Trastuzumab emtansine uses 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.
Genentech has submitted a Biologics License Application (BLA) for trastuzumab emtansine to the US FDA while Roche is expected to submit a Marketing Authorization Application (MAA) to the EMA.
EMILIA has been designed to evaluate trastuzumab emtansine to treat patients with metastatic HER2-positive breast cancer who have in the past been administered trastuzumab (Herceptin) and a taxane.
Patients enrolled in the trial were randomized to treatment with trastuzumab emtansine used alone or with lapatinib (Tykerb)and capecitabine (Xeloda) in combination.
ImmunoGen president and CEO Daniel Junius said that the overall survival endpoint has already been met and had been expected to occur after the submission of the BLA and MAA to the regulatory authorities.
"We developed our TAP technology to achieve more effective, better tolerated anticancer therapies, and are delighted that people treated with trastuzumab emtansine survived significantly longer than those who received a standard therapy," Junius added.