Positive results from Genentech's T-DM1 Phase III trial on HER2-positive mBC

ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops anticancer products using its Targeted Antibody Payload (TAP) technology, today announced that Roche has announced positive topline results from its trastuzumab emtansine (T-DM1) EMILIA Phase III trial. Trastuzumab emtansine consists of ImmunoGen's potent cancer-killing agent, DM1, attached to the HER2-targeting antibody, trastuzumab, and is in global development by Roche under an agreement between ImmunoGen and Genentech, a member of the Roche Group.    

Roche announced today that the EMILIA patients who were randomized to treatment with trastuzumab emtansine had a significantly longer duration of progression-free survival (PFS) than those randomized to treatment with the control therapy, lapatinib (Tykerb®) plus capecitabine (Xeloda®). EMILIA is the most advanced trastuzumab emtansine Phase III study, and evaluates the compound for the treatment of HER2-positive metastatic breast cancer (mBC) in patients who have previously received treatment with trastuzumab (Herceptin®) and a taxane.

Roche said that, based on these findings, it plans to apply for marketing approval of trastuzumab emtansine for HER2-positive mBC in the US (through Genentech) and in Europe. Roche also noted that the safety profile of trastuzumab emtansine in the EMILIA trial was consistent with previous studies and that final results for overall survival (OS) are not yet mature. PFS and overall survival are co-primary efficacy endpoints of EMILIA.

"The topline results reported today underscore the significance of trastuzumab emtansine and its potential to help patients," commented Daniel Junius, President and CEO. "We're delighted with these results and with Roche's plans to submit trastuzumab emtansine for marketing approval. We look forward to seeing the detailed study data at an upcoming medical meeting."

Trastuzumab emtansine is in Phase III testing for treatment of HER2-positive mBC in multiple clinical settings in the EMILIA, MARIANNE, and TH3RESA trials, and in Phase II testing for adjuvant/neoadjuvant use for earlier-stage disease.