ImmunoGen, Inc. Announces Overall Survival Data Reported for Trastuzumab Emtansine (T-DM1) Phase III EMILIA Trial
- Trastuzumab emtansine reduced risk of death by 32% compared to the standard-of-care treatment arm of the trial.
Findings being reported at the ESMO 2012
Congress( European Society of Medical Oncology) and published in New England Journal of Medicine.
The EMILIA trial 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 either with trastuzumab emtansine
— used alone — or with lapatinib (Tykerb®) plus capecitabine (Xeloda®),
standard-of-care in this setting. EMILIA progression-free survival (PFS)
and tolerability findings were previously reported at the
The OS data reported today showed that the risk of death was reduced by 32 percent for patients who received trastuzumab emtansine compared to those who received standard-of-care (hazard ratio=0.68, p=0.0006). Patients treated with trastuzumab emtansine survived a median of 5.8 months longer than those who received Tykerb plus Xeloda: median OS was 30.9 months for patients receiving trastuzumab emtansine versus 25.1 months for patients receiving standard-of-care.
"We're thrilled that trastuzumab emtansine provided this significant
overall survival benefit," commented
The data are being presented today at the ESMO 2012
Other Trastuzumab Emtansine Registration Trials
In HER2-positive breast cancer — Roche has Phase III trials underway evaluating trastuzumab emtansine both for newly diagnosed and for previously treated metastatic disease. It plans to initiate a trial program in early stage disease in 2013, with studies to evaluate the compound for adjuvant use, for neoadjuvant use, and as a treatment for patients with residual invasive disease following standard neoadjuvant therapy.
In HER2-positive gastric cancer — Roche is assessing trastuzumab emtansine for the treatment of advanced, relapsed HER2-positive gastric cancer.
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 proprietary 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.
Trastuzumab emtansine employs ImmunoGen's non-cleavable
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 timing and results. A
review of these risks can be found in ImmunoGen's Annual Report on Form
10-K for the fiscal year ended
Tykerb® is a registered trademark of GlaxoSmithKline plc. Xeloda® is a
registered trademark of Roche. Herceptin® is a registered trademark of
Executive Director, Investor Relations and Corporate Communications
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