Roche Holdings Ltd. (RHHBY) recently announced positive data from a mid-stage trial of trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer. The phase II trial (TDM4450g) was conducted to compare T-DM1 with the combination of Herceptin (trastuzumab) and chemotherapy (docetaxel) in treatment naïve patients.
The trial results demonstrated that patients treated with T-DM1 achieved higher progression free survival (the primary endpoint of the study) and experienced fewer of the side effects associated primarily with chemotherapy.
In August last year, the US Food and Drug Administration (FDA) refused to accept the Roche’s Biologics License Application (BLA) seeking accelerated approval for T-DM1 as a treatment for breast cancer.
The BLA was submitted by Roche in July 2010 on the basis of mid-stage trial results. The data demonstrated that the candidate reduced the size of tumors in a third of women with advanced HER2-positive breast cancer. On an average, these women had received seven treatments earlier.
The regulatory body did not accept the BLA because it believed that the patients in the phase II study had not tried all possible medications available for the treatment of metastatic breast cancer.
Roche is currently conducting a late-stage trial (EMILIA) with the candidate. The study is comparing T-DM1 with GlaxoSmithKline plc’s (GSK) lapatinib (Tykerb), which is administered in combination with capecitabine (Xeloda). The study is being conducted in women with advanced HER2-positive breast cancer, whose disease worsened after initial treatment.
Roche has an agreement with ImmunoGen Inc. (IMGN) for the global development of T-DM1 and the companies plan to file a new BLA with the FDA in mid 2012, which will be supported by the phase III (EMILIA) study results.
GLAXOSMITHKLINE (GSK): Free Stock Analysis Report
IMMUNOGEN INC (IMGN): Free Stock Analysis Report
Zacks Investment Research
