(Nasdaq: IMGN), a biotechnology company with a proprietary Targeted Antibody Payload (TAP) technology, today announced that Roche is implementing a “three-pronged approach” to developing trastuzumab emtansine (T-DM1) for early stage HER2-positive breast cancer, according to plans outlined by Roche at its 2012 ASCO analyst event. Trastuzumab emtansine uses ImmunoGen’s TAP technology with Roche’s trastuzumab antibody and is in global development by Roche under an agreement between ImmunoGen and Genentech, a member of the Roche Group.
In its analyst event presentation, Roche reported that it intends to initiate three studies with trastuzumab emtansine for early stage HER2-positive breast cancer, assessing the compound:
- As single-agent therapy for patients with residual invasive disease following preoperative (neoadjuvant) systemic treatment;
- Used in combination with chemotherapy and pertuzumab in the adjuvant setting; and
- Used in combination with chemotherapy and pertuzumab in the neoadjuvant setting.
Roche expects to begin all three trials in 2013. Additional details on the plans reported are available on Roche’s website,
“Genentech and Roche have unparalleled experience in the development of HER2-targeting antibody therapies for breast cancer,” commented Daniel Junius, President and CEO. “With the studies outlined today, their plans for trastuzumab emtansine now include registration studies across the spectrum of early stage to advanced HER2-positive breast cancer.”
Trastuzumab emtansine is currently being evaluated in three Phase III trials for the treatment of HER2-positive metastatic breast cancer. Data from the first of these, EMILIA, were reported in a plenary session at ASCO earlier today and, per Roche, will form the basis of its applying for marketing approval of the compound in the US and Europe.
Trastuzumab emtansine comprises ImmunoGen's DM1 cancer cell-killing agent linked using the Company’s method of attachment to the trastuzumab antibody developed by Genentech.