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Roche Holdings Ltd. (RHHBY - Free Report) reported positive data from a mid-stage trial on trastuzumab emtansine (T-DM1) in treatment-naïve patients with HER2-positive metastatic breast cancer. The phase II trial (TDM4450g) compared trastuzumab emtansine with the combination of Herceptin (trastuzumab) and chemotherapy (docetaxel).

The trial results demonstrated that treatment with trastuzumab emtansine led to a 41% decline in the risk of disease worsening or death in patients in the trastuzumab emtansine arm. The patients also lived a median of five months longer without their disease worsening. Additionally, these patients experienced fewer side effects as compared to the combination therapy of Herceptin and chemotherapy.

We remind investors that in August 2010, the US Food and Drug Administration (FDA) refused to accept the 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.

We note that Roche is conducting a late-stage trial (EMILIA) with the candidate. The study is comparing trastuzumab emtansine with GlaxoSmithKline’s (GSK - Free Report) 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 - Free Report) for the global development of trastuzumab emtansine 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.

We currently have a Zacks #3 Rank (short-term Hold rating) on Roche.

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