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New Data From Phase III EMILIA Study Showed Genentech’s Trastuzumab Emtansine (T-DM1) Significantly Improved Survival Of People With HER2-Positive Metastatic Breast Cancer

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced updated results from the Phase III EMILIA study, which showed that trastuzumab emtansine (T-DM1) significantly extended the lives (improved overall survival) of people with HER2-positive metastatic breast cancer (mBC) compared to the combination of lapatinib and Xeloda® (capecitabine). The EMILIA study, in people with HER2-positive mBC who had previously received Herceptin® (trastuzumab) and taxane chemotherapy, has now met both co-primary efficacy endpoints of significant improvements in overall survival and progression-free survival (PFS). These data will be presented at an upcoming medical meeting.

Genentech has submitted a Biologics License Application (BLA) for trastuzumab emtansine to the U.S. Food and Drug Administration (FDA), and Roche will shortly be submitting a Marketing Authorization Application to the European Medicines Agency (EMA).

“We are extremely pleased to announce that people treated with trastuzumab emtansine survived significantly longer than those who received a standard option for this aggressive advanced breast cancer,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “We believe that antibody-drug conjugates have the potential to change the future treatment of cancer, and we look forward to working with regulatory authorities in the hope of bringing another potential treatment option to people with HER2-positive metastatic breast cancer.”

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.

Trastuzumab emtansine is an antibody-drug conjugate (ADC) 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. Genentech has been researching the HER2 pathway for three decades. The development of HER2-targeted therapies represents one of the first successful examples of personalized healthcare.

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