Roche's Herceptin Impresses - Analyst Blog

Roche Holdings Ltd. (RHHBY) recently reported positive mid-stage data on Herceptin given in combination with pertuzumab and docetaxel in women with early-stage, HER2-positive breast cancer. In a phase II trial (NEOSPHERE), the two drugs – Herceptin and pertuzumab – along with docetaxel were administered to patients prior to surgery.

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 that 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.

On the basis of the positive mid-stage trial results, Roche plans to initiate a phase III trial in HER2-positive adjuvant breast cancer patients in 2011. Additionally, data from another late-stage trial (CLEOPATRA) evaluating the efficacy and safety profile of pertuzumab and Herceptin plus chemotherapy as a first-line regimen in women with HER2-positive metastatic breast cancer are expected by the end of 2011.

Herceptin, which is currently approved for HER2-positive breast cancer and advanced HER2-positive stomach cancer, posted sales of 4.2 billion Swiss francs for the nine months ended September 30.

Herceptin faces intense competition from GlaxoSmithKline plc's (GSK) Tykerb.

We currently have a Zacks #2 Rank (short-term Buy rating) on Roche. The positive data on Herceptin came as a breather for the company, caught up as it is with a number of pipeline debacles. These include the negative results on Avastin in gastric and prostate cancer patients, discontinuation of development of ocrelizumab for rheumatoid arthritis due to an unfavorable risk-benefit profile and a delay in the development of type II diabetes treatment, taspoglutide, due to a higher incidence of hypersensitivity reactions in late-stage trials.