Full Press Release Details
MAGE-A3 Cancer Immunotherapeutic Phase 3 Study in Non-Small Cell Lung
Cancer Misses First Co-Primary Endpoints
continue study until third co-primary endpoint is assessed
LEXINGTON, Mass.--(BUSINESS WIRE)--March 20, 2014--Agenus Inc. (Nasdaq:
AGEN) today announced that GlaxoSmithKline's (NYSE: GSK) MAGRITi
study, a Phase 3 randomized, blinded, placebo-controlled MAGE-A3ii
cancer immunotherapeutic trial in non-small cell lung cancer patients,
which contains Agenus'QS-21 Stimulon adjuvant,
did not meet its first or second co-primary endpoint. The study did not
significantly extend the disease-free survival (DFS)iii
period when compared to placebo in the overall MAGE-A3 positive patients
or patients who did not receive chemotherapy.
GSK announced that it will continue the study until an analysis of the
third co-primary endpoint is complete. The third co-primary endpoint is
based on predefined criterion that was discussed with regulatory
authorities. This analysis is based on gene signature and designed to
prospectively identify MAGE-A3 positive patients who may benefit more
from treatment. If further analysis shows that the predefined gene
signature subset data are successful, there is the potential for
regulatory filing. GSK anticipates that these data should be available
in 2015. Until then, GSK will remain blinded to all safety and efficacy
The Independent Data Monitoring Committee for the MAGRIT study indicated
that a review of the safety information raised no specific concern for
the continuation of the trial.
About GSK's MAGRIT Program
In this study, patients were given up to 13 intramuscular injections of
either the MAGE-A3 immunotherapeutic or placebo over a period of 27
GSK currently remains blinded to further details of the analysis of the
first two co-primary endpoints in order to allow for the unbiased
generation of a mathematical model to assess the third co-primary
endpointiv, which is expected to be known in 2015. GSK is
also continuing to evaluate whether a gene signature can identify a
population that would benefit from the same investigational MAGE-A3
cancer immunotherapeutic in DERMA, another Phase 3 trial in melanoma,
which reported on the first co-primary endpoint in September 2013.
For additional information, please visit GSK's website at www.gsk.com.
Agenus is a biopharmaceutical company developing a portfolio of
immuno-oncology candidates, including checkpoint modulators (CPMs), heat
shock protein vaccines and adjuvants. The company's proprietary
discovery engine Retrocyte Display is designed to
rapidly generate high quality therapeutic antibody drug candidates using
a high-throughput approach incorporating full-length IgG format human
antibody libraries expressed in mammalian B-lineage cells. A portfolio
of checkpoint modulator programs is advancing in preclinical
development. The company's heat shock protein vaccines for cancer and
infectious disease are in Phase 2 studies. Agenus' QS-21 Stimulon
adjuvant platform is extensively partnered with GlaxoSmithKline and
Janssen and includes several candidates in Phase 3 trials. Among 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+.
i A double-blind, randomised, placebo-controlled Phase III trial to
assess the efficacy of recMAGE-A3 + AS15 antigen-specific cancer
immunotherapeutic as adjuvant therapy in patients with MAGE-A3 positive
NSCLC (MAGRIT, NCT00480025).
ii MAGE-A3 cancer immunotherapeutic consists of recombinant MAGE-A3
protein and a novel immunostimulant AS15 (a combination of QS-21 Stimulon
adjuvant, monophosphoryl lipid A, and CpG7909, a TLR-9 agonist, in a
liposomal formulation).
iii DFS is defined as the time from randomization to the date of first
recurrence of the disease or death, whichever comes first.
iv Access to a proportion of the data (the training set) will allow for
the unbiased generation of a mathematical model to assess the third
co-primary endpoint in the remainder of the data (the test set).
Stimulon and Retrocyte Display are registered trademarks of Agenus Inc.
and its subsidiaries.
Forward-Looking Statement
This press release contains forward-looking statements, including
statements regarding the Company's and/or its licensees' clinical trial
activities, the publication of data, and the potential application of
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 Annual Report on Form
10-K filed with the Securities and Exchange Commission for the year
ended December 31, 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.
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