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Dr. Kimberly L. Blackwell from Duke University, presented results of the EMILIA study in HER2-positive metastatic breast cancer where T-DM1 was compared to treatment with the combination of Xeloda and Tykerb. The study included nearly 1,000 women whom had received prior treatment with Herceptin and a taxane.
The EMILIA study found that trastuzumab emtansine (T-DM1) can improve progression-free survival in "some" women with metastatic breast cancer. The final arbiter of clinical approval is overall survival. Median overall survival for patients treated with T-DM1 was not reached. Drug response is not a reliable predictor of overall survival. Median progression-free survival was longer in patients treated with T-DM1 than in those treated with the standard therapy (9.6 vs 6.4 months). The difference reached is statistically significant?
For patients with high levels of GPNMB (fully human monoclonal antibody CR011 directed against glycoprotein NMB) as well as triple negative breast cancer, the response rate was 36%, compared with no responses in the control group. In this group, a statistically significant progression-free survival benefit is currently observed (p=0.0032), the researchers say.
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