Genentech, a member of the Swiss pharmaceutical company Roche (SIX: RO, ROG; OTCQX: RHHBY), today announced updated results from the Phase III EMILIA study, which showed that trastuzumab emtansine (T-DM1) significantly improved overall and progression-free survival of people with HER2-positive metastatic breast cancer compared to the combination of lapatinib and Roche’s Xeloda® (capecitabine).
Breast cancer is the most common cancer among women in the world, with a reported 12.7 million diagnosed cases in 2008 worldwide, according to the American Cancer Society. HER2-positive breast cancer is defined as testing positive for human epidermal growth factor 2, which promotes the growth of cancer cells. About 20 percent of women test positive for this more aggressive form of breast cancer.
The EMILIA study tested the T-DM1, an antibody-drug conjugate, which links the antibody trastuzumab and a chemotherapy agent DM1. The trial enrolled 991 people with HER2-positive breast cancer, which was locally advanced or metastisized after initial treatment with Herceptin® and taxane chemotherapy.
The combination therapy is carried directly into cancer cells, which is believed to make T-DM1 a more efficacious and have fewer side effects. Hal Barron, chief medical officer at Roche, said in a statement about the most recent results, “We believe that antibody-drug conjugates have the potential to change the future treatment of cancer.”
Other endpoints in the study include one-year and two-year survival rates, safety profile, investigator-assed progression-free survival, objective response rate, duration of response and quality of life. These results were not reported in the announcement.
At the American Society for Clinical Oncology (ASCO) meeting in June, results had be presented that T-DM1 was found to reduce the risk of death and disease progression by 35% and the therapy had significantly lower presentation of Grade C (severe) adverse effects.
Genentech has submitted a Biologics License Application for trastuzumab emtansine to the U.S. Food and Drug Administration (FDA), and Roche will be submitting a Marketing Authorization Application to the European Medicines Agency (EMA).
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
