Earlier this month, Roche announced topline results from its Phase III GRADUATE studies of gantenerumab, an investigational anti-amyloid beta antibody, for the treatment of early Alzheimer’s disease (AD). According to their analyses, neither GRADUATE I or the identically-designed GRADUATE II study reached their primary endpoint of slowing clinical decline on the CDR-SB global cognitive and functional scale.
As a consequence of these results, Roche has decided to discontinue most of its global clinical trials of gantenerumab, including the GRADUATION, OpenRoAD, PostGraduate and SKYLINE trials. The company announced this decision following presentation of topline results from GRADUATE I and II at the Clinical Trials in Alzheimer’s Disease (CTAD) conference in San Francisco.
The GRADUATE trials recruited 1,965 participants with mild cognitive impairment due to Alzheimer’s disease (AD) or mild AD dementia, who received fortnightly subcutaneous injections of either gantenerumab or placebo. Participants receiving gantenerumab experienced a relative reduction in clinical decline of 8% in GRADUATE I and 6% in GRADUATE II compared with placebo, however those results were not statistically significant. Additionally, the company revealed that the level of beta-amyloid removal by gantenerumab was lower than expected.
Roche worked rapidly to release these topline data only three weeks after unblinding, a move lauded by experts at CTAD. The company is now looking at new technologies to shuttle higher levels of gantenerumab into the brain, with results of Phase Ib/IIa trials expected in 2024.
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