Roche Holdings Ltd. (RHHBY) recently reported positive data from a late-stage study of a combination treatment involving pertuzumab and Herceptin (trastuzumab). The CLEOPATRA study, which was conducted on patients with HER2-positive metastatic breast cancer (mBC), demonstrated that patients dosed with the combination of pertuzumab and Herceptin along with docetaxel, experienced longer progression-free survival (primary endpoint) compared to those patients who received only Herceptin and docetaxel.
Last year in December, Roche had reported positive data on a mid-stage study (NEOSPHERE) on Herceptin when given in combination with pertuzumab and docetaxel in women with early-stage, HER2-positive breast cancer. The study demonstrated that the combination drug increased the rate of complete tumor disappearance (45.8%) in the breast, as compared with patients who were given Herceptin plus docetaxel (29.0%).
The NEOSPHERE trial enrolled more than 400 women with newly diagnosed HER2-positive locally advanced breast cancer who had never received Herceptin. These patients were randomized to four cycles of neoadjuvant treatment (prior to surgery), which lasted for 12 weeks.
Herceptin, which is currently approved for HER2-positive breast cancer and advanced HER2-positive stomach cancer, posted sales of 1.4 billion Swiss francs for three months ended March 31, 2011.
Herceptin faces intense competition from GlaxoSmithKline plc’s (GSK) Tykerb.
Roche’s another mBC treatment, Avastin, was recently in news when the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended that the agency should withdraw its approval for the use of Avastin (bevacizumab) in combination with paclitaxel in previously untreated (first-line) HER2-negative metastatic breast cancer. The FDA Commissioner’s final call on this matter is awaited.
The recommendation is not expected to impact other indications of the drug. Avastin is approved in the US for treating other types of cancer and in other countries for treating metastatic breast cancer.
In the short run, we have a Zacks #3 Rank (Hold rating) on Roche.
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