Roche’s Herceptin (trastuzumab) cuts the risk of breast cancer returning by 46% in women with the early form of the disease and who are positive for a receptor known as HER-2. HER2-positive breast cancer is a particularly aggressive tumour, which affects 20%-30% of women with breast cancer.

The firm unveiled the much-anticipated data from the so-called HERA study at this weekend’s American Society of Clinical Oncology meeting in Orlando, Florida, having earlier tantalized the scientific community by saying: “The combined data from over 8,000 patients analysed so far make a compelling case for Herceptin as an optimal treatment in HER2-positive early breast cancer and have potential to change the way breast cancer is managed” [[29/04/05e]].

The 5,100 patient, Phase III study investigated Herceptin given for 12 or 24 months versus observation only amongst women who had undergone a range of previous therapies. The one-year follow-up results, highlighted for the first time at ASCO, showed that – as well as halving the risk of the cancer returning - Herceptin plus background chemotherapy also reduced the risk of death by one-third.

Dr Martine Piccart, lead investigator of the HERA study, commented: “To see such impressive results with Herceptin in early-stage breast cancer, already at the interim analysis, is a major breakthrough in the treatment of this aggressive disease.” Roche says it will “now work closely with health authorities around the world” to get Herceptin approved in this new patient population.

This opening up of the marketplace is likely to send Herceptin sales into the stratosphere. Revenues were up 23% during the first quarter of 2005 to 390 million euros [[19/04/05b]], and look set to expand yet further.

Each year more than one million new cases of breast cancer are diagnosed worldwide, with a death rate of nearly 400,000 people per year.