Trastuzumab emtansine: Phase III data
Top-line data from the open-label, international Phase III EMILIA trial in 991 HER2-positive mBC patients showed that 3.6 mg/kg IV T-DM1 every 3 weeks met the co-primary endpoint of significantly improving PFS vs. Tyverb lapatinib plus Xeloda capecitabine. Data for the co-primary endpoint of OS are not yet mature. The trial enrolled patients with HER2-positive mBC who had previously received treatment with Herceptin trastuzumab and a taxane chemotherapy. The Genentech Inc. unit of Roche plans to submit the data for presentation at the American Society of Clinical Oncology meeting in June. Roche and Genentech plan to submit an MAA and BLA in 2H12 for T-DM1 to treat HER2-positive mBC in previously treated patients.
In 2010, FDA refused to file a BLA seeking accelerated approval for T-DM1 for third-line treatment of advanced HER2-positive breast cancer. FDA said T-DM1 trials did not meet the standard for accelerated approval because all available treatments approved for metastatic breast cancer, regardless of HER2 status, had not been exhausted in the study population (see BioCentury, August 30, 2010). ...