- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
Trastuzumab Emtansine (T-DM1) Extends Survival in Metastatic Breast Cancer
Mortality risk reduced by 32% versus lapatinib plus capecitabine (Oct. 1)
Updated survival results from the EMILIA trial were announced on October 1 by Genetech. The phase III study showed that patients with previously treated HER2-positive metastatic breast cancer survived significantly longer when treated with trastuzumab emtansine (T-DM1) compared with those who received the combination of lapatinib and capecitabine.
The company reported that the risk of death was reduced by 32% in patients who received trastuzumab emtansine compared with those who received lapatinib plus capecitabine (hazard ratio: 0.68; P = 0.0006). Patients treated with trastuzumab emtansine survived a median of 5.8 months longer than those who received lapatinib and capecitabine (median overall survival: 30.9 months vs. 25.1 months, respectively).
No new safety signals were observed, and adverse events (AEs) were consistent with those seen in previous studies. Fewer patients who received trastuzumab emtansine experienced severe (grade 3 or higher) AEs than those who received lapatinib plus capecitabine (40.8% vs. 57.0%, respectively).
The updated survival results were published online in the New England Journal of Medicine.
Genentech has submitted a biologics license application (BLA) for trastuzumab emtansine to the FDA for use in patients with HER2-positive, unresectable, locally advanced or metastatic breast cancer who have received prior treatment with Herceptin (trastuzumab injection) and taxane chemotherapy.
Trastuzumab emtansine is an antibody–drug conjugate being studied in HER2-positive cancers. It consists of the antibody trastuzumab and the chemotherapy DM1 attached together using a stable linker. Trastuzumab emtansine is designed to target and inhibit HER2 signaling and to deliver the chemotherapy DM1 directly inside HER2-positive cancer cells. Trastuzumab emtansine binds to HER2-positive cancer cells and is thought to block out-of-control signals that make the cancer grow while also calling on the body's immune system to attack the malignant cells. Once trastuzumab emtansine is taken up by cancer cells, it is designed to destroy them by releasing the DM1.
For more information, visit the Genentech Web site.