Trastuzumab emtansine significantly improved overall survival (OS) as
well as progression-free survival (PFS) in its lead Phase III trial,
Separately, the marketing application for trastuzumab emtansine has
been submitted to the US FDA, and one is to be submitted shortly to
the European Medicines Agency (EMA).
WALTHAM, Mass.--(BUSINESS WIRE)--
Inc. (Nasdaq: IMGN), a biotechnology company that develops
anticancer products using its Targeted Antibody Payload (TAP) technology
and antibody expertise, today announced that Roche has reported that
updated results from its EMILIA Phase III trial show that patients
treated with trastuzumab emtansine had a significant improvement in OS
compared to those randomized to standard-of-care therapy. Trastuzumab
emtansine utilizes ImmunoGen's TAP technology with the trastuzumab
antibody and is in global development by Roche under an agreement
between ImmunoGen and Genentech, a member of the Roche Group.
Also reported today was that Genentech has submitted a Biologics License
Application (BLA) for trastuzumab emtansine to the US FDA, and that
Roche expects to soon submit a Marketing Authorization Application (MAA)
to the EMA.
EMILIA was designed to evaluate trastuzumab emtansine for the treatment
of patients with metastatic HER2-positive breast cancer who have
previously received trastuzumab (Herceptin®) and a taxane. Patients
enrolled were randomized to treatment with trastuzumab emtansine — used
alone — or with lapatinib (Tykerb®) plus capecitabine (Xeloda®),
standard-of-care in this setting.
The first EMILIA results were reported at the American Society of
Clinical Oncology (ASCO) annual meeting in June 2012, and included that
trastuzumab emtansine significantly improved PFS compared to
standard-of-care therapy and that fewer of the trastuzumab
emtansine-treated patients experienced Grade 3 or higher (severe)
adverse events.1 A previous interim analysis of OS
demonstrated a trend towards improved OS in the trastuzumab
emtansine-treated patients. The updated results reported today will be
presented at an upcoming medical meeting.
"It's impressive that the overall survival endpoint has already been met
— this had been expected to occur well after the submission of the BLA
and MAA to the regulatory authorities," commented Daniel Junius,
President and CEO. "We developed our TAP technology to achieve more
effective, better tolerated anticancer therapies, and are delighted that
people treated with trastuzumab emtansine survived significantly longer
than those who received a standard therapy."
Roche has Phase III trials underway evaluating trastuzumab emtansine
both for newly diagnosed and for previously treated metastatic
HER2-positive breast cancer. Additionally, it plans to initiate
registration trials beginning in 2013 to evaluate the compound for three
settings in earlier-stage disease: adjuvant use; neoadjuvant use; and
treatment of patients with residual invasive disease following standard
About ImmunoGen's TAP Technology
A TAP compound consists of a monoclonal, or 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 ten TAP compounds in clinical development, of which three are wholly
owned by the Company. A marketing application for trastuzumab emtansine
(T-DM1), the most advanced compound using ImmunoGen's TAP technology,
has been submitted in the US. Roche is developing this compound globally
under an agreement between ImmunoGen and 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.
1ASCO June 2012 (abstract #LBA1).
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.
Carol Hausner, 781-895-0600
Director, Investor Relations and Corporate Communications
The Yates Network
Barbara Yates, 781-258-6153
Source: ImmunoGen, Inc.
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