Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Lecanemab IV, BAN2401
Lecanemab · 3 trials · 4 indications
PACC5(5 components):Free/cued selective reminding test:number of words recalled without cuing/with cuing(0\[worst\]-96\[best recall\]);Delayed Paragraph Recall test: recall of 1 short story(25 bits information),immediately after reading and again after delay of 30 minutes (0\[worst\]-25\[best recall\]);Digit-symbol substitution test: Participant uses a key to fill in blank squares as fast as possible in 90 seconds(0\[none\]-91\[best performance\]);Mini Mental State Score:to evaluate orientation,memory,attention,concentration,naming,repetition,comprehension and ability to create sentence,to copy 2 overlapping pentagons, scored as number of correctly completed items(0\[worse\]-30\[perfect performance\]);Category fluency task: participants generate words in 60 second belonging to a semantic category(total score:number of appropriate words generated per task, higher values indicate better performance).
A TEAE is defined as an adverse event (AE) that emerges during treatment or within 30 days of the last dose of study drug, having been absent at pretreatment (Baseline) or reemerges during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the adverse event was continuous. Number of participants with TEAEs (serious and non-serious adverse events) will be reported based on their regular measurement of vital signs, safety assessments of laboratory tests, antidrug antibody assessments, suicidality assessments, magnetic resonance imaging and electrocardiogram parameter values.
The ADCOMS is a composite score that comprises 4/14 items from the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), 2 items from the Mini Mental State Examination (MMSE), and all items from the Clinical Dementia Rating (CDR). Composite score is derived from the variables from the 12 items, and ranges from 0 to 1.97, where higher score means greater impairment. Change from baseline was analyzed using Bayesian analysis. Data presented are posterior mean and posterior standard deviation.
A TEAE is defined as an AE that emerged during treatment or within 90 days following the last dose of study drug, having been absent at pretreatment (Baseline) or reemerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous. A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening (that is, the participant is at immediate risk of death from the adverse event as it occurs, this does not include an event that, has it occurred in a more severe form or is allowed to continue, might have cause death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect (in the child of a participant who is exposed to the study drug).
A TEAE is defined as an AE that emerged during treatment or within 30 days following the last dose of study drug, having been absent at pretreatment (Baseline) or reemerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous. A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening (that is, the participant is at immediate risk of death from the adverse event as it occurs, this does not include an event that, has it occurred in a more severe form or is allowed to continue, might have cause death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect (in the child of a participant who is exposed to the study drug).
| Arm | Type | Description |
|---|---|---|
| A45 Trial: Lecanemab 5 mg/kg + 10 mg/kg (Core Study) | EXPERIMENTAL | Participants will receive lecanemab 5 milligram per kilogram (mg/kg), administered as intravenous (IV) infusion, every two weeks from Week 0 to 6, then 10 mg/kg, administered as IV infusion, every two weeks from Week 8 to 94, and 10 mg/kg, administered as IV infusion, every four weeks from Week 96 to 216 in core study. |
| A45 Trial: Placebo (Core Study) | PLACEBO_COMPARATOR | Participants will receive placebo (0.9 percent \[%\] sodium chloride solution), administered as IV infusion, every two weeks from Week 0 to 94, then every four weeks from Week 96 to 216. |
| A3 Trial: Lecanemab 5 mg/kg + 10 mg/kg (Core Study) | EXPERIMENTAL | Participants will receive lecanemab 5 mg/kg, administered as IV infusion, every four weeks from Week 0 to 4, then 10 mg/kg, administered as IV infusion, every four weeks from Week 8 to 216 in core study. |
| A3 Trial: Placebo (Core Study) | PLACEBO_COMPARATOR | Participants will receive placebo (0.9% sodium chloride solution), administered as IV infusion, every four weeks from Week 0 to 216. |
