Genentech, a member of Roche Group, has reported that the Phase III AVAglio study of Avastin (bevacizumab) met its co-primary endpoint of a significant improvement in progression-free survival (PFS).
Avastin is designed for the treatment of adults with glioblastoma (cancer of the glial cells) who have progressive disease following prior therapy.
Avastin, a biologic antibody, directly binds to the VEGF protein, which plays a critical role throughout the lifecycle of the tumor to develop and maintain blood vessels.
The double-blind, placebo controlled, randomised Phase III trial is designed to assess the safety and efficacy of Avastin in combination with radiation and temozolomide chemotherapy, following surgery or biopsy in patients with newly diagnosed glioblastoma.
The secondary endpoints of the study include one and two-year survival rates.
The study results demonstrated that Avastin, in combination with radiation and temozolomide chemotherapy, extended the time patients with glioblastoma lived without the disease getting worse.
Genentech chief medical officer and head of global product development Dr Hal Barron said; "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."
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, according to the company.
The data for final overall survival, the other co-primary endpoint, is expected to be announced in 2013.