Dr. Tripathy on the Updated EMILIA T-DM1 Trial Results

Debu Tripathy, MD, co-leader of the Women’s Cancer Program at the Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, discusses results from the phase III EMILIA trial that examined the immunoconjugate T-DM1 (trastuzumab emtansine) for women with HER2-positive, unresectable, locally advanced or metastatic breast cancer.

In the EMILIA trial, the agent T-DM1 was tested in the second-line setting following progression on trastuzumab. The trial compared T-DM1 to the FDA approved standard treatment of lapatinib and capecitabine. The initial results from this trial were presented at the 2012 ASCO annual meeting and demonstrated a significant increase in progression-free survival (PFS) but overall survival (OS) was not yet statistically significant.

Following a confirmatory analysis of OS, the agent was submitted to the FDA for approval and the updated results were presented at the 2012 ESMO meeting. Overall, the agent showed an increase in median survival of 30.9 months for T-DM1 compared to 25.1 months for lapatinib and capecitabine.

Tripathy believes these results will provide a new platform for improving outcomes for patients with HER2-positive breast cancer.

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