BASEL, Switzerland — Roche has announced the topline results of its first randomized trial of trastuzumab emtansine (T-DM1) in HER2-positive metastatic breast cancer.
The Phase II trial, known as TDM4450g, compared T-DM1 single agent to the combination of trastuzumab and chemotherapy (docetaxel) in previously untreated patients.
The results showed that patients treated with trastuzumab emtansine (T-DM1) in this study lived significantly longer with their disease under control and experienced fewer side effects typical of chemotherapy.
“These encouraging data support our ongoing development program for T-DM1 in first-line HER2-positive metastatic breast cancer,’’ said Dr. Hal Barron, chief medical officer and head of global development.
“T-DM1 is a novel treatment with the potential to improve outcomes for patients with HER2-positive breast cancer due to its efficacy and favorable safety profile,” Barron said.
Data from the TDM4450g study will be submitted for presentation at a future medical congress.
An earlier analysis of this study presented at the 35th Congress of the European Society of Medical Oncology (ESMO) in 2010 showed encouraging results in tumor shrinkage (overall response rate) in patients with a minimum of four months of follow-up.
In addition, the study showed that T-DM1 significantly reduced the burden of typical side effects associated with conventional chemotherapy.
Breast cancer is the most common cancer among women worldwide. Each year about 1.4 million new cases of breast cancer are diagnosed worldwide, and over 450,000 people will die of the disease annually.
In HER2-positive breast cancer, increased quantities of the HER2 receptor are present on the surface of the tumor cells. This is known as “HER2 positivity” and affects approximately 15 to 25 percent of women with breast cancer.