Additional OS details for T-DM1

Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit said T-DM1 led to median overall survival (OS) of 30.9 months vs. 25.1 months for Tykerb lapatinib plus Xeloda capecitabine in the Phase III EMILIA trial in second-line HER2-positive metastatic breast cancer (HR=0.68, p=0.0006). The companies had said in August that the trial met the OS co-primary endpoint but did not provide detailed data. The companies also previously reported that T-DM1 met the co-primary endpoints of progression-free survival (PFS) (9.6 vs. 6.4 months, HR=0.65, p<0.0001) (see BioCentury Extra, Aug. 27).

In August, Genentech submitted a BLA to FDA for T-DM1 to treat HER2-positive, unresectable locally advanced or metastatic breast cancer who have received prior treatment with Herceptin and a taxane-based chemotherapy. Roche submitted an MAA to EMA for T-DM1 in the indication. 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. Data were published in the New England Journal of Medicine and presented at the European Society for Medical Oncology meeting in Vienna. ...