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02/23/10
Phase 3 Study of Avastin Plus Chemotherapy Did Not Meet Primary EndpointSOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, Inc., a wholly owned member of the Roche Group, today 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. 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.“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,” said Hal Barron, M.D., executive vice president, Global Development and chief medical officer. “We are committed to developing medicines for people with stomach cancer, including Herceptin and Xeloda.” These findings do not impact Avastin’s approved uses or its development program. Avastin is being studied worldwide in more than 450 clinical trials for multiple types of cancer. About AVAGAST (AVF4200g) 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. Patients in the study had received no prior treatment for advanced or metastatic stomach cancer. The primary endpoint of the study is overall survival. Secondary endpoints of the study include progression free survival, time to progression, overall response rate, duration of response during first line therapy, disease control rate and safety.
Source: Genentech | |||||