Roche's Herceptin has long-term benefit in HER2-positive early breast cancer: study

Roche announced Wednesday that an analysis of new data from the ongoing, late-stage HERA study found that women with HER2-positive early breast cancer taking Herceptin (trastuzumab) had a 25-percent reduction in risk of disease recurrence after four years follow-up, compared with patients who did not take the drug.

The study, which enrolled more than 5000 women, compared one year of Herceptin treatment versus no treatment with the drug, with a median follow-up of four years after entry into the study. Results showed that roughly 79 percent of women given Herceptin remained cancer-free, which Roche said was a significant increase when compared with the 73 percent of women in the observation arm of the study whose disease did not recur. In addition, the data indicated that almost 90 percent of Herceptin-treated women were still alive after four years.

Lead investigator Martine Piccart stated that "HERA is the first of the four large Herceptin studies in early HER2-positive breast cancer to substantiate the long-term benefit derived from one year of treatment." The latest findings from HERA were presented at the Primary Therapy in Early Breast Cancer conference. Final results from the study, in which Roche and the Breast International Group are assessing the benefits of adjuvant Herceptin treatment in this group of patients, are due in 2011.

Roche's life cycle leader for Herceptin, Peter Braun, indicated that the treatment, which generated sales of 5.1 billion Swiss francs ($4.41 billion) in 2008, has the potential for further growth in the years ahead, particularly in emerging markets. Regarding competition from GlaxoSmithKline's Tyverb (lapatinib), Braun suggested Herceptin presents "quite a high hurdle," noting that, thus far, GlaxoSmithKline appears to have "over-promised, and under-delivered."

GlaxoSmithKline spokesperson Stephen Rea remarked that the UK drugmaker anticipates Tyverb use will increase over time and as additional data become available.

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