Genentech, a member of the Roche Group, announced results from the Phase 3 AVAglio study; the study evaluated Avastin (bevacizumab) in combination with radiation and temozolomide (Temodar; Merck) chemotherapy in patients with newly diagnosed glioblastoma. Avastin is an angiogenesis inhibitor that binds directly to the VEGF protein.
AVAglio was a randomized, 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. Patients were randomized to receive either:
• Avastin plus radiation and temozolomide chemotherapy for six weeks followed by a four-week break. Patients then received Avastin and temozolomide for up to six cycles, followed by Avastin alone until disease progression.
• Radiation, temozolomide and placebo for six weeks followed by a four-week break. Patients then received temozolomide and placebo for up to six cycles, followed by placebo until disease progression.
The 36% reduction in the risk of disease worsening or death that was observed can also be referred to as a 56% improvement in progression-free survival (PFS) (HR=0.64; P<0.0001). A 4.4 month improvement in median PFS was observed when patients received Avastin in combination with radiation and chemotherapy vs. those who received radiation and chemotherapy plus placebo (10.6 months vs. 6.2 months, respectively).
Avastin is currently indicated as monotherapy to treat glioblastoma in patients with progressive disease following prior therapy. Avastin is also indicated for metastatic colorectal carcinoma, in combination with 5-FU-based chemotherapy; first-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer (NSCLC), in combination with carboplatin and paclitaxel; and metastatic renal cell carcinoma (mRCC) in combination with interferon alfa.
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