| A3 and A45 Trial: Lecanemab 10 mg/kg (Extension Phase) | EXPERIMENTAL | Participants (from either A3 or A45 Trial) progressing to early Alzheimer's disease (EAD) during the core study (progressors) will receive lecanemab 10 mg/kg, administered as IV infusion, every two weeks after transition to the extension phase for at least 216 weeks from randomization in the core study. Participants completing the core study (completers) will enter extension phase and will receive lecanemab 5 mg/kg for initial 4 doses, than 10 mg/kg, administered as IV infusion, every two weeks for up to 96 weeks in extension phase. |
| Core Study: Lecanemab 10 milligram per kilogram (mg/kg) biweekly | EXPERIMENTAL | - |
| Core Study: Placebo | PLACEBO_COMPARATOR | - |
| Extension Phase: Lecanemab 10 mg/kg biweekly | EXPERIMENTAL | - |
| Extension Phase: Lecanemab Subcutaneous (SC) Injection Dose 1 | EXPERIMENTAL | This will include approximately 40 de novo participants (those that did not participate in the core study) with EAD. |
| Extension Phase: Lecanemab SC Injection Dose 2 | EXPERIMENTAL | - |
| Extension Phase: Lecanemab SC Injection Dose 3 | EXPERIMENTAL | - |
| Extension Phase: Lecanemab SC Injection Dose 4 | EXPERIMENTAL | - |
| Extension Phase: Lecanemab 10 mg/kg IV Infusion Once Every 4 Weeks (Q4W) | EXPERIMENTAL | - |
| Extension Phase B | EXPERIMENTAL | Participants will receive Lecanemab 10 mg/kg IV infusion Q2W, or Q4W, or Dose 3, or Dose 4, SC injection, weekly. |
| Core Study: Lecanemab 2.5 mg/kg biweekly | EXPERIMENTAL | 2.5 mg/kg biweekly |
| Core Study: Lecanemab 5.0 mg/kg biweekly | EXPERIMENTAL | 5.0 mg/kg biweekly |
| Core Study: Lecanemab 10 mg/kg biweekly | EXPERIMENTAL | 10 mg/kg biweekly |
| Core Study: Lecanemab 5.0 mg/kg monthly | EXPERIMENTAL | 5.0 mg/kg monthly |
| Core Study: Lecanemab 10 mg/kg monthly | EXPERIMENTAL | 10 mg/kg monthly |
| Core Study: Lecanemab-matched Placebo | PLACEBO_COMPARATOR | Matching placebo biweekly |
| Extension Phase: Lecanemab 10 mg/kg | EXPERIMENTAL | All participants who fulfill Extension Phase inclusion and exclusion criteria will have the option to participate in the Extension Phase to receive lecanemab 10 mg/kg biweekly for up to 60 months or until the benefit-to-risk ratio from treatment with lecanemab is no longer considered favorable, whichever comes first. Additionally, participants who have received Extension Phase treatment for at least 18 months may opt to enter the dosing regimen substudy during which they will receive either lecanemab 10 mg/kg once every 4 weeks (Q4W) or once every 3 months (Q3M). |
| Name | Type | Description |
|---|---|---|
| Lecanemab | DRUG | IV infusion. |
| Placebo | DRUG | IV infusion. |
| Lecanemab IV | DRUG | Administered as IV infusion. |
| Lecanemab SC | DRUG | Administered weekly as a SC injection. |
| Lecanemab 2.5 mg/kg | DRUG | 2.5 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion |
| Lecanemab 5.0 mg/kg | DRUG | 5.0 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion |
| Lecanemab 10 mg/kg | DRUG | 10 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion. |
Inclusion criteria: Participants must meet all of the following criteria to be included in this study: 1. Male or female, age 55 to 80 years inclusive at the time of informed consent, with a plasma biomarker result that is predictive of intermediate or elevated brain amyloid at Screening or known ...
Lecanemab is being developed for Alzheimer's disease, including early Alzheimer's disease and preclinical Alzheimer's disease. It is an investigational monoclonal antibody studied in patients with elevated amyloid, and it has received FDA designations including Priority Review, Fast Track, and Accelerated Approval.
Lecanemab targets APP, the amyloid precursor protein, and is classified as an inhibitor. By binding to its target, it is designed to interfere with the amyloid pathway implicated in Alzheimer's disease. The drug is a monoclonal antibody administered intravenously.
Lecanemab is being developed by Biogen Inc., which trades on the Nasdaq under the ticker BIIB. Biogen is the company responsible for the clinical development program of this monoclonal antibody across Alzheimer's disease indications.
Lecanemab is in Phase 2 of clinical development according to its overall program status, though individual trials have reached Phase 3. It is an investigational therapy and has received FDA designations of Priority Review, Fast Track, and Accelerated Approval.
Lecanemab has been studied in several trials, including the Phase 3 AHEAD 3-45 study (NCT04468659) in preclinical Alzheimer's disease, the Phase 3 study NCT03887455 in early Alzheimer's disease, and the completed Phase 2 study NCT01767311. These trials enrolled participants with Alzheimer's disease or its early stages.