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Abstract Details

Clinical Profile for Lecanemab Subcutaneous Formulation for Treatment Initiation and Maintenance in Early Alzheimer’s Disease (AD)
Aging, Dementia, and Behavioral Neurology
S1 - New Perspectives on Alzheimer's Therapeutics (1:36 PM-1:48 PM)
004

To report on clinical trial results evaluating the clinical profile of subcutaneous lecanemab formulation for maintenance and treatment initiation.
Lecanemab, a humanized IgG1 monoclonal antibody, has demonstrated consistent slowing of clinical decline and reduction of amyloid in individuals with early AD. To improve patient convenience, a subcutaneous autoinjector formulation of lecanemab was recently approved as maintenance therapy (360 mg weekly) by the FDA and a 500 mg subcutaneous dose has been submitted to the FDA for treatment initiation.
The subcutaneous development program evaluated a range of doses and delivery methods (e.g. vial/syringe and autoinjector) to establish the subcutaneous doses for initiation and maintenance with comparable exposure to intravenous dosing. Clarity AD phase 3 substudy evaluations included safety outcomes and pharmacokinetics and established bioequivalence between subcutaneous 500 mg dose and the intravenous dose (10 mg/kg biweekly). Exposure-response modeling was conducted to characterize relationships between lecanemab exposure and efficacy, amyloid PET, as well as incidence of ARIA-E.

Weekly subcutaneous lecanemab has a safety and tolerability profile consistent with intravenous lecanemab, except for lower rate (<2%) and severity of systemic injection-related reactions compared to the rate (~26%) and severity of infusion-related reactions with intravenous lecanemab. Exposure-response modeling demonstrated similar efficacy and amyloid reduction with bioequivalent exposures. The incidence of ARIA-E was correlated with lecanemab serum concentrations and modeling accurately predicted ARIA-E rate for each APOE4 genotype following subcutaneous and intravenous dosing. The ARIA-E incidence following a 500 mg subcutaneous autoinjector dose is predicted to be similar to that of 10mg/kg biweekly intravenous lecanemab for initiation.
Weekly subcutaneous lecanemab at doses of 500 mg and 360 mg has a clinical profile that compares favorably to the approved 10mg/kg biweekly and monthly intravenous doses, respectively, but with low rate of systemic injection reaction relative to intravenous infusion-related reactions.
Authors/Disclosures
Sharon Cohen, MD
PRESENTER 		The institution of Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eisai. The institution of Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen.
Steven M. Hersch, MD, PhD (Eisai Inc.) Dr. Hersch has received personal compensation for serving as an employee of Eisai Inc.. Dr. Hersch has stock in Voyager Therapeutics. The institution of an immediate family member of Dr. Hersch has received research support from NIH. Dr. Hersch has received intellectual property interests from a discovery or technology relating to health care.
Natalia Penner, PhD Dr. Penner has received personal compensation for serving as an employee of eisai. Dr. Penner has received personal compensation for serving as an employee of Zentalis. Dr. Penner has received personal compensation for serving as an employee of Biogen. Dr. Penner has stock in Biogen.
Pratik Bhagunde, PhD Dr. Bhagunde has received personal compensation for serving as an employee of Eisai.
Larisa Reyderman Larisa Reyderman has nothing to disclose.
Anna Patten (Eisai) No disclosure on file
Shobha Dhadda Shobha Dhadda has received personal compensation for serving as an employee of Eisai Inc.
Michael C. Irizarry, MD (Eisai, Inc) Dr. Irizarry has received personal compensation for serving as an employee of Eisai, Inc..
Lynn D. Kramer, MD, FAAN (Eisai Inc.) Dr. Kramer has received personal compensation for serving as an employee of Eisai Inc. Dr. Kramer has received personal compensation in the range of $1,000,000+ for serving as an officer or member of the Board of Directors for Eisai Co., Ltd..