Roche reports positive results from gastric cancer study

Roche has reported positive results from ToGA, an international Phase III trial investigating the benefit of Herceptin as the first therapy for patients with advanced and inoperable stomach cancer.

According to Roche, the results showed that adding Herceptin (trastuzumab) to standard chemotherapy significantly prolongs lives of patients with HER2-positive stomach (gastric) cancer.

ToGA is the first randomized Phase III trial investigating the use of Herceptin in patients with inoperable locally advanced, recurrent or metastatic HER2-positive gastric cancer, said Roche. Approximately 3,800 patients were tested for HER2-positive tumors 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, maintained Roche. In addition, the overexpression of HER2 was also observed in stomach 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. Secondary endpoints for the study included progression-free survival, overall response rate, duration of response, safety and quality of life. In the ToGA study, no new or unexpected side effects were observed, said Roche.

William Burns, CEO of Roche’s pharmaceuticals division, said: The ToGA study shows for the first time that Herceptin extends the lives of patients in a cancer other than breast cancer. Advanced stomach cancer is a devastating disease for which there are currently few treatment options. Consequently, the targeted therapy Herceptin will become an integral part of treatment for this type of cancer.