Positive Phase III data have led Roche to submit a label-extension application to the EMEA for use of Herceptin in HER2-positive advanced gastric cancer. The company said it plans to submit label-extension applications in other countries as soon as possible.
The application follows a detailed analysis of data from the Phase III ToGA trial, which involved 594 stomach cancer patients who were positive for HER2. The results showed that in comparison with standard chemotherapy alone (Xeolda or intravenous 5-FU and cisplatin), the addition of Herceptin to chemotherapy increased overall survival by 2.7–13.8 months and led to a 26% reduction in the risk of death. For patients with particularly high levels of HER2, average survival increased from 11.8 months to 16 months when Herceptin was added to chemotherapy.
Roche says about 16% of stomach tumors express high levels of HER2. “It is now clearly proven that Herceptin prolongs the lives of patients suffering from HER2-positive gastric cancer,” according to Trial investigator, professor Eric Van Cutsem, M.D., at the University Hospital Gatsthuisberg, Leuven (Belgium). “The results of the ToGA study reinforce the need for early and accurate HER2 testing of all advanced gastric cancer patients.” The ToGA trial data were presented at 15 ECCO ESMO 34 in Berlin.