Avastin misses OS endpoint in glioblastoma Phase III
The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) said Avastin bevacizumab plus temozolomide and radiation missed the co-primary endpoint of improving median overall survival (OS) vs. placebo plus temozolomide and radiation (16.8 vs. 16.7 months, p=0.0987) in the 921-patient Phase III AVAglio trial to treat newly diagnosed glioblastoma. On secondary endpoints, median progression-free survival (PFS) as assessed by an independent review was 8.4 months in the Avastin arm vs. 4.3 months in the placebo arm (p<0.0001). Data were presented at the American Society of Clinical Oncology meeting in Chicago.
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, which conducted AVAglio as part of a postmarketing commitment to FDA, said it will discuss the data with regulatory authorities but declined to comment as to whether Avastin needs to show an OS benefit for full approval, or if a PFS benefit is sufficient. ...