Roche and Genentech’s marketing potential for the anticancer agent Herceptin (trastuzumab) have taken a turn for the better after the companies unveiled data from two late-stage clinical studies showing a significant boost to survival rates for women with a form of early breast cancer.

“These results in early-stage HER2-positive breast cancer suggest that Herceptin may increase the chance of long-term survival by preventing the development of metastatic disease, and while further follow-up is necessary, they offer new hope to women suffering from this particularly aggressive form of breast cancer,” said William Burns, chief executive of Roche’s Pharmaceuticals Division. The firm has called for patients’ HER2 status to be identified as part of the diagnosis process. HER2-positive breast cancer, where increased quantities of the HER2 protein are present on the surface of the tumour cells, is a particularly aggressive form of the disease and responds poorly to chemotherapy.

Full results will be presented at the American Society of Clinical Oncology meeting in May, but Roche and Genentech say that primary and secondary endpoints were met in both disease-free and overall survival, and point out this is the first time that a targeted therapy has demonstrated a clinical benefit in early-stage HER2-positive breast cancer.

Herceptin, which is currently approved for use in advanced breast cancer, reeled in over 390 million Swiss francs for Roche alone during the first quarter of 2005, up 23% [[19/04/05b]], and the company will certainly be hoping to improve yet further on this performance. It is also investigating Herceptin in a larger early breast cancer trial, dubbed HERA, which involves a wider range of chemotherapy regimens. Over 5,000 patients have already been enrolled.

- Meanwhile, Roche Diagnostics says it has won Food and Drug Administration approval to market Cobas AmpliScreen for detection of the hepatitis B virus in blood screening – the first test of its kind to gain US clearance. In a clinical study, Cobas AmpliScreen HBV identified two so-called “window cases” (cases within the time between infection and detection) which may have gone undetected by currently licensed products. Said Jed Gorlin, of Memorial Blood Centers, Minneapolis: “The current hepatitis B surface antigen assays are very sensitive, but on rare occasions, may still miss small, but potentially infectious amounts of hepatitis B.”