The neurologist and assistant professor at the University of Toronto provided insight on positive topline findings from the phase 3 Clarity AD study of lecanemab in early Alzheimer disease. [WATCH TIME: 4 minutes]
WATCH TIME: 4 minutes
"I was very pleased and encouraged by these results. They’re strong, they’re consistent, and they tell a story that is not easy to poke holes into. And we need that in our field."
The 2021 approval of aducanumab (Aduhelm; Biogen) opened the door for several other Alzheimer disease (AD) agents in the pipeline, including lecanemab (BAN2401; Biogen/Eisai), a humanized monoclonal antibody. In July 2022, the FDA accepted the biologics license application for lecanemab under the accelerated approval pathway and granted priority review to the application. At the time, the FDA agreed that the results of the pivotal, phase 3 Clarity AD (NCT03887455) trial could serve as a confirmatory study to verify the benefit of the agent, which currently has a PDUFA date set for January 6, 2023.
Ahead of the 15th Clinical Trials on Alzheimer’s Disease Congress, planned for November 29 to December 2, 2022, Eisai and Biogen announced topline findings from Clarity AD, which showed that lecanemab met its primary and secondary end points with highly statistically significant results. All told, treatment with lecanemab resulted in a change of –0.45 (P = .00005), or 27% reduction, in global cognitive and functional scale, as assessed by the Clinical Dementia Rating-Sum of Boxes. The incidence of amyloid-related imaging abnormalities-edema/effusion, an adverse event associated with anti-amyloid antibodies, was 12.5% in the lecanemab group and 0.0% in the placebo group.
To learn more about the new findings and their clinical implications, NeurologyLive® sat down with study investigator Sharon Cohen, MD. Cohen, a neurologist and assistant professor at the University of Toronto, provided her reaction to the findings, as well as described the most notable data points and surprises of which the clinical community should be aware.