ImmunoGen, Inc. Announces Overall Survival Data Reported For Trastuzumab Emtansine (T-DM1) Phase III EMILIA Trial

Date: Oct-02-2012ImmunoGen, Inc. (Nasdaq: IMGN), a biopharmaceutical company that develops anticancer products using its Targeted Antibody Payload (TAP) technology and antibody expertise, have announced the presentation of overall survival (OS) data from the trastuzumab emtansine Phase III trial, EMILIA. Trastuzumab emtansine is in global development by Roche under an agreement between ImmunoGen and Genentech, a member of the Roche Group, and utilizes ImmunoGen's TAP technology with the trastuzumab antibody. Genentech and Roche have applied for marketing approval of trastuzumab emtansine in the US and Europe, respectively.

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 American Society of Clinical Oncology (ASCO) annual meeting in June 2012: patients treated with trastuzumab emtansine had a significant improvement in PFS (hazard ratio=0.65, phttp://www.nejm.org).

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 SMCC linker and DM1 cancer-killing agent.

View drug information on Herceptin; Tykerb; Xeloda.
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