Avastin bevacizumab: Additional Phase III data

Additional data from the double-blind, international Phase III AVAglio trial in 921 patients with newly diagnosed glioblastoma showed that Avastin plus temozolomide and radiation led to a median PFS, a co-primary endpoint, of 10.6 months vs. 6.2 months for placebo plus temozolomide and radiation (HR=0.64, p<0.0001). However, interim data from the trial showed that Avastin plus temozolomide and radiation did not significantly improve OS, a co-primary endpoint, vs. placebo plus temozolomide and radiation (HR=0.89, p=0.2135). Final OS data are expected in 2013. On secondary endpoints, the Avastin arm led to a 1-year survival rate of 72% vs. 66% for placebo (p=0.052). Patients in the Avastin arm received 10 mg/kg IV Avastin every 2 weeks plus temozolomide and radiation for 6 weeks followed by a 4-week break. Patients then received maintenance therapy with Avastin plus temozolomide for up to 6 cycles followed by Avastin monotherapy until disease progression. Data were presented at the Society for Neuro-Oncology meeting in Washington. In August, Genentech reported that AVAglio met the co-primary PFS endpoint (see BioCentury, Aug. 13).

Avastin has accelerated approval in the U.S. and is approved in over 30 countries worldwide to treat glioblastoma in patients with progressive disease following prior therapy. Genentech said it conducted AVAglio as part of a postmarketing commitment to FDA for Avastin in glioblastoma. Both Genentech and Roche declined to comment as to whether an OS benefit for Avastin needs to be shown for full approval, or if a PFS benefit is sufficient. ...