Phase III randomised, open-label EMILIA study has met co-primary efficacy endpoints of overall survival and progression-free survival (PFS).
The study 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).
Genentech global product development head and chief medical officer Hal Barron said the people treated with trastuzumab emtansine survived significantly longer than those who received a standard option for this aggressive advanced breast cancer.
"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," Barron added.
On the basis of updated overall survival results, people in the lapatinib and Xeloda arm of EMILIA will be offered the option to receive trastuzumab emtansine, according to the company.
Trastuzumab emtansine, comprised of the antibody trastuzumab and the chemotherapy DM1 attached together using a stable linker, designed to target and inhibit HER2 signalling and deliver the chemotherapy DM1 directly inside HER2-positive cancer cells.