BioCentury
ARTICLE | Clinical News

Solanezumab: Phase III data

August 27, 2012 7:00 AM UTC

Data from the 18-month, double-blind, international Phase III EXPEDITION1 and EXPEDITION2 trials in over 2,050 patients with mild to moderate AD combined showed that 400 mg IV solanezumab given every 4 weeks missed the primary endpoints vs. placebo. Specifically, data from EXPEDITION1 showed that solanezumab missed the co-primary endpoints of improving cognitive (ADAS-Cog11) and functional (ADCS-ADL) scores from baseline to week 80 vs. placebo. A pre-specified secondary subgroup analysis showed that solanezumab did significantly improve ADAS-Cog11 scores vs. placebo in patients with mild AD. Based on the data, Eli Lilly modified the statistical analysis plan for EXPEDITION2 prior to database lock to specify a single primary endpoint of ADAS-Cog14 scores from baseline to week 80 in patients with mild AD. However, solanezumab missed the single primary endpoint vs. placebo in EXPEDITION2.

A pre-specified secondary analysis of pooled data from both trials showed that solanezumab significantly slowed cognitive decline vs. placebo in the overall study population. Additionally, a pre-specified secondary subgroup analysis of the pooled data showed that solanezumab significantly slowed cognitive decline vs. placebo in patients with mild AD, but not in patients with moderate AD. Mild AD was defined as a baseline MMSE score of 20-26 points and moderate AD was defined as a baseline MMSE score of 16-19 points. ...