Avastin fails in phase III study
pharmafile | February 24, 2010 | News story | Research and Development | Roche, avastin, gastric cancer, stomach cancer
Roche’s Avastin does not help patients with a severe form of stomach cancer to live longer, according to the results of a phase III trial.
The AVAGAST global study investigated the use of Avastin (bevacizumab) in combination with Roche’s own Xeloda (capecitabine) or fluorouracil and cisplatin chemotherapy in 774 patients with inoperable, advanced or metastatic gastric cancer.
The trial did not meet its primary endpoint of extending overall survival in patients treated with Avastin in combination with chemotherapy compared to the same chemotherapy plus placebo.
Roche chief medical officer and executive VP of global development Hal Barron 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.”
The trial’s secondary endpoints include progression-free survival, time to progression, overall response rate, duration of response during first-line therapy, disease control rate and safety.
Roche said the study’s findings will not affect Avastin’s use in its approved indications, which include breast cancer, non-small cell lung cancer and kidney cancer, and that the drug’s development programme in other tumour types will continue as planned.
The three chemotherapy treatments – Roche’s Xeloda, fluorouracil and cisplatin are the current oncology model for advanced gastric cancer.
Roche is also exploring the use of its breast cancer drug Herceptin to treat gastric cancer, and last year a phase III study showed the treatment improved survival rates in patients with tumours that had high amounts of the HER-2 receptor.
Approximately one million people are diagnosed each year with stomach cancer making it the fourth most common cancer and the second leading cause of cancer related death worldwide.
Each year the disease causes an estimated 800,000 deaths and is more common in Asia and South America than in North America and Europe.
No safety concerns were raised from the trial and data from the study will be submitted for presentation at the 2010 American Society of Clinical Oncology in June.
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