(ChemotherapyAdvisor) – New data from the phase 3 EMILIA study demonstrated that trastuzumab emtansine (T-DM1) significantly improves survival in patients with human estrogen receptor 2 (HER2)-positive metastatic breast cancer, according to a press release issued by Genentech, Inc., a member of the Roche Group, on August 26.
The EMILIA study is a randomized, open label study that evaluated the efficacy of T-DM1 compared to the combination of lapatinib and capecitabine in 991 patients with HER2-positive metastatic breast cancer who had previously been treated with trastuzumab and a taxane-based chemotherapy. The new data show that the trial has now met both co-primary efficacy end points: overall survival and progression-free survival (PFS).
Results from the EMILIA study, presented 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO), were previously reported by ChemotherapyAdvisor. However, the new data provide updated overall survival results.
“This confirmatory analysis of overall survival in the Phase III EMILIA study crossed the pre-specified boundary that showed trastuzumab emtansine significantly extended the lives of people with HER2-positive mBC compared to the combination of lapatinib and Xeloda,” Genentech stated in their recent press release.
“Based on these updated overall survival results, people in the lapatinib and Xeloda arm of EMILIA will be offered the option to receive trastuzumab emtansine. In addition, Genentech plans to open an Expanded Access Program (EAP) in the United States to provide, under certain circumstances, people with HER2-positive mBC access to trastuzumab emtansine while the company seeks regulatory approval.”