Roche has reported that 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 (PFS).

In the study, Avastin in combination with radiation and temozolomide chemotherapy significantly extended the time people with this aggressive form of primary brain cancer lived without their disease getting worse (PFS), compared to those treated with radiation and temozolomide chemotherapy plus placebo. Data for final overall survival (OS), 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 tumour types for approved indications. Full data from the AVAglio study will be submitted for presentation at an upcoming medical meeting.

“This study showed that people with glioblastoma, a particularly devastating and aggressive cancer without many treatment options, lived significantly longer without their disease worsening when Avastin was added to radiation and temozolomide chemotherapy,” said Hal Barron M.D., chief medical officer and head global product development.

Avastin is currently approved in the United States and over 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 (relapsed setting). The approval in the USA was granted under the Food and Drug Administration’s (FDA) accelerated approval programme.

Roche plans to discuss these phase III results with global regulatory authorities, including the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).

AVAglio is a phase III, randomised, double blind, placebo controlled trial that assessed the efficacy and safety profile of Avastin in combination with radiation and temozolomide chemotherapy following surgery or biopsy in patients with newly diagnosed glioblastoma.

The co-primary endpoints of the study were OS and PFS as assessed by trial investigators. Secondary endpoints included one- and two-year survival rates, PFS as assessed by an independent review committee, safety profile, and quality of life measures.

Glioma (cancer of the glial cells) is the most common type of malignant primary brain tumour (a tumour that originates in the brain), accounting for approximately one third of all cases diagnosed. Glioblastoma (or glioblastoma multiforme; GBM) is the most common and the most aggressive type of glioma. Glioblastoma affects approximately 13,000 people per year in the EU. Glioblastoma is a rational therapeutic target for Avastin as these tumours have among the highest levels of vascular endothelial growth factor (VEGF) of any solid tumour.