A late-stage study of Swiss drugmaker Roche's Avastin indicates that the drug is able to extend the time patients with ovarian cancer live without their disease worsening.
The company said the OCEANS Phase III clinical trial met its primary endpoint in showing that progression free survival improved in women with the disease given a combination of Avastin (bevacizumab) and chemotherapy followed by maintenance therapy with the Roche's drug alone, compared to those given just a regimen of chemotherapy.
In further positive news, Roche said that data did not suggest any new safety issues and that adverse events were consistent with those seen in previous pivotal trials of Avastin. Full data from study are to be presented at an upcoming medical meeting, it added.
Data from trial bolster findings from two other Phase III studies (GOG 0218 and ICON7) in women with newly diagnosed ovarian cancer, which both showed that front-line use of Avastin alongside standard chemotherapy, followed by maintenance therapy with Avastin, significantly boosted the time women lived without their disease worsening, compared to those on a chemotherapy regimen.
Based on the results of these two trials, Roche has submitted an application to market the drug in Europe in the front-line setting, and is expecting a decision from the Committee for Medicinal Products for Human Use later this year. Across the Atlantic, Genentech is also planning to file Avastin for marketing in this setting sometime this year.
Despite the encouraging results, analysts have, however, questioned how easy it will be to gain approval for the drug in this indication given the absence of overall survival data.
Avastin, which was once touted a "pipeline in a product" because of its many potential applications in cancer, has had somewhat of a hard time of late.
In the last few months a study published in the Journal of Clinical Oncology reinforced prior evidence that the drug is linked to heart failure in patients treated for breast cancer, regulators are removing its breast cancer indication in the US after concluding that it neither prolongs overall survival nor provides a sufficient benefit in slowing disease progression, and, in the UK, the National Institute for Health and Clinical Excellence rejected Avastin's use on the National Health Service for colorectal cancer.