EMILIA Study: T-DM1 Significantly Improves Overall Survival in HER2-positive Metastatic Breast Cancer

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Updated results from the phase III EMILIA study showed that trastuzumab emtansine (T-DM1) significantly improved overall survival of people with HER2-positive metastatic breast cancer compared to the combination of lapatinib and capecitabine (Xeloda).

The new data were reported in a press release issued by Genentech on August 26, 2012.

Primary Endpoints Met

The EMILIA study in patients with HER2-positive metastatic breast cancer who had previously received trastuzumab (Herceptin) and taxane chemotherapy has now met both coprimary efficacy endpoints of significant improvements in overall survival and progression-free survival. These data will be presented at an upcoming medical meeting, according to the press release.

Based on these updated overall survival results, people in the lapatinib and capecitabine arm of EMILIA will be offered the option to receive trastuzumab emtansine.

Trastuzumab emtansine is an antibody-drug conjugate being studied in HER2-positive cancers. It is comprised of the antibody trastuzumab and the chemotherapy DM1 attached together using a stable linker. Trastuzumab emtansine is designed to target and inhibit HER2 signaling and deliver the chemotherapy DM1 directly inside HER2-positive cancer cells.

Previously Presented EMILIA Results

A previous interim analysis of overall survival demonstrated a trend towards improved overall survival in people receiving trastuzumab emtansine compared to those who received lapatinib plus capecitabine. However, the data were not considered statistically significant at that time. ■




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