ImmunoGen, Inc. Announces Positive Results in Trastuzumab Emtansine (T-DM1) EMILIA Phase III Trial
March 30 2012 - 12:01AM
Business Wire
ImmunoGen, Inc. (Nasdaq: IMGN), a
biotechnology company that develops anticancer products using its
Targeted Antibody Payload (TAP) technology, today announced that
Roche has announced positive topline results from its trastuzumab
emtansine (T-DM1) EMILIA Phase III trial. Trastuzumab emtansine
consists of ImmunoGen's potent cancer-killing agent, DM1, attached
to the HER2-targeting antibody, trastuzumab, and is in global
development by Roche under an agreement between ImmunoGen and
Genentech, a member of the Roche Group.
Roche announced today that the EMILIA patients who were
randomized to treatment with trastuzumab emtansine had a
significantly longer duration of progression-free survival (PFS)
than those randomized to treatment with the control therapy,
lapatinib (Tykerb®) plus capecitabine (Xeloda®). EMILIA is the most
advanced trastuzumab emtansine Phase III study, and evaluates the
compound for the treatment of HER2-positive metastatic breast
cancer (mBC) in patients who have previously received treatment
with trastuzumab (Herceptin®) and a taxane.
Roche said that, based on these findings, it plans to apply for
marketing approval of trastuzumab emtansine for HER2-positive mBC
in the US (through Genentech) and in Europe. Roche also noted that
the safety profile of trastuzumab emtansine in the EMILIA trial was
consistent with previous studies and that final results for overall
survival (OS) are not yet mature. PFS and overall survival are
co-primary efficacy endpoints of EMILIA.
“The topline results reported today underscore the significance
of trastuzumab emtansine and its potential to help patients,”
commented Daniel Junius, President and CEO. “We’re delighted with
these results and with Roche’s plans to submit trastuzumab
emtansine for marketing approval. We look forward to seeing the
detailed study data at an upcoming medical meeting.”
Trastuzumab emtansine is in Phase III testing for treatment of
HER2-positive mBC in multiple clinical settings in the EMILIA,
MARIANNE, and TH3RESA trials, and in Phase II testing for
adjuvant/neoadjuvant use for earlier-stage disease.
Conference Call Information
ImmunoGen is holding a conference call today at 8:00 am ET to
discuss this release and also the Company’s advancement of its
wholly owned IMGN901 product candidate into Phase II testing. To
access the live call by phone, dial 913-312-0982. Passcode is
8250254. The call also may be accessed through the Investor
Information section of the Company's website, www.immunogen.com.
Following the live webcast, a replay of the call will be available
at the same location through April 6, 2012.
About ImmunoGen’s 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-killing agents attached as a payload. The antibody serves to
target the payload specifically to the cancer cells, and the
payload serves to kill the cancer cells. In the case of some
compounds that use ImmunoGen’s TAP technology (trastuzumab
emtansine and ImmunoGen’s IMGN529 compound), 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-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, 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 (T-DM1),
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.
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