Based on these updated overall survival results, people in the lapatinib and Xeloda arm of EMILIA are being offered the option to receive trastuzumab emtansine. In addition, Genentech has opened 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.About the EMILIA Study EMILIA (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 chemotherapy. The study has met both co-primary efficacy endpoints of progression-free survival (PFS, as assessed by an independent review committee) and overall survival. PFS and safety results from the EMILIA study were previously reported at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2012 and include:
- 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 (HR=0.65, 35 percent reduction in risk of disease worsening or death, p<0.0001; median PFS 9.6 months vs. 6.4 months).
- People who received trastuzumab emtansine had a longer time before their cancer symptoms worsened (time to symptom progression; a secondary endpoint and patient-reported measure of quality of life) compared with those who received lapatinib plus Xeloda (7.1 months vs. 4.6 months; p<0.0001).
- Fewer people who received trastuzumab emtansine experienced Grade 3 or higher AEs than those who received lapatinib plus Xeloda (40.8 percent vs. 57.0 percent). 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 generally returned to normal by the time of the next dose of trastuzumab emtansine) and anemia (2.7 percent vs. 1.6 percent).
Genentech licenses technology for trastuzumab emtansine under an agreement with ImmunoGen, Inc.Building on the results of trastuzumab emtansine studies to date, there are approximately 25 ADCs in Genentech and Roche’s pipeline. About Breast Cancer Breast cancer is the most common cancer among women worldwide. According to the American Cancer Society, approximately 229,000 people will be diagnosed with breast cancer, and 40,000 will die from the disease in 2012. In HER2-positive breast cancer, increased quantities of the Human Epidermal growth factor Receptor 2 (HER2) are present on the surface of the tumor cells. This is known as “HER2 positivity” and affects approximately 25 percent of people with breast cancer. HER2-positive cancer is a particularly aggressive form of breast cancer. About Genentech Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.