Roche Holdings Ltd. (RHHBY), along with the Breast International Group (BIG), recently announced results from its phase III HERA trial of Herceptin (trastuzumab). Results from the trial showed that there was no difference in disease-free survival in women who received Herceptin for two years in comparison to those who received Herceptin for a year.
This means that Roche’s one-year Herceptin treatment will remain the standard therapy for patients suffering from early-stage HER2-positive breast cancer.
The study did not have any new safety findings. Notably, in 2005, interim results from the HERA study were originally reported. The study met its primary objective of significant benefit in disease-free survival for women who received Herceptin treatment for a year versus observation.
The one-year treatment regimen of Herceptin for HER2 positive breast cancer is approved by global regulatory agencies. In the first half of 2012, Roche reported Herceptin sales of CHF 2.9 billion.
Meanwhile, Roche is evaluating another candidate, trastuzumab emtansine, in HER2-positive unresectable locally advanced or metastatic breast cancer patients who were previously treated with Herceptin and taxane chemotherapy. The company reported additional data on trastuzumab emtansine from the phase III EMILIA study, which compared trastuzumab emtansine to GlaxoSmithKline’s (GSK) Tykerb (lapatinib) plus Xeloda (capecitabine).
A Biologics License Application (BLA) for the candidate has been submitted 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.
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 years ahead.
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