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news.Genentech, a wholly owned member of the Roche Group, has announced that a Phase III study (AVAGAST) did not meet its primary endpoint of showing Avastin (bevacizumab) plus Xeloda (capecitabine) or 5-FU and cisplatin chemotherapy extended the lives of people with inoperable or advanced stomach (gastric) cancer, compared to chemotherapy alone.
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AVAGAST is a multicenter, randomized, double-blind, placebo-controlled Phase III study designed to evaluate Avastin plus Xeloda (capecitabine) or 5-FU and cisplatin chemotherapy compared to Xeloda or 5-FU and cisplatin chemotherapy alone in 774 patients with inoperable, locally advanced or metastatic cancer of the stomach or gastroesophageal junction.
Adverse events in the trial were consistent with those previously reported for Avastin and no new safety signals have been observed to date. Data from the study will be submitted for presentation at the 2010 American Society of Clinical Oncology (ASCO) annual meeting, June 4 to 8, 2010.
Hal Barron, executive vice president of global development and chief medical officer, said: “We are disappointed with these results because treatment options for stomach cancer are limited. However, we look forward to sharing the data with the medical community, including secondary endpoints. We are committed to developing medicines for people with stomach cancer, including Herceptin and Xeloda.”