Phase 3 Trial Update of Avastin Plus Radiation and Temozolomide for Newly Diagnosed Glioblastoma

Genentech announced positive results from its Phase 3 study of Avastin (bevacizumab) plus radiation and temozolomide (Temodar; Merck & Co., Inc.) chemotherapy in patients with newly diagnosed glioblastoma.

AVAglio was a randomized, double-blind, placebo controlled trial that assessed the efficacy and safety of Avastin in combination with radiation and temozolomide chemotherapy following surgery or biopsy in patients with newly diagnosed glioblastoma. 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.

In the study, Avastin in combination with radiation and temozolamide chemotherapy significantly improved progression-free survival compared to those treated with radiation and temozolamide chemotherapy plus placebo. Data for final overall survival are expected in 2013.

Avastin is an angiogenesis inhibitor that binds directly to the VEGF protein and interferes with the tumor's blood supply. It prevents the tumor from interacting with receptors on the blood vessel cells. The tumor blood supply is thought to be critical to a tumor's ability to grow and spread in the body (metastasize).

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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