ImmunoGen, Inc. Announces Trastuzumab Emtansine (T-DM1) Significantly Improved Survival in the EMILIA Phase III Trial
- Trastuzumab emtansine significantly improved overall survival (OS) as well as progression-free survival (PFS) in its lead Phase III trial, EMILIA.
Separately, the marketing application for trastuzumab emtansine has
been submitted to the US FDA, and one is to be submitted shortly to
European Medicines Agency(EMA).
Also reported today was that
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
"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
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 neoadjuvant therapy.
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.
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
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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