Today, results from the trial of a new investigational medication, trastuzumab emtansine a targeted antibody drug conjugate (known as ADC), have shown that the drug considerably increases the time that advanced HER2-positive breast cancer is kept in check while reducing adverse effects.
A Phase II investigation, TDM4450g, in individuals with previously untreated HER2-positive metastatic or advanced breast cancer (mBC), showed that those who received trastuzumab emtansine (T-DM1) benefited from an extra five months of life, without their illness getting worse when compared to the best standard of care currently. Herceptin® and chemotherapy. Median progression-free survival (PFS) revealed an increase from 9.2 months with Herceptin® and chemotherapy, to 14.2 months with T-DM1, HR=0.59.
Professor Paul Ellis, Professor of Medical Oncology, Guy’s Hospital, explained:
“These data represent an important advance in personalized healthcare for the treatment of HER2-positive metastatic breast cancer .This novel and targeted approach has shown that we are now able to stop the cancer in its tracks while reducing many of the common side effects normally associated with standard chemotherapy treatment.”
Less adverse effects were experienced in those who received T-DM1 in comparison to individuals who received Herceptin® plus chemotherapy, with the rate of adverse effects needing hospitalization (Grade 3 or higher adverse events) reduced by almost half (46.4% with T-DM1 compared to 89.4% with Herceptin® and chemotherapy).
T-DM1 is a new investigational drug, known as an antibody drug conjugate or ADC, which contains a chemotherapy agent (maytansine) stably connected to the monoclonal antibody, Herceptin®. The benefit of T-DM1 is that the medication targets and inhibits HER2 signaling and at the same time transfers the chemotherapy directly inside HER2-positive cancer cells. By targeting the chemotherapy to the tumor cells, it avoids several adverse effects usually observed with chemotherapy.
On September 25 in Stockholm, Sweden, the information will be presented at the 2011 European Multidisciplinary Cancer Congress and was highlighted by the European Society for Medical Oncology in the official press program for the congress.
137 patients with previously untreated HER2-positive mBC were enrolled in the TDM44500g Phase II, international, multicenter, two-arm, open-label investigation. Participants were randomly assigned to two groups. One group received trastuzumab emtansine (T-DM1) and the other Hercepin® plus docetaxel chemotherapy.
The initial endpoint of the investigation included PFS and safety profile. The second endpoint included overall survival (OS), one year-survival rate, objective response rate (ORR), duration of objective response and clinical benefit rate (CBR). Individuals who were receiving Herceptin® as well as chemotherapy were permitted to receive trastuzumab emtansine upon disease progression.
Written by Grace Rattue