ImmunoGen, Inc. Announces Results from Trastuzumab Emtansine (T-DM1) EMILIA Phase III Trial
WALTHAM, Mass.--(BUSINESS WIRE)--
ImmunoGen,
Inc. (Nasdaq: IMGN), a biotechnology company with a proprietary
Targeted Antibody Payload (TAP) technology, today announced results from
the trastuzumab emtansine Phase III EMILIA trial conducted by Roche.
Trastuzumab emtansine comprises ImmunoGen's DM1 cancer cell-killing
agent linked to the trastuzumab antibody developed by Genentech, a
member of the Roche Group, using ImmunoGen's method of attachment. It is
in global development by Roche under an agreement between ImmunoGen and
Genentech. Roche plans to apply this year for marketing approval of
trastuzumab emtansine in the US and Europe using EMILIA data.
The EMILIA 991-patient trial compares trastuzumab emtansine, used alone,
to lapatinib (Tykerb®) plus capecitabine (Xeloda®) for the treatment of
HER2-positive metastatic breast cancer that has progressed after
treatment with trastuzumab (Herceptin®) and a taxane in any setting
(early or metastatic disease).
Among the study findings reported are:
-
Treatment with trastuzumab emtansine significantly improved
progression-free survival (PFS) compared to treatment with lapatinib
plus capecitabine, as assessed by an independent review committee.
Median PFS was 9.6 months compared to 6.4 months, respectively. The
hazard ratio (HR) was 0.65 (p < 0.0001), meaning that trastuzumab
emtansine reduced the risk of cancer progression or death by 35%
relative to treatment with lapatinib plus capecitabine. PFS is a
co-primary endpoint of EMILIA.
-
Overall survival (OS) is also a co-primary endpoint of EMILIA, and the
OS data are not mature at this time. A sufficient number of events
have occurred to establish median OS for the lapatinib plus
capecitabine treatment group (23.3 months) but not yet for the
trastuzumab emtansine treatment group, and thus longer follow up is
required.
-
For trastuzumab emtansine-treated patients, estimated one-year
survival was 84.7% and estimated two-year survival was 65.4%. For the
patients receiving lapatinib plus capecitabine, estimated one-year and
two-year survival rates were 77.0 % and 47.5%, respectively.
-
Fewer trastuzumab emtansine-treated patients experienced Grade 3 or
higher (severe) adverse events (AEs) than those treated with lapatinib
plus capecitabine (40.8% vs. 57%, respectively). The most common of
these Grade 3 or higher AEs with trastuzumab emtansine were low
platelet count (12.9%), increased enzymes released by the liver/other
organs (4.3% and 2.9%, depending on enzyme type), and anemia (2.7%),
findings consistent with previous studies. The most common Grade 3 or
higher AEs with lapatinib plus capecitabine were diarrhea (20.7%),
hand-foot syndrome (16.4%), vomiting (4.5%), and neutropenia (4.3%).
The EMILIA data have been selected for presentation in a plenary session
of the American Society of Clinical Oncology (ASCO) annual meeting this
afternoon (Abstract #LBA1) and were also featured in the official ASCO
press program.
"These results show that trastuzumab emtansine can make a notable
difference for patients and their families," commented Daniel Junius,
President and CEO. "We developed our TAP technology to achieve markedly
better anticancer therapies and believe these data validate our
approach. We look forward to Roche applying for marketing approval of
trastuzumab emtansine."
In addition to EMILIA, trastuzumab emtansine is in Phase III testing for
treatment of HER2-positive metastatic breast cancer in the MARIANNE and
TH3RESA trials.
About ImmunoGen's Targeted Antibody Payload (TAP) Technology
ImmunoGen developed its TAP technology to achieve more effective, better
tolerated anticancer drugs. A TAP compound consists of a manufactured
antibody that binds specifically to a target found on tumor cells with
one of the Company's highly potent cancer cell-killing agents attached
as a payload using one of ImmunoGen's engineered linkers. The antibody
serves to target the payload specifically to the cancer cells and the
payload serves to kill the cancer cells. In some compounds, the antibody
component also has meaningful anticancer activity.
About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics using the
Company's expertise in tumor biology, monoclonal antibodies, potent
cancer-cell killing agents and engineered linkers. The Company's TAP
technology uses monoclonal antibodies to deliver one of ImmunoGen's
proprietary cancer cell-killing agents specifically to tumor cells.
There are now numerous TAP compounds in clinical development with a
wealth of clinical data reported. ImmunoGen's collaborative partners
include Amgen, Bayer HealthCare, Biotest, Lilly, Novartis, Roche and
Sanofi. The most advanced compound using ImmunoGen's TAP technology,
trastuzumab emtansine (T-DM1), is in Phase III testing through the
Company's collaboration with Genentech, a member of the Roche Group.
More information about ImmunoGen can be found at www.immunogen.com.
This press release includes forward-looking statements. For these
statements, ImmunoGen claims the protection of the safe harbor for
forward-looking statements provided by the Private Securities Litigation
Reform Act of 1995. It should be noted that there are risks and
uncertainties related to the development of novel anticancer products,
including trastuzumab emtansine, including risks related to clinical
studies and regulatory submissions, their timings and results. A review
of these risks can be found in ImmunoGen's Annual Report on Form 10-K
for the fiscal year ended June 30, 2011 and other reports filed with the
Securities and Exchange Commission.
Tykerb® is a registered trademark of GlaxoSmithKline plc.
Xeloda®
is a registered trademark of Roche.
Herceptin® is a registered
trademark of Genentech, a member of the Roche Group.
For Investors:
ImmunoGen, Inc.
Carol Hausner, 781-895-0600
Executive
Director, Investor Relations and Corporate Communications
info@immunogen.com
or
For
Media:
The Yates Network
Barbara Yates, 781-258-6153
Source: ImmunoGen, Inc.
News Provided by Acquire Media
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