Roche and Genentech reported positive data from a Phase III trial of Avastin (bevacizumab) in combination with radiation therapy and temozolomide chemotherapy in people with newly diagnosed glioblastoma. The anti-angiogenic therapy is already approved in various markets for treating glioblastoma either as monotherapy or in combination with irinotecan in patients whose disease has progressed after prior treatment.
The newly reported Phase III AVAglio study assessed Avastin in addition to radiation and tomozolomide in patients with newly diagnosed glioblastoma who have undergone surgery or biopsy. Data showed that addition of VEGF-blocking antibody significantly increased progression free survival (PFS). Overall survival data (the co-primary endpoint with PFS) are expected during 2013. Roche says it will discuss the data with regulatory authorities including FDA and the EC’s EMEA.
In addition to its existing glioblastoma indication, Avastin is approved in Europe for the treatment of advanced breast cancer and colorectal, non-small cell lung, kidney, and ovarian cancers. In the U.S. Avastin has had its breast cancer approval revoked on risk/benefit grounds, but is also approved for treating colorectal, non-small cell lung, and kidney cancers.