Genentech’s T-DM1 Phase III study on HER2-positive mBC meets primary endpoint

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III EMILIA study of trastuzumab emtansine (T-DM1) met its co-primary endpoint of a significant improvement in the time people with HER2-positive metastatic breast cancer (mBC) lived without their disease getting worse (progression-free survival, PFS). The study showed that the risk of disease worsening or death was reduced by 35 percent for people who received trastuzumab emtansine compared to those who received lapatinib plus Xeloda^® (capecitabine) chemotherapy>® (trastuzumab) and a taxane chemotherapy.    

There was also a trend for people who received trastuzumab emtansine to live longer (overall survival or OS, the other co-primary endpoint of the study) than those who received lapatinib plus Xeloda, but these data are currently not mature. The safety profile of trastuzumab emtansine was consistent with that seen in previous studies, with fewer people who received trastuzumab emtansine experiencing Grade 3 or higher (severe) adverse events (AEs) than those who received lapatinib plus Xeloda (40.8 percent compared to 57.0 percent).

The EMILIA data will be presented in the plenary session at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago by Kim Blackwell, M.D., Duke University School of Medicine (Abstract LBA1, Sunday, June 3, 1:45 p.m. CDT). The EMILIA data were also featured in the official ASCO press program on Saturday, June 2.

"The encouraging efficacy, safety profile and quality of life results from the EMILIA study support our belief that trastuzumab emtansine may have an important role for patients with HER2-positive metastatic breast cancer," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "We are working with global regulatory authorities to submit these data as quickly as possible and hope that trastuzumab emtansine will soon be available to patients with this aggressive type of breast cancer."

Based on the EMILIA findings, Genentech and Roche plan to submit applications for trastuzumab emtansine in HER2-positive mBC this year to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).