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Final Overall Survival Data From EMILIA Trial

By: Meg Barbor, MPH
Posted: Wednesday, July 5, 2017

In patients with previously treated HER2-positive advanced breast cancer, ado-trastuzumab emtansine (formerly known as T-DM1) led to improved overall survival when compared with capecitabine plus lapatinib, according to an analysis of final overall survival data from the phase III EMILIA trial, reported by Véronique Diéras, MD, of the Institut Curie, Paris, and colleagues, in The Lancet Oncology. Approval of ado-trastuzumab emtansine was based on previously reported progression-free survival and interim overall survival data from the study.

A total of 991 patients previously treated with trastuzumab and a taxane were randomized to receive ado-trastuzumab emtansine (n=495) or oral capecitabine plus lapatinib (n=496). In this final descriptive analysis, median overall survival was longer with ado-trastuzumab emtansine than with the control regimen, capecitabine plus lapatinib (29.9 vs 25.9 months). In the control group, 136 of 496 patients (27%) crossed over to the ado-trastuzumab emtansine arm after the second interim overall survival analysis; despite this crossover, the study drug improved overall survival.

Grade ≥ 3 adverse events occurred in 48% of the ado-trastuzumab emtansine group and 60% of the control group. “The safety profile was similar to that reported in previous analyses, reaffirming trastuzumab emtansine as an efficacious and tolerable treatment in this patient population,” the investigators reported.