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Tickers in this Article: RHHBY, GSK, IMGN
Roche Holdings Ltd. (RHHBY) recently announced additional results from its phase III EMILIA study, which was conducted with trastuzumab emtansine. The study compared trastuzumab emtansine to GlaxoSmithKline's (GSK) Tykerb (lapatinib) along with Xeloda (capecitabine) in HER2-positive unresectable locally advanced or metastatic breast cancer patients who were previously treated with Herceptin and taxane chemotherapy. Results showed that patients who were treated with trastuzumab emtansine survived longer (risk of death was reduced by 32%) than those who were treated with the combination of lapatinib and Xeloda. Median overall survival was higher in the trastuzumab emtansine arm compared to patients receiving lapatinib and Xeloda (30.9 months vs. 25.1 months).

Roche now plans to offer patients in the Tykerb and Xeloda arm the option of being treated with trastuzumab emtansine.

Notably, in June this year, Roche had announced that the EMILIA study met its co-primary endpoint of progression-free survival (PFS). The study revealed that patients receiving trastuzumab emtansine showed 35% lower risk in disease worsening or death than those who received lapatinib and Xeloda.

Then, in August, the company announced that trastuzumab emtansine significantly improved overall survival (OS) in patients suffering from HER2-positive metastatic breast cancer in comparison to the combination.

Under an agreement with ImmunoGen Inc. (IMGN), Genentech, a member of the Roche Group, licenses technology for trastuzumab emtansine. Genentech submitted a Biologics License Application (BLA) for the candidate to the US Food and Drug Administration (FDA) for use in women suffering from HER2-positive, unresectable locally advanced or metastatic breast cancer. Roche also submitted a marketing authorization application for trastuzumab emtansine to the European Medicines Agency (EMA) for the same indication.

We remind investors that Roche had earlier submitted a BLA seeking accelerated approval for the candidate in July 2010 on the basis of mid-stage trial results. However, in August 2010, the FDA had refused the application 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 had then decided to continue with its EMILIA study to support the re-submission of the BLA.

Our Recommendation

Roche carries a Zacks #1 Rank (Strong Buy rating) in the short run. We are pleased with the company's progress with its oncology candidates. We expect several Roche oncology products to hit the market in the coming years.

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