Bevacizumab (Avastin) by Roche has been found not effective to treat stomach cancer in a clinical study.
Avastin, which is considered a miracle drug in the century, is being studied worldwide in more than 450 clinical trials for multiple types of cancer.
Avastin, which works by starving tumours of blood, is already used to treat lung, colon and breast cancers.
Avastin clocked annual global sales of 6.2 billion Swiss francs ($5.77 billion) in 2009.
Phase III study (AVAGAST) did not meet its primary endpoint of showing bevacizumab (Avastin) 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, Genentech, Inc., a wholly owned member of the Roche Group announced.
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,” stated Hal Barron, M.D., executive vice president, Global Development and chief medical officer.
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.
Bevacizumab (Avastin) in combination with intravenous 5-FU-based chemotherapy is indicated for first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum.
In clinical trials for different cancer types, there were additional serious and sometimes fatal side effects that occurred in more people who received Bevacizumab (Avastin) than in those in the comparison group.
The formation of an abnormal passage from parts of the body to another part (non-GI fistula formation) was seen in 0.3 percent or less of people. Severe to life-threatening stroke or heart problems were seen in 2.4 percent of people. Too much protein in the urine, which led to kidney problems, was seen in less than 1 percent of people.
Additional serious side effects that occurred in more people who received Avastin than those in the comparison group included severe to life-threatening high blood pressure, which was seen in 5 percent to 18 percent of people, and nervous system and vision disturbances (reversible posterior leukoencephalopathy syndrome), which was seen in less than 0.1 percent of people. Infusion reactions with the first dose of Avastin were uncommon and occurred in less than 3 percent of people and severe reactions occurred in 0.2 percent of people.
Xeloda is indicated as a monotherapy to treat colorectal cancer that has spread (metastasized) to other parts of the body.
Herceptin is approved for the adjuvant treatment of HER2-overexpressing, node-positive or node-negative (ER/PR-negative or with one high-risk feature) breast cancer. Herceptin can be used several different ways: as part of a treatment regimen including doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; with docetaxel and carboplatin; as a single agent following multi-modality anthracycline-based therapy.
Genentech, a leading biotechnology company, is a wholly owned member of the Roche Group. The company has headquarters in South San Francisco, California.