Eisai Presents Data on Benefits of Long-Term Administration of Dual-Acting Lecanemab at the 17th Clinical Trials for Alzheimer's Disease (CTAD) Conference
Eisai and Biogen presented new findings for lecanemab-irmb (LEQEMBI), their Alzheimer's disease treatment, at the CTAD Conference. Three-year continuous treatment data showed significant benefits: 59% of patients with no/low tau accumulation showed improvement or no decline, while 46% of patients with low amyloid levels improved or had no decline on cognitive scales. A new testing method revealed strong correlation between protofibrils and neurodegenerative biomarkers. Long-term safety profile remained consistent with no new concerns, with most ARIA events occurring in the first six months of treatment.
Eisai e Biogen hanno presentato nuove scoperte riguardanti lecanemab-irmb (LEQEMBI), il loro trattamento per l'Alzheimer, durante la Conferenza CTAD. I dati del trattamento continuo di tre anni hanno mostrato benefici significativi: il 59% dei pazienti con accumulo di tau assente o limitato ha mostrato miglioramenti o nessun declino, mentre il 46% dei pazienti con bassi livelli di amiloide ha registrato miglioramenti o nessun declino nelle scale cognitive. Un nuovo metodo di test ha rivelato una forte correlazione tra protofibrille e biomarcatori neurodegenerativi. Il profilo di sicurezza a lungo termine è rimasto coerente, senza nuove preoccupazioni, con la maggior parte degli eventi ARIA che si sono verificati nei primi sei mesi di trattamento.
Eisai y Biogen presentaron nuevos hallazgos sobre lecanemab-irmb (LEQEMBI), su tratamiento para la enfermedad de Alzheimer, en la Conferencia CTAD. Los datos de un tratamiento continuo de tres años mostraron beneficios significativos: el 59% de los pacientes con acumulación baja o nula de tau mostró mejoría o ningún deterioro, mientras que el 46% de los pacientes con bajos niveles de amiloide mejoró o no sufrió deterioro en las escalas cognitivas. Un nuevo método de prueba reveló una fuerte correlación entre protofibrillas y biomarcadores neurodegenerativos. El perfil de seguridad a largo plazo se mantuvo consistente sin nuevas preocupaciones, siendo la mayoría de los eventos ARIA ocurridos en los primeros seis meses de tratamiento.
에사이와 바이오젠은 CTAD 컨퍼런스에서 그들의 알츠하이머병 치료제 레카네맙-irmb (LEQEMBI)에 대한 새로운 발견을 발표했습니다. 3년간의 지속적인 치료 데이터는 중요한 이점을 보여주었습니다: 타우 축적이 없는/낮은 환자의 59%가 개선되거나 감소하지 않았고, 낮은 아밀로이드 수치를 가진 환자의 46%가 인지 척도에서 개선 또는 감소가 없었습니다. 새로운 시험 방법은 프로토피브릴과 신경퇴행성 바이오마커 간의 강한 상관관계를 나타냈습니다. 장기 안전성 프로필은 새로운 우려 없이 일관되게 유지되었고, 대부분의 ARIA 사건은 치료의 첫 6개월 동안 발생했습니다.
Eisai et Biogen ont présenté de nouvelles découvertes concernant lecanemab-irmb (LEQEMBI), leur traitement de la maladie d'Alzheimer, lors de la conférence CTAD. Les données d'un traitement continu de trois ans ont montré des avantages significatifs : 59% des patients sans ou avec peu d'accumulation de tau ont montré une amélioration ou aucun déclin, tandis que 46% des patients ayant de faibles niveaux d'amyloïde se sont améliorés ou n'ont montré aucun déclin sur les échelles cognitives. Une nouvelle méthode de test a révélé une forte corrélation entre les protofibrilles et les biomarqueurs neurodégénératifs. Le profil de sécurité à long terme est resté cohérent, sans nouvelles inquiétudes, la plupart des événements ARIA se produisant au cours des six premiers mois de traitement.
Eisai und Biogen haben neue Ergebnisse zu lecanemab-irmb (LEQEMBI), ihrer Behandlung für Alzheimer, auf der CTAD-Konferenz vorgestellt. Die Daten zur dreijährigen kontinuierlichen Behandlung zeigten signifikante Vorteile: 59% der Patienten mit keiner oder geringer Tau-Akkumulation zeigten Verbesserungen oder keinen Rückgang, während 46% der Patienten mit niedrigen Amyloidwerten in kognitiven Skalen besser abschnitten oder keinen Rückgang erlitten. Eine neue Testmethode ergab eine starke Korrelation zwischen Protofibrillen und neurodegenerativen Biomarkern. Das langfristige Sicherheitsprofil blieb konsistent ohne neue Bedenken, wobei die meisten ARIA-Ereignisse in den ersten sechs Monaten der Behandlung auftraten.
