About the EMILIA StudyEMILIA (TDM4370g/BO21977) is an international, Phase III, randomized, open-label study comparing trastuzumab emtansine alone to lapatinib in combination with Xeloda in 991 people with HER2-positive locally advanced or metastatic breast cancer who had previously been treated with Herceptin and a taxane-based chemotherapy. The co-primary efficacy endpoints of the study are PFS (as assessed by an independent review committee) and overall survival. Other study endpoints include one-year and two-year survival rates, safety profile, PFS as assessed by investigator, objective response rate, duration of response and quality of life. Updated EMILIA Overall Survival Results This confirmatory analysis of overall survival in the Phase III EMILIA study crossed the pre-specified boundary that showed trastuzumab emtansine significantly extended the lives of people with HER2-positive mBC compared to the combination of lapatinib and Xeloda. Previously Presented EMILIA Results Results from the EMILIA study were presented at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2012:
- There was a significant improvement in the time people receiving trastuzumab emtansine (n=495) lived without their disease getting worse (PFS) compared to those who received lapatinib plus Xeloda (n=496), as assessed by independent review.
- The risk of disease worsening was reduced by 35 percent for people who received trastuzumab emtansine compared to those who received lapatinib plus Xeloda (HR=0.65, p<0.0001; median PFS 9.6 months vs. 6.4 months, respectively).
- Fewer people who received trastuzumab emtansine experienced Grade 3 or higher (severe) adverse events (AEs) than those who received lapatinib plus Xeloda, at 40.8 percent compared to 57.0 percent, respectively. For people receiving trastuzumab emtansine, compared to those receiving lapatinib plus Xeloda, the most common (occurring in more than 2 percent of participants) Grade 3 or higher AEs were low platelet count (12.9 percent vs. 0.2 percent), increased levels of enzymes released by the liver and other organs (aspartate aminotransferase: 4.3 percent vs. 0.8 percent; alanine aminotransferase: 2.9 percent vs. 1.4 percent; in most people, these levels had returned to normal by the time of the next dose of trastuzumab emtansine) and anemia (2.7 percent vs. 1.6 percent).
- A previous interim analysis of overall survival demonstrated a trend towards improved overall survival in people receiving trastuzumab emtansine compared to those who received lapatinib plus Xeloda. However, the data were not considered statistically significant at that time.