Positive Phase III data for T-DM1 (Genentech/Roche) Breast Cancer patients

The Phase III EMILIA study of T-DM1 (trastuzumab emtansine), from Genentech / Roche, met its co-primary endpoint of a significant improvement in the time people with HER2-positive metastatic Breast Cancer lived without their disease getting worse. The study showed that the risk of disease worsening or death was reduced by 35 percent for people who received T-DM1 compared to those who received lapatinib plus Xeloda (capecitabine) chemotherapy. The EMILIA study is the first randomized Phase III trial of T-DM1 in people with HER2-positive Breast Cancer who had previously received Herceptin (trastuzumab) and a taxane chemotherapy. There was also a trend for people who received T-DM1 to live longer than those who received lapatinib plus Xeloda, but data are not complete - median progression free survival was 9.6 months compared to 6.4 months, respectively. Two-year survival was 65.4 percent compared to 47.5 percent, respectively. The drug's safety profile was consistent with that in previous studies. The data will be presented at the Annual Meeting of the American Society of Clinical Oncology by Kim Blackwell, Duke University School of Medicine. Based on the EMILIA findings, Genentech / Roche plan to submit applications for HER2-positive Breast Cancer to the FDA and EMA in 2012.