T-DM1 Significantly Improved Progression-Free Survival in Randomized Phase II Trial
WALTHAM, Mass.--(BUSINESS WIRE)--Apr 7, 2011 - ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops targeted antibody-based anticancer products, today announced that Roche has disclosed positive top-line results from the first randomized trial assessing trastuzumab emtansine (T-DM1, previously known as trastuzumab-DM1) in HER2-positive metastatic breast cancer (MBC). T-DM1 consists of ImmunoGen's DM1 cancer cell-killing agent attached using the Company's linker to the HER2-targeting antibody, trastuzumab, developed by Genentech, a member of the Roche Group.
The top-line results disclosed by Roche in a press release today were that patients treated with T-DM1 had a significant improvement in progression-free survival compared with patients treated with Herceptin® (trastuzumab) plus chemotherapy (docetaxel) in the Phase II trial comparing these agents for first-line treatment for HER2-positive MBC.
The detailed findings from this randomized, 137-patient trial are being submitted for presentation at a future medical conference. Favorable preliminary data were reported previously from this trial at the 35th Congress of the European Society of Medical Oncology (ESMO), but progression-free survival data were not available at that time.1
“This top-line information about T-DM1's performance in the first-line setting is very encouraging and adds to the favorable efficacy and safety data reported across a number of T-DM1 studies. We look forward to learning the detailed data when they are reported at a medical conference,” said Daniel Junius, President and CEO.
About Trastuzumab Emtansine (T-DM1)
Trastuzumab emtansine (the generic or International Non-proprietary Name for T-DM1) utilizes ImmunoGen's Targeted Antibody Payload (TAP) technology with the trastuzumab antibody developed by Genentech. The compound is in global development by Roche under a collaboration agreement between ImmunoGen and Genentech.
T-DM1 is in Phase III testing for second-line and first-line treatment of HER2-positive MBC. A Phase II trial evaluating the safety of T-DM1 in the neoadjuvant/adjuvant setting began in late 2010.
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-cell killing agents specifically to tumor cells. There are currently seven TAP compounds in the clinic, with a wealth of clinical data reported with the technology. ImmunoGen's collaborative partners include Amgen, Bayer Schering Pharma, Biogen Idec, Biotest, Genentech (a member of the Roche Group), Novartis, and sanofi-aventis. The most advanced compound using ImmunoGen's TAP technology, trastuzumab emtansine (T-DM1), is in Phase III testing through the Company's collaboration with Genentech. More information about ImmunoGen can be found at www.immunogen.com.
1 Perez E. et al., ESMO 2010, Abstract LBA3
Herceptin® is a registered trademark of Genentech.
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 uncertainties around clinical studies and data acceptance for presentation, as well as 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, 2010 and other reports filed with the Securities and Exchange Commission.
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Posted: April 2011