- 59% of patients with no/low tau showed improvement or no decline after 3 years of treatment
- 46% of low-amyloid patients improved or had no decline on cognitive scales
- 30% reduction in risk of disease progression
- No new safety concerns observed in 3-year treatment period
- High patient satisfaction reported in 5-year treatment survey
- Higher ARIA incidence in ApoE4 homozygote patients
- 0.7% rate of serious intracerebral hemorrhage reported
- 26% of patients experienced infusion-related reactions
Insights
The latest data from Eisai and Biogen's lecanemab (LEQEMBI) trials shows promising long-term efficacy in early Alzheimer's disease treatment. Key findings include
The data reveals significant benefits for patients with low amyloid levels at baseline, with
A new testing method has established stronger correlations between protofibrils and neurodegenerative biomarkers, supporting lecanemab's mechanism of targeting toxic protofibrils. The completion of patient enrollment in the AHEAD 3-45 study for preclinical AD also marks an important milestone in expanding treatment to earlier disease stages.
-New testing method highlights link between protofibrils and biomarkers for neurodegeneration-
-Patient and caregiver perspectives on five-year treatment with lecanemab -
- Utilization of blood biomarkers to predict brain amyloid accumulation in AHEAD study of preclinical AD-
Benefits of Continued Treatment with Lecanemab for People with Early AD
In July 2024 at the Alzheimer's Association International Conference (AAIC) 2024, results from the open-label long-term extension study (OLE) following the core study of the lecanemab Phase 3 Clarity AD study were presented, showing that the mean change from baseline in CDR-SB (global cognitive and functional scale) in the lecanemab treated group relative to the placebo group was -0.45 at 18 months, and at 36 months, this expanded to -0.95 compared to a prespecified natural history** cohort of AD. There was a
Clarity AD data presented at CTAD expand on these initial results to include additional measurements resulting from three (3) years of continuous lecanemab treatment in patients with low levels of amyloid accumulation in the brain at baseline (less than 60 Centiloids: low amyloid). These data show that
No new safety findings were observed with continued lecanemab treatment over three (3) years. Most amyloid-related imaging abnormalities (ARIA) occurred in the first six (6) months of treatment. After the first six (6) months, ARIA rates were low and similar to ARIA rates on placebo during the placebo-controlled period. With regards to the incidence of ARIA by ApoEε4 status during the continuous treatment, the incidence was higher in ApoE4 homozygotes than in heterozygotes or non-carriers, but rates of new ARIA were decreased after the completion of the 18 months core study as treatment continued, regardless of ApoEε4 status.2
Correlation between Protofibrils and Biomarkers for Neurodegenerative Disease in the AD Brain
Dual-acting lecanemab is the only early AD treatment available to support neuronal function by clearing the highly toxic protofibrils that continue to cause neuronal injury and death even after plaques have been cleared from the brain. Protofibrils accumulate early in the AD brain and lead to nerve cell function loss, abnormal nerve processes, inflammation, and memory loss. In non-clinical studies, antibodies against protofibrils prevented protofibril-mediated neuronal dysfunction and memory loss.
Accurately quantifying the amount of protofibrils in human cerebrospinal fluid (CSF) has been challenging due to their low concentration. As such, a new measurement method was developed by researchers at Eisai to accurately quantify protofibrils in CSF.
Utilizing this new method of measurement, the amount of protofibrils in AD CSF correlated more strongly with neurodegenerative disease biomarkers (CSF total tau and neurogranin) than with CSF Aβ42, a biomarker associated with Aβ plaques accumulation, indicating that protofibrils are closely related to synaptic dysfunction. Furthermore, it was observed that protofibrils, unlike plaques, are diffusible. These results suggest that protofibrils induce synaptic dysfunction, playing an important role in neurodegeneration in AD brains.3
Lecanemab Treatment for Early AD: Insights from Long-Term
Dr. Marwan Noel Sabbagh, Moreno Family Chair for Alzheimer's Research and Vice Chairman for Research and Professor, Department of Neurology, Barrow Neurological Institute, presented outcomes of an analysis of the use of lecanemab treatment between January 6, 2023, and July 30, 2024, based on payment claims data from the Komodo Research Database, a medical database in the
Dr. David
No new long-term safety findings were observed in these multi-year studies.5
Progress in the AHEAD 3-45 Study: Improving Screening Eligibility Using Blood Biomarkers and Completing Patient Enrollment
AHEAD 3-45 is a Phase 3 clinical study for individuals with preclinical AD, meaning they are clinically unimpaired but have intermediate or elevated levels of amyloid in their brains. In the study, blood tests, cognitive function tests (PACC-5***), amyloid PET, MRI, and tau PET were used for screening. Based on the amount of Aβ accumulation in the brain as determined by amyloid PET, subjects were assigned to two (2) trials with different dose settings: the A3 trial, for those with borderline Aβ levels in the brain, and the A45 trial, for those with positive Aβ levels in the brain.6
Screening with blood biomarker tests was important to improve eligibility for amyloid PET testing in subjects without cognitive impairment. Using plasma Aβ42/40 ratio and p-tau217/tau217 ratio in the initial screening reduced screening failure on amyloid PET from more than
Enrollment for the AHEAD 3-45 study was completed in October 2024.
