study testing the Prophage Series
G-200 in patients with recurrent glioma has been completed. Agenus
expects the final trial results of this study to be published in a
scientific journal in 2014.
About Glioblastoma Multiforme (GBM)
The incidence rates of primary malignant brain and central nervous
system cancers have increased over the last three decades.2
The American Cancer Society estimates that more than 23,000 malignant
tumors of the brain or spinal cord will be diagnosed during 2013 in the
US, and that more than 14,000 people will die from these tumors. 3
GBM is the most common primary malignant brain tumor and accounts for
the majority of diagnoses. It has been associated with a particularly
poor prognosis, with survival rates at one and five years equaling 33.7%
and 4.5%, respectively.4 The current standard of care for
patients with newly diagnosed GBM is surgical resection followed by
fractionated external beam radiotherapy and systemic temozolomide5
resulting in a median OS of 14.6 months6 based on data from a
randomized Phase 3 trial. Although this treatment can prolong survival,
it is not curative and the vast majority of patients with GBM experience
recurrent disease, with a median time to recurrence of seven months.7
Currently, there is no standard treatment for patients with recurrent
GBM, although additional surgery, chemotherapy (i.e., CCNU,
temozolomide), bevacizumab, and radiotherapy are used.
About the Prophage Series (HSPPC-96) Cancer Vaccines
Prophage Series cancer vaccines are autologous therapies derived from
cells extracted from the patient’s tumor. As a result, Prophage Series
vaccines contain a precise antigenic ‘fingerprint’ of a patient’s
particular cancer and are designed to reprogram the body’s immune system
to target only cells bearing this fingerprint, reducing the risk that
powerful anti-cancer agents will target healthy tissue and cause
debilitating side effects often associated with chemotherapy and
radiation therapy. The Prophage Series G vaccines are currently being
studied in two different settings of glioblastoma: newly diagnosed and
recurrent disease.
About Agenus
Agenus Inc. is a biotechnology company working to develop treatments for
cancers and infectious diseases. The company is focused on
immunotherapeutic products based on strong platform technologies with
multiple product candidates advancing through the clinic, including
several product candidates that have advanced into late-stage clinical
trials through corporate partners. Between Agenus and its partners, 23
programs are in clinical development. For more information, please visit www.agenusbio.com,
or connect with the company on Facebook,
LinkedIn,
Twitter
and Google+.
Forward-Looking Statement
This press release contains forward-looking statements, including
statements regarding clinical trial activities, the publication of data,
and the potential application of the Company’s technologies and product
candidates in the prevention and treatment of diseases. These
forward-looking statements are subject to risks and uncertainties that
could cause actual results to differ materially. These risks and
uncertainties include, among others, the factors described under the
Risk Factors section of our Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission for the period ended June 30, 2013.
Agenus cautions investors not to place considerable reliance on the
forward-looking statements contained in this release. These statements
speak only as of the date of this document, and Agenus undertakes no
obligation to update or revise the statements. All forward-looking
statements are expressly qualified in their entirety by this cautionary
statement. Agenus’ business is subject to substantial risks and
uncertainties, including those identified above. When evaluating Agenus’
business and securities, investors should give careful consideration to
these risks and uncertainties.
References
1. Stupp, R., et al., Radiotherapy plus concomitant and adjuvant
temozolomide for glioblastoma. N
Engl J Med, 2005. 352(10): p. 987-96.
2. Maher EA, McKee AC. In: Atlas of diagnostic oncology. 3. Skarin AT,
Canellos GP, editor. London: Elsevier Science; 2003. Neoplasms of the
central nervous system; pp. 5–10.
3. http://www.cancer.gov/cancertopics/pdq/treatment/adultbrain/HealthProfessional/page1
4. Central Brain Tumor Registry of the United States (CBTRUS) 2010
CBTRUS statistical report: primary brain and central nervous system
tumors diagnosed in the United States in 2004-2006. http://www.cbtrus.org/reports/reports.html
5. National Comprehensive Cancer Network clinical practice guidelines in
oncology-central nervous system cancers. v.1.2010.
6. Stupp, R., et al., Radiotherapy plus concomitant and adjuvant
temozolomide for glioblastoma. N
Engl J Med, 2005. 352(10): p. 987-96.
7. Wen PY, DeAngelis LM. Chemotherapy for low-grade gliomas: emerging
consensus on its benefits. Neurology. 2007;68(21):1762–1763. doi:
10.1212/01.wnl.0000266866.13748.a9.
Avastin is a registered trademark of Genentech.
Copyright Business Wire 2013