Phase III study of Avastin (Genentech/Roche) in Brain Cancer patients fails to reach primary endpoints

A Phase III trial of Avastin (bevacizumab), from Genentech/Roche, shows the drug failed to reach its primary endpoints - increase overall survival (OS) or statistically significant progression-free survival (PFS) - for glioblastoma patients in the frontline setting. The randomized, double-blind, placebo-controlled study registered 978 and enrolled 637 patients, respectively, all of whom were newly diagnosed with glioblastoma. Participants underwent surgery, received standard of care of chemoradiation, and were randomized to receive either bevacizumab or placebo.

The researchers found no difference in OS between the bevacizumab and placebo arms, 15.7 and 16.1 months, respectively. PFS did not reach the pre-set level statistical significance, although longer, in those taking bevacizumab upfront (10.7 months), compared to in those receiving placebo (7.3 months). Bevacizumab was associated with a higher rate of toxicities, including hypertension, bleeding, deep vein thrombosis and pulmonary embolism, and gastrointestinal perforation. Those on the therapy also experienced increase rates of symptom burden and neurocognitive decline, as well decreased quality of life, compared to those on placebo. Results were presented at ASCO.