Lifetime Achievement Award Presented to Professor Lannfelt
Professor Emeritus Lars Lannfelt of Uppsala University received the CTAD Lifetime Achievement Award in recognition of his pioneering work in scientific discovery and drug development in AD. As part of this award ceremony, he delivered a keynote speech outlining the discovery of the arctic mutation in familial AD, its application to therapeutic strategies targeting protofibrils for AD treatment, and the development of lecanemab.
Eisai serves as the lead for lecanemab's development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.
*Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be the most toxic form of Aβ, having a primary role in the cognitive decline of this progressive, debilitating condition.7 Protofibrils cause injury to neurons in the brain which, in turn, can negatively impact cognitive function through multiple mechanisms, not only increasing the development of insoluble Aβ plaques but also increasing direct damage to brain cell membranes and the connections that transmit signals between nerve cells or nerve cells and other cells. It is believed the reduction of protofibrils may prevent the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction.8
**ADNI is a clinical research project launched in 2005 to develop methods to predict the onset of AD and to confirm the effectiveness of treatments. The ADNI observational cohort was pre-specified and used during the design of Clarity AD. The cohort represents the exact population of those in Clarity AD study; matched ADNI participants show similar degree of decline to placebo group out to 18 months.
***PACC-5 is a composite measure that provides a highly sensitive measure of changes in cognitive function in individuals with preclinical AD.
Please see full Prescribing Information for LEQEMBI, including Boxed WARNING.
LEQEMBI® [(lecanemab-irmb) 100 mg/mL injection for intravenous use] is indicated for the treatment of Alzheimer's disease (AD). Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.
IMPORTANT SAFETY INFORMATION
WARNING: AMYLOID-RELATED IMAGING ABNORMALITIES (ARIA) |
|
CONTRAINDICATION
LEQEMBI is contraindicated in patients with serious hypersensitivity to lecanemab-irmb or to any of the excipients of LEQEMBI. Reactions have included angioedema and anaphylaxis.
WARNINGS AND PRECAUTIONS
AMYLOID-RELATED IMAGING ABNORMALITIES
LEQEMBI can cause ARIA-E and ARIA-H, which can occur together. ARIA-E can be observed on magnetic resonance imaging (MRI) as brain edema or sulcal effusions and ARIA-H as microhemorrhage and superficial siderosis. ARIA can occur spontaneously in patients with AD. With this class of medications, ARIA-H generally occurs in association with ARIA-E. Reported ARIA symptoms may include headache, confusion, visual changes, dizziness, nausea, and gait difficulty. Focal neurologic deficits may also occur. Symptoms usually resolve over time.
Incidence of ARIA
Symptomatic ARIA occurred in
ApoE ε4 Carrier Status and Risk of ARIA
Of the patients taking LEQEMBI,
Radiographic Findings
The majority of ARIA-E radiographic events occurred within the first 7 doses, although ARIA can occur at any time, and patients can have >1 episode. Maximum radiographic severity of ARIA-E with LEQEMBI was mild in
Intracerebral Hemorrhage
Intracerebral hemorrhage >1 cm in diameter was reported in
Concomitant Antithrombotic Medication:
In Clarity AD, baseline use of antithrombotic medication (aspirin, other antiplatelets, or anticoagulants) was allowed if the patient was on a stable dose. The majority of exposures to antithrombotic medications were to aspirin. Antithrombotic medications did not increase the risk of ARIA with LEQEMBI. The incidence of intracerebral hemorrhage was
Other Risk Factors for Intracerebral Hemorrhage:
Patients were excluded from enrollment in Clarity AD for findings on neuroimaging that indicated an increased risk for intracerebral hemorrhage. These included findings suggestive of cerebral amyloid angiopathy (prior cerebral hemorrhage >1 cm in greatest diameter, >4 microhemorrhages, superficial siderosis, vasogenic edema) or other lesions (aneurysm, vascular malformation). The presence of an ApoE ε4 allele is also associated with cerebral amyloid angiopathy. Caution should be exercised when considering the use of LEQEMBI in patients with factors that indicate an increased risk for intracerebral hemorrhage and in patients who need to be on anticoagulant therapy.
