A detailed analysis of the phase-III ToGA study revealed an unprecedented survival benefit for patients whose tumours exhibited a particularly high level of HER2 when Roche's Herceptin (trastuzumab) was added to standard chemotherapy (Xeloda or intravenous 5-FU and cisplatin). Based on the significant findings of the ToGA study, Roche has submitted a label extension application with the EU Health Authorities for use of Herceptin in HER2-positive advanced gastric cancer. Applications for label extension in other regions of the world will follow as soon as possible.

The results of phase-III ToGA were presented at the joint 15th Congress of the European CanCer Organisation (ECCO) and 34th Congress of the European Society for Medical Oncology (ESMO) in Berlin, Germany. They illustrate the importance of an individualized approach to patient care and the opportunity that a targeted medicine may offer.

The analysis evaluated patient benefit according to the level of HER2 identified in their stomach tumour. Overall survival for patients with high levels of HER2 receiving Herceptin was 16 months on average versus 11.8 months for patients receiving chemotherapy alone.

"It is now clearly proven that Herceptin prolongs the lives of patients suffering from HER2-positive gastric cancer. As an investigator on this study and a treating physician, it is very rewarding to see a new effective treatment option emerging," said principal investigator, Professor Eric Van Cutsem, University Hospital Gasthuisberg, Leuven, Belgium. "The results of the ToGA study reinforce the need for early and accurate HER2 testing of all advanced gastric cancer patients."

"We are pleased to see the impressive benefit that the targeted therapy Herceptin provides for patients with HER2-positive stomach cancer. That this benefit is even greater in patients with higher levels of HER2 demonstrates the significant advances through personalized medicine," commented William M. Burns, CEO of Roche's Pharmaceuticals Division, "Herceptin will become the new standard of care and will make an important contribution to helping these patients."

Stomach cancer is the second most common cause of cancer-related death worldwide with over 1,000,000 new cases diagnosed each year. Stomach cancer is associated with poor prognosis and early diagnosis is challenging because most patients do not show symptoms until the later stages. Around 16% of stomach tumours express high levels of HER2 (IHC 3+ or IHC2+/FISH+).

ToGA is the first randomised phase-III trial investigating the use of Herceptin in patients with inoperable locally advanced, recurrent and/or metastatic HER2-positive gastric cancer. Approximately 3,800 patients were tested for HER2-positive tumours and 594 patients with HER2-positive disease were enrolled into the study. The rationale for conducting this trial was based on the knowledge that the targeted therapy Herceptin has demonstrated unprecedented efficacy in the treatment of HER2-positive breast cancer.

The primary objective of the study was to demonstrate superiority in overall survival of the Herceptin-containing treatment arm compared to the chemotherapy alone arm. The pre-planned interim analysis was triggered by the occurrence of 347 events. All patients who were included the study to receive Herceptin had a median overall survival increase by 2.7 months to 13.8 months. The response rate was increased with Herceptin from 34.5 % to 47.3%. Patients with tumours exhibiting higher levels of HER2 experienced even greater benefit from the addition of Herceptin.

Herceptin is marketed in the United States by Genentech, in Japan by Chugai and internationally by Roche. Since 1998, Herceptin has been used to treat more than 650,000 patients with HER2-positive breast cancer worldwide.

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics.