Roche released an announcement today in regards to its phase three trial called EMILIA. The program compared performance of its new drug Trastuzumab Emtansine against standard treatments for HER2-positive Metastatic Breast Cancer that use lapatinib plus Xeloda® (capecitabine).
Patients were enrolled in the study having previously received Herceptin® and ataxane (chemotherapy). The trial the compared the patients on each treatment looking at progression-free survival, (PFS) ie. how long the patients lived without their disease becoming worse. Overall survival rates are not ready for release yet, but it appears that Trastuzumab Emtansine controlled the metastatic cancer better than standard treatments.
Hal Barron, M.D., Chief Medical Officer and Head, Global Product Development explains that :
"Trastuzumab emtansine represents a new approach for the treatment of patients with HER2-positive breast cancer that comes from our decades of research on the HER pathway ... We are excited about the EMILIA results because trastuzumab emtansine is our first antibody drug conjugate and it may help people who still need more treatment options for this aggressive disease. We will work to submit these data to regulatory authorities as quickly as possible."
Trastuzumab emtansine is an investigational type of medicine called an antibody-drug conjugate (ADC). The antibody trastuzumab is combined with the chemotherapy agent DM1, and the two are attached together using a stable linker. Its aim is to target and inhibit HER2 signaling and deliver the chemotherapy directly inside HER2-positive cancer cells. Trastuzumab emtansine reinforces Roche's personalized healthcare approach of developing targeted medicines to fight cancer.
EMILIA 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 mBC whose disease progressed after initial treatment with Herceptin and a taxane-based chemotherapy.
- Participants in the trastuzumab emtansine arm received: Trastuzumab emtansine 3.6 mg/kg every three weeks.
- Participants in the lapatinib and Xeloda arm received: Lapatinib 1250 mg daily and Xeloda 2000 mg/m2, days 1 - 14, every three weeks.
Based on the positive outcome of its trial, Roche says it plans to submit a Marketing Authorization Application to the European Medicines Agency (EMA) this year for trastuzumab emtansine in HER2-positive mBC. In addition, Genentech plans to submit a Biologics License Application for trastuzumab emtansine to the U.S. Food and Drug Administration (FDA) this year.
Written by Rupert Shepherd