Roche has announced that a recently completed study indicates that adding Avastin to radiation and chemotherapy significantly extends the time people with an aggressive form of brain cancer live without their disease worsening. According to Roche, the phase III AVAglio study of Avastin plus radiation and temozolomide chemotherapy in people with newly diagnosed glioblastoma met its co-primary endpoint of a significant improvement in progression-free survival. In the study, Avastin, used with radiation and temozolomide, significantly extended the time people with glioblastoma lived without disease progression, compared to those treated with radiation and temozolomide plus a placebo. Data for final overall survival, the other co-primary endpoint, are expected in 2013. No new safety findings were observed in the AVAglio study, and adverse events were consistent with those seen in previous trials of Avastin across tumor types for approved indications. Full data from the AVAglio study will be submitted for presentation at an upcoming medical meeting.
Avastin is currently approved in the United States and more than 30 countries worldwide for the treatment of glioblastoma as a single agent and in some countries in combination with irinotecan for adult patients with progressive disease following prior therapy. The approval in the United States was granted under the Food and Drug Administration's (FDA) accelerated approval program. Roche plans to discuss these phase III results with global regulatory authorities, including the European Medicines Agency (EMA).