Additional Phase III data for Avastin in glioblastoma

Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit reported additional data showing that Avastin bevacizumab plus temozolomide and radiation led to a median progression-free survival (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) in the Phase III AVAglio trial to treat newly diagnosed glioblastoma. However, interim data from the trial showed that Avastin plus temozolomide and radiation did not significantly improve overall survival (OS), a co-primary endpoint, vs. placebo plus temozolomide and radiation (HR=0.89, p=0.2135). Final OS data are expected next year. The double-blind, international trial enrolled 921 patients. Data were presented at the Society for Neuro-Oncology meeting in Washington.

The humanized mAb against VEGF 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. ...