Phase 3 Trial Update of Trastuzumab Emtansine for Metastatic HER2-positive Breast Cancer

ImmunoGen announced that Roche has reported that updated results from its EMILIA Phase 3 trial show that patients treated with trastuzumab emtansine had a significant improvement in overall survival compared to those randomized to standard-of-care therapy. Also reported today was that Genentech has submitted a Biologics License Application (BLA) for trastuzumab emtansine to the FDA.

EMILIA was designed to evaluate trastuzumab emtansine for the treatment of patients with metastatic HER2-positive breast cancer who have previously received trastuzumab (Herceptin; Genentech) and a taxane. Patients enrolled were randomized to treatment with trastuzumab emtansine – used alone – or with lapatinib (Tykerb; GlaxoSmithKline) plus capecitabine (Xeloda; Roche), standard-of-care in this setting.

The first EMILIA results were reported in June 2012, and included that trastuzumab emtansine significantly improved progression-free survival compared to standard-of-care therapy and that fewer of the trastuzumab emtansine-treated patients experienced Grade 3 or higher (severe) adverse events. A previous interim analysis of overall survival demonstrated a trend towards improved overall survival in the trastuzumab emtansine-treated patients.

Trastuzumab emtansine is an antibody-drug conjugate (ADC) 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.   

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