Roche Holdings Ltd. (RHHBY - Free Report) reported positive top-line data on trastuzumab emtansine (T-DM1) from a late-stage trial (EMILIA) conducted in patients suffering from HER2-positive metastatic breast cancer, who had been treated with Herceptin (trastuzumab) and taxane chemotherapy. The phase III trial compared patients treated with trastuzumab emtansine to those treated with GlaxoSmithKline’s (GSK - Free Report) lapatinib plus Xeloda (capecitabine).
The trial results demonstrated that patients dosed with trastuzumab emtansine experienced a significantly longer progression free survival, compared to those who were dosed lapatinib and Xeloda. Additionally, the safety profile of the drug was consistent with previously-conducted studies.
We note that on the basis of the EMILIA study results, Roche plans to file for approval in the US and European Union (EU) in 2012 for the treatment of HER2-positive metastatic breast cancer.
We remind investors that in August 2010, the US Food and Drug Administration (FDA) had refused to accept Roche’s Biologics License Application (BLA) seeking accelerated approval for trastuzumab emtansine 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 one third of patients with advanced HER2-positive breast cancer.
The regulatory body had not accepted 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 has an agreement with ImmunoGen Inc. (IMGN - Free Report) for the global development of trastuzumab emtansine.
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