Since January 2022, lecanemab has been incorporated as the backbone anti-amyloid therapy in the Tau NexGen clinical study for Dominantly Inherited Alzheimer's Disease (DIAD), conducted by the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) at Washington University School of Medicine in St Louis, MO.
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Eisai Presents Real-World Lecanemab Data at AD/PD 2025 Confirming Phase 3 Clinical Trial Findings
In addition to support for phase 3 CLARITY AD findings, new evidence was presented supporting lecanemab safety and efficacy in ApoE ε4 carriers and non-carriers.
Real-world clinical evidence presented at the 2025 International Conference on Alzheimer's and Parkinson's Diseases (AD/PD) demonstrates that lecanemab use in clinical practice aligns with FDA-approved prescribing recommendations, with patient adherence patterns suggesting that neither MRI monitoring requirements nor adverse events significantly interfere with dosing schedules for the anti-amyloid antibody (AAA).
The findings from research conducted by Eisai, were presented along with data that support the AAA's competitive safety profile.
Michael Rosenbloom, MD, a behavioral neurologist from the University of Washington in Seattle, presented the real world outcomes during an oral session at the conference held in Vienna, Austria, from April 1-5. The data provides the first substantial post-approval validation that the anti-amyloid beta monoclonal antibody's real-world performance matches expectations set during clinical trials, according to a company statement from Eisai development partner BioArctic.
During a poster session, Linda Söderberg, PhD, principal scientist at BioArctic, presented research that confirms the high selectivity of lecanemab for toxic amyloid-beta (Aβ) protofibrils in the brains of individuals with AD. The data demonstrated that the AAA's limited binding to fibril structures in cerebral amyloid angiopathy may explain the relatively lower frequency of amyloid-related imaging abnormalities (ARIA) characterized by edema reported for lecanemab compared to some other anti-amyloid therapies, BioArctic said.
Additional presentations by Lutz Froelich, MD, PhD, professor of geriatric medicine at the University of Heidelberg, in Heidelberg, Germany, detailed efficacy and safety outcomes with lecanemab treatment specifically in participants with early Alzheimer disease from the phase 3 Clarity AD study who had different apolipoprotein E ε4 (ApoEε4) genotypes, ie, heterozygous carriers or noncarriers, according to a company statement. These findings formed the basis for recent regulatory decisions, including approval in the United Kingdom and the positive CHMP recommendation for EU approval. The data confirmed that the lecanemab effects in the UK and EMA proposed indicated populations were comparable to those seen in the overall Clarity AD trial population, though with lower risk of ARIA events.
Lecanemab, developed through a strategic research alliance between Eisai and BioArctic, is a humanized IgG1 monoclonal antibody that preferentially binds to both soluble Aβ aggregates (protofibrils) and insoluble Aβ plaques.
In January 2025, the FDA approved an intravenous maintenance dosing regimen for lecanemab that allows transitioning to 10 mg/kg once every 4 weeks after an 18-month initiation phase of bi-weekly dosing.2 Additionally, the FDA has accepted Eisai's Supplemental Biologics License Application for a subcutaneous autoinjector for weekly maintenance dosing, with a PDUFA action date set for August 31, 2025.3
Ongoing Clinical Research
The AHEAD 3-45 phase 3 clinical study,4 ongoing since July 2020, is investigating the potential efficacy of lecanemab in preclinical Alzheimer disease—targeting individuals who are clinically normal but show intermediate or elevated amyloid levels in their brains. The trial aims to determine whether early intervention with anti-amyloid therapy can prevent or delay clinical symptom onset.
Lecanemab has been approved in multiple countries including the US, Japan, China, and the United Kingdom. The European Commission is currently proceeding with the decision-making process for marketing authorization following February's reaffirmation of a positive opinion from the Committee for Medicinal Products for Human Use, according to the company statement.
References
1. Exidavnemab and lecanemab data presented at the 2025 AD/PD™ congress. News release. BioArctic AB. April 7, 2025. Accessed April 8, 2025. https://www.bioarctic.com/en/exidavnemab-and-lecanemab-data-presented-at-the-2025-ad-pd-congress/
2. Halsey G. FDA approves monthly IV maintenance dosing of lecanemab for adults with early Alzheimer dementia: A first in long-term disease management. Patient Care. January 26, 2025. https://www.patientcareonline.com/view/fda-approves-monthly-iv-maintenance-dosing-of-lecanemab-for-adults-with-early-alzheimer-dementia-a-first-in-long-term-disease-management
3. Halsey G. The FDA accepts Eisai BLA for lecanemab subcutaneous maintenance dosing in adults with Alzheimer disease. Patient Care. January 14, 2025. https://www.patientcareonline.com/view/the-fda-accepts-eisai-bla-for-lecanemab-subcutaneous-maintenance-dosing-in-adults-with-alzheimer-disease
4. Meglio M. Lecanemab will be evaluated in preclinical Alzhemier disease with novel study design. Patient Care Online. August 13, 2024. https://www.patientcareonline.com/view/lecanemab-will-be-evaluated-in-preclinical-alzheimer-disease-with-novel-study-design
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