ARIA Monitoring and Dose Management Guidelines
Obtain a recent baseline brain MRI prior to initiating treatment with LEQEMBI and prior to the 5th, 7th, and 14th infusions. Enhanced clinical vigilance for ARIA is recommended during the first 14 weeks of treatment with LEQEMBI. Depending on ARIA-E and ARIA-H clinical symptoms and radiographic severity, use clinical judgment when considering whether to continue dosing or to temporarily or permanently discontinue LEQEMBI. If a patient experiences ARIA symptoms, clinical evaluation should be performed, including MRI if indicated. If ARIA is observed on MRI, careful clinical evaluation should be performed prior to continuing treatment.
HYPERSENSITIVITY REACTIONS
Hypersensitivity reactions, including angioedema, bronchospasm, and anaphylaxis, have occurred with LEQEMBI. Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity reaction and initiate appropriate therapy.
INFUSION-RELATED REACTIONS (IRRs)
IRRs were observed—LEQEMBI:
In the event of an IRR, the infusion rate may be reduced or the infusion may be discontinued and appropriate therapy initiated as clinically indicated. Consider prophylactic treatment prior to future infusions with antihistamines, acetaminophen, nonsteroidal anti-inflammatory drugs, or corticosteroids.
ADVERSE REACTIONS
The most common adverse reaction leading to discontinuation of LEQEMBI was ARIA-H microhemorrhages that led to discontinuation in
The most common adverse reactions reported in ≥
[Notes to editors]
1. About lecanemab (LEQEMBI®)
Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). Lecanemab is approved in the
LEQEMBI's approvals in these countries were based on Phase 3 data from Eisai's, global Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results. The primary endpoint was the global cognitive and functional scale, Clinical Dementia Rating Sum of Boxes (CDR-SB). In the Clarity AD clinical trial, treatment with lecanemab reduced clinical decline on CDR-SB by
In July 2024 Eisai presented 36-month data from the Phase 3 Clarity AD Open-Label Extension Study demonstrating that LEQEMBI-treated patients continued to show benefit at 36 months of treatment. In the 18-month core study of Clarity AD, there was a statistically significant difference in global cognition and function as measured by CDR-SB between the LEQEMBI and placebo groups. The separation in CDR-SB between the group that continued to receive LEQEMBI (early start group) and the group who switched from placebo to LEQEMBI (delayed start group) was maintained during the 6-month OLE following the core study. This indicates that similar disease trajectory for both early and delayed start groups occurred with LEQEMBI administration. The blood biomarker results (plasma Aβ42/40 ratio, ptau181, GFAP and NfL) showed improvement even after delayed initiation of treatment with LEQEMBI.
Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the
2. About the Collaboration between Eisai and Biogen for AD
Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.
3. About the Collaboration between Eisai and BioArctic for AD
Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody back-up was signed in May 2015.
4. About Eisai Co., Ltd.
Eisai's Corporate Concept is "to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides." Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.
In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners.
For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us on X, LinkedIn and Facebook. The website and social media channels are intended for audiences outside of the
5. About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients' lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.
The company routinely posts information that may be important to investors on its website at www.biogen.com. Follow Biogen on social media – Facebook, LinkedIn, X, YouTube.
Biogen Safe Harbor
This news release contains forward-looking statements, including about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof; the treatment of Alzheimer's disease; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs; including lecanemab; and risks and uncertainties associated with drug development and commercialization. These statements may be identified by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "possible," "potential," "will," "would" and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. You should not place undue reliance on these statements.
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation unexpected concerns that may arise from additional data, analysis or results obtained during clinical studies; the occurrence of adverse safety events; risks of unexpected costs or delays; the risk of other unexpected hurdles; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen's drug candidates; including lecanemab; actual timing and content of submissions to and decisions made by the regulatory authorities regarding lecanemab; uncertainty of success in the development and potential commercialization of the medicine; failure to protect and enforce Biogen's data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; and third party collaboration risks, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen's expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen's most recent annual or quarterly report and in other reports Biogen has filed with the
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