Genentech reports successful EMILIA study results for T-DMI for HER-2 Breast Cancer

Topline results of EMILIA, the first randomized Phase III study of T-DM1 (trastuzumab emtansine) are announced by Genentech. The study enrolled people with HER2-positive metastatic Breast Cancer (mBC) who had previously received treatment with Herceptin (trastuzumab) and a taxane chemotherapy. The study showed people who received trastuzumab emtansine lived significantly longer without their disease getting worse (progression-free survival, or PFS) compared to those who received lapatinib plus Xeloda (capecitabine). Final results for overall survival , a co-primary efficacy endpoint of EMILIA, are not yet mature. The safety profile of trastuzumab emtansine was consistent with that seen in previous studies. These data will be submitted for presentation at an upcoming medical meeting.Trastuzumab emtansine is an investigational medicine known as an antibody-drug conjugate (ADC). It is comprised of the antibody trastuzumab and the chemotherapy DM1 attached together using a stable linker. It is designed to target and inhibit HER2 signaling and deliver the chemotherapy directly inside HER2-positive cancer cells. Genentech plans to submit a Biologics License Application for trastuzumab emtansine to the FDA this year for HER2-positive mBC. In addition, Roche plans to submit a Marketing Authorization Application to the EMA this year for the same indication.