Understanding the Safety Profile of Lecanamab: Marwan Sabbagh, MD, FAAN

WATCH TIME: 3 minutes

"The overall ARIA-E incidence rate was around 12%. If you broke it down by APOE genotype, in the non-carriers, it was only 5%. That’s amazing. The treated group had almost 900 people, so that’s a very low incidence rate."

On January 6, 2023, the FDA is expected to make a decision on Eisai’s lecanemab, an investigational agent being assessed for patients with early Alzheimer disease (AD). Lecanemab, formerly known as BAN2401, is a humanized monoclonal antibody that eliminates toxic amyloid-ß protofibrils. Submitted under the accelerated approval pathway, the application was supported by data from the phase 2b proof-of-concept trial, known as Study 201 (NCT01767311) along with supplementary data from the phase 3 Clarity AD study (NCT03887455).

At the 2022 Clinical Trials on Alzheimer (CTAD) conference, held November 29 to December 2, in San Francisco, California, several in-depth analyses were presented on Clarity AD, including a talk on safety of the agent given by Marwan Sabbagh, MD, FAAN. The study, which featured 1795 people with early AD, had a 12.5% occurrence rate of amyloid-related imaging abnormalities-edema (ARIA-E) compared with 1.7% of those on placebo, including symptomatic ARIA-E rates of 2.8% and 0.0% in the respective groups. Sabbagh, a behavioral neurologist in the Alzheimer’s and Memory Disorders Program at Barrow Neurological Institute, believes these numbers are promising, especially considering high levels of ARIA have been a main cause for previously failed agents.

At CTAD 2022, Sabbagh sat down with NeurologyLive^® to discuss the safety profile of the agent, why it appears so promising, and the level of concern for ARIA. Additionally, he discussed how clinicians within the field can appropriately treat and manage patients with AD with the agent, if approved.

Click here for more coverage of CTAD 2022.

REFERENCE
1. Irizarry M, van Dyck C, Sabbagh M, Bateman R, Cohen S. Clarity AD: A phase 3 placebo-controlled, double-blind, parallel-group, 18-month study evaluating lecanemab in early Alzheimer disease. Presented at: CTAD Conference, November 29-Dec 2.