Immunogen’s (NASDAQ: IMGN) partner, Roche Holdings (OTC:RHHBY), reported new data from a Phase III trial, demonstrating that trastuzumab emtansine (T-DM1), which leverages technology from IMGN, significantly improved survival of people with HER2-positive metastatic breast cancer (mBC). The trial, known as the EMILIA study, met its primary efficacy endpoint of overall survival (OS). Results showed that T-DM1 significantly extended the lives of people with HER2-positive mBC vs. combination treatment with lapatinib and Xeloda (capecitabine). EMILIA enrolled patients with HER2-positive mBC that had previously received Herceptin (trastuzumab) and taxane chemotherapy, and given this morning’s results, the study has now met both co-primary efficacy endpoints: significant improvements in overall survival and progression-free survival (PFS). Roche has filed for FDA approval, and has stated that it will submit an application in Europe in the near-future. Data from EMILIA are anticipated to be presented at an upcoming medical meeting. IMGN shares are up 15.6% in pre-market trading and are likely to be strong throughout the day, as the read-through on today’s results is that approval is a near-certainty. Analysts expect TDM-1 to be approved in the U.S. in early 2013, assuming a Priority Review.