Roche Releases Data from CLEOPATRA Study on Perjeta

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Roche (RHHBY) announced final results from the phase III study, CLEOPATRA on breast cancer drug Perjeta (CLinical Evaluation Of Pertuzumab and TRAstuzumab).

The results of the randomized, double-blind, placebo-controlled study showed that adding Perjeta to Herceptin and docetaxel chemotherapy improved overall survival (OS) by 15.7 months in people suffering from previously untreated HER2-positive metastatic breast cancer (mBC) as compared to Herceptin and chemotherapy alone.

These results are a part of the final pre-specified OS analysis after a median follow-up of 50 months.

We note that Perjeta in combination with Herceptin and docetaxel chemotherapy is already approved in the U.S. and the EU for previously untreated HER2-positive mBC. The FDA granted accelerated approval to the Perjeta regimen as a neoadjuvant treatment (use before surgery) for HER2-positive early breast cancer (eBC).

Roche is well placed in the oncology market. In particular, Roche is a leader in the breast cancer market with the HER2 franchise and strong demand for drugs like Herceptin. The HER2 franchise includes Herceptin and drugs Perjeta and Kadcyla.

The approval of Perjeta in Europe, Kadcyla in the U.S. and Europe, and the approval of the subcutaneous formulation of Herceptin in Europe have further strengthened Roche’s HER2 franchise. Sales of HER2 franchise were up 20% in the first half of 2014 and we expect further traction from this franchise.

Roche currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the broader health care sector include Johnson & Johnson (JNJ), Shire (SHPG) and Bristol-Myers Squibb (BMY). All three carry a Zacks Rank #2 (Buy).

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