Roche has suffered more disappointment with Avastin following the news that the oncology blockbuster has failed in another late-stage trial as a potential treatment for colon cancer.
The Swiss major has reported results from the 3,451-patient Phase III AVANT study which showed that Avastin (bevacizumab) in combination with chemotherapy did not extend disease-free survival in patients with early-stage colon cancer compared to those on chemotherapy alone. The data is in line with an earlier study, NSABP C-08, which demonstrated that the addition of one year of Avastin to chemotherapy did not result in a statistically significant improvement in DFS.
Hal Barron, Roche's chief medical officer, said that "while we originally hoped the significant survival benefit of Avastin seen in metastatic disease in colorectal cancer would be translated to the early setting, it is becoming increasingly clear that the effects of Avastin are different in the metastatic and early disease settings for patients with colon cancer". The company is now evaluating the data from the two studies "to help define the next steps for the ongoing Avastin adjuvant programme".
The news came just after the US Food and Drug Administration delayed a decision on whether Avastin should remain on the market as a first-line treatment for patients with advanced HER2-negative breast cancer. The extension was needed as the additional information provided by the company was deemed a major amendment" by the agency, which is now expected to issue a final decision by December 17.
The FDA granted accelerated approval for Avastin in breast cancer in 2008 based on studies suggesting it halted the progression of the disease for more than five months. However, two additional trials have failed to show benefit, and in July, an advisory panel voted 12 to 1 in favour of withdrawing approval for the breast cancer indication.