SOUTH SAN FRANCISCO (dpa-AFX) - ImmunoGen Inc. (IMGN) said that Roche has reported that updated results from its EMILIA Phase III study demonstrate that patients treated with trastuzumab emtansine or T-DM1 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.
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 or EMA. EMILIA was designed to evaluate trastuzumab emtansine for the treatment of patients with metastatic HER2-positive breast cancer who have previously received trastuzumab and a taxane.
Roche has Phase III studies underway evaluating trastuzumab emtansine both for newly diagnosed and for previously treated metastatic HER2-positive breast cancer. Further, it intends 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.
Copyright RTT News/dpa-AFX