T-DM1 meets OS endpoint

Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit said T-DM1 met the co-primary endpoint of improving overall survival vs. Tykerb lapatinib plus Xeloda capecitabine in the Phase III EMILIA trial for second-line HER2-positive metastatic breast cancer. Genentech said detailed data will be presented at an upcoming medical conference. The unit submitted a BLA to FDA for T-DM1 to treat HER2-positive metastatic breast cancer in previously treated patients, while Roche plans to submit an MAA to EMA soon. Additionally, Genentech plans to open an Expanded Access Program in the U.S. to provide T-DM1 while the company seeks regulatory approval.

In June, the partners reported that median OS had not yet been reached in the T-DM1 arm, while the Tykerb/Xeloda arm led to OS of 23.3 months. The trial enrolled 991 patients with HER2-positive locally advanced or metastatic breast cancer who had previously received treatment with Herceptin trastuzumab and a taxane-based chemotherapy. T-DM1 previously met the co-primary endpoint of progression-free survival (PFS) (see BioCentury, June 4). ...