|
| Friday, 12 November 2021, 14:31 HKT/SGT | |
| |  | |
Source: Eisai | |
|
|
|
|
| Consistency of Efficacy Assessments Evaluated Across Various Statistical Methods |
TOKYO and CAMBRIDGE, Mass., Nov 12, 2021 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. announced today results of sensitivity analyses evaluating the consistency of lecanemab efficacy results across multiple statistical models in patients with Mild Cognitive Impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD). This presentation was made by Eisai at the 2021 Clinical Trials on Alzheimer's Disease (CTAD) conference, November 9-12, 2021 in Boston, Massachusetts and virtually.
In September 2021, Eisai initiated a rolling submission of a Biologics License Application (BLA) for lecanemab, an investigational anti-amyloid beta protofibril antibody, for the treatment of early AD, to the U.S. Food and Drug Administration (FDA) under the accelerated approval pathway.
Study 201, a multicenter, double-blind, placebo-controlled, Phase 2b trial conducted in 856 patients with early AD, evaluated key efficacy assessments, including clinical change on the Alzheimer's Disease Composite Score (ADCOMS) at the primary endpoint of 12 months and at select key secondary endpoints, Clinical Dementia Rating-Sum-of-Boxes (CDR-SB) and Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) at 18 months. Six sensitivity analyses across four statistical models (mixed model for repeated measures, disease progression model, natural cubic spline model, and quadratic mixed model) showed consistent positive lecanemab treatment effects for ADCOMS, CDR-SB and ADAS-Cog14 at 18 months.
The primary endpoint was Bayesian analysis of 12-month clinical change on ADCOMS with the goal to identify the most efficacious dose (ED90 dose). Primary analysis was super-superiority over placebo by ≥25%: goal was 80% probability of >/=25% reduction in decline versus placebo. Study achieved the goal of identifying smallest dose that achieved ≥90% of maximum treatment effect (10 mg/kg biweekly), i.e., the ED90 dose. At 12 months, ED90 dose had 64% probability of being super-superior to placebo by 25% reduction. At 12 months, ED90 dose had 98% probability superior to placebo. Consistent treatment effect was observed at 18 months for ADCOMS (29% to 37%), CDR-SB (26.5% to 35%), and ADAS-Cog (47% to 56%), with separation from placebo observed by six months for the top dose (10mg/kg biweekly) across all analyses.
"In Study 201, lecanemab showed robust clearance of brain amyloid and slowing of clinical decline across several clinical and biomarker endpoints. This sensitivity analysis shows lecanemab clinical efficacy results across statistical models are consistent, reliable and further enhances our confidence in the clinical potential of this investigational therapy," said Michael Irizarry, M.D., Vice President, Deputy Chief Clinical Officer, Neurology Business Group, Eisai Inc. "Through our comprehensive research program, we will continue to advance the understanding of how this anti-amyloid beta protofibril antibody may play a role in the treatment of early and preclinical AD. In March 2021, Eisai completed enrollment of 1,795 patients with early Alzheimer's disease in our confirmatory Phase 3 Clarity AD clinical study. The Phase 3 clinical study, AHEAD 3-45, is currently exploring lecanemab's safety and efficacy in individuals with preclinical AD."
This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agent will successfully complete clinical development or gain health authority approval.
For more information, visit https://www.eisai.com/news/2021/news202187.html.
Topic: Press release summary
Source: Eisai
Sectors: BioTech
http://www.acnnewswire.com
From the Asia Corporate News Network
Copyright © 2026 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.
|
|
|
|
|
|
|
| Eisai |
| Apr 21, 2026 19:52 HKT/SGT |
|
Merck & Co., Inc., Rahway, NJ, USA and Eisai Provide Update on Phase 3 LITESPARK-012 Trial Evaluating First-Line Combination Treatments for Certain Patients With Advanced Renal Cell Carcinoma (RCC) |
| Mar 27, 2026 19:14 HKT/SGT |
|
Application Submitted for LENVIMA(R) (lenvatinib) in Japan Seeking Approval of Additional Dosage and Administration for Combination with WELIREG(R) (belzutifan) for Renal Cell Carcinoma that has Progressed After Chemotherapy |
| Mar 27, 2026 17:19 HKT/SGT |
|
Eisai and Nuvation Bio Announce Marketing Authorisation Application for Taletrectinib for the Treatment of Advanced ROS1-Positive Non-Small Cell Lung Cancer Validated by the European Medicines Agency |
| Mar 23, 2026 10:19 HKT/SGT |
|
Results from Real-World, Long-Term Treatment Persistence with LEQEMBI(R) (lecanemab-irmb) in the United States Presented at AD/PD(TM) 2026 |
| Mar 19, 2026 09:54 HKT/SGT |
|
Eisai: Regarding Discontinuation of Administration of "Tazverik(R) Tablets 200mg" (tazemetostat hydrobromide) |
| Mar 17, 2026 18:49 HKT/SGT |
|
Eisai Established the Global Capability Centre in Visakhapatnam, India, to Standardize Global IT Infrastructure Operations and Digital Transformation |
| Mar 12, 2026 16:21 HKT/SGT |
|
Eisai Launches Awareness Campaign on Importance of Sleep Through "Pokemon Sleep" Collaboration |
| Mar 11, 2026 11:07 HKT/SGT |
|
Eisai to Present the Latest Data on Long-Term, Real-World Treatment with Lecanemab at the AD/PD(TM) 2026 Annual Meeting |
| Mar 2, 2026 08:49 HKT/SGT |
|
WELIREG(R) (belzutifan) Plus LENVIMA(R) (lenvatinib) Reduced the Risk of Disease Progression or Death by 30% Compared to Cabozantinib in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma (RCC) |
| Feb 16, 2026 13:03 HKT/SGT |
|
Ministry of Health, Labour and Welfare Grants Orphan Drug Designation in Japan to Novel Orexin Receptor Agonist E2086 for Narcolepsy |
| More news >> |
 |
|
|
|
