Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced updated survival results from the Phase III EMILIA study, which showed that people with previously treated HER2-positive metastatic breast cancer (mBC) survived significantly longer (overall survival, a co-primary endpoint) when treated with trastuzumab emtansine (T-DM1) compared to those who received the combination of lapatinib and Xeloda ® (capecitabine). Results showed the risk of death was reduced by 32 percent for people who received trastuzumab emtansine compared to those who received lapatinib plus Xeloda (HR=0.68, p=0.0006). People in the study treated with trastuzumab emtansine survived a median of 5.8 months longer than those who received lapatinib and Xeloda (median overall survival: 30.9 months vs. 25.1 months). No new safety signals were observed and adverse events (AEs) were consistent with those seen in previous studies, with fewer people who received trastuzumab emtansine experiencing Grade 3 or higher (severe) AEs than those who received lapatinib plus Xeloda (40.8 percent vs. 57.0 percent).
"We are extremely pleased that the new data from the EMILIA study showed people receiving trastuzumab emtansine survived longer than those who received the standard of care," said Hal Barron, M.D., chief medical officer and head, Global Product Development. “We are continuing to work with regulatory authorities to bring this innovative medicine, which significantly improved both progression-free survival and overall survival, to people with HER2-positive metastatic breast cancer as soon as possible.”
These updated survival results from the EMILIA study will be presented at the ESMO 2012 Congress (European Society for Medical Oncology) (Abstract #LBA12, Monday, October 1, 2012, 2:10pm CEST) by Dr. Sunil Verma, Sunnybrook Regional Cancer Center, University of Toronto, Canada. Data from the EMILIA study has also been published today in the online edition of the New England Journal of Medicine.
Genentech has submitted a Biologics License Application (BLA) for trastuzumab emtansine to the U.S. Food and Drug Administration (FDA) for use in people with HER2-positive, unresectable locally advanced or metastatic breast cancer who have received prior treatment with Herceptin and a taxane chemotherapy. Roche has submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for the same indication.