Data from the ToGA study presented at the American Society for Clinical Oncology Annual Meeting in Orlando, Florida showed that adding Herceptin (trastuzumab) to standard chemotherapy (Xeloda or intravenous 5-FU and cisplatin) prolongs the lives of patients with this aggressive cancer on average by nearly three months to 13.8 months. Advanced stomach (gastric) cancer is associated with a poor prognosis; the median survival time after diagnosis is approximately 10 months with currently available therapies.

The international phase-III study also showed that Herceptin reduces the risk of death in patients with HER2-positive advanced and inoperable stomach cancer by 26 per cent compared to patients not receiving Herceptin. Patients with tumours exhibiting high levels of HER2 experienced even greater benefit from the addition of Herceptin, their lives were extended to 16 months on average.

"To see this unprecedented survival benefit for patients with HER2-positive stomach cancer is enormously rewarding," said principle investigator Prof Eric Van Cutsem, University Hospital Gasthuisberg, Leuven, Belgium. "There is a high unmet medical need in advanced stomach cancer. The data from the ToGA study show that targeted therapy with Herceptin delivers a major advance in this therapeutic area."

Stomach cancer is the second most common cause of cancer-related death in the world with over 1,000,000 new cases diagnosed each year. Early diagnosis is challenging because most patients do not show symptoms in the early stage. Approximately 22 per cent of stomach tumours are HER2-positive. This rate is the same in Europe and in Asia, where stomach cancer is particularly frequent.

"Herceptin has brought significant benefit to women suffering from HER2-positive breast cancer. We are extremely pleased to see its impressive benefit extending to patients with stomach cancer," commented William M Burns, CEO of Roche's Pharmaceuticals Division. "The targeted therapy Herceptin will become the new standard of care and we can make an important contribution in helping these patients live longer."

Herceptin is already well established as the foundation of care for patients with HER2-positive breast cancer and now, based on the ToGA results, Roche will seek regulatory approvals for the use of Herceptin in HER2-positive advanced gastric.

Herceptin is a humanised antibody, designed to target and block the function of HER2, a protein produced by a specific gene with cancer-causing potential.

Xeloda (capecitabine) is a highly effective targeted oral chemotherapy offering patients a survival advantage when taken on its own or in combination with other anticancer drugs.