Lilly Shares Positive Donanemab Data in First Active Comparator Study in Early Symptomatic Alzheimer's Disease
- Brain amyloid clearance (<24.1 Centiloids) was achieved in 37.9% of donanemab-treated participants compared with 1.6% of Aduhelm® (aducanumab-avwa)-treated patients at 6 months
- Donanemab reduced brain amyloid plaque levels vs. baseline by 65.2% compared with 17.0% for Aduhelm® at 6 months
"The purpose of this first ever active comparator trial of amyloid lowering agents was to answer important questions about potential differences in amyloid plaque reduction," said
In the co-primary outcomes, brain amyloid plaque clearance, defined as achieving brain amyloid plaque levels of <24.1 Centiloids, was achieved in 37.9% of donanemab-treated participants (25 of 66) compared with 1.6% of Aduhelm-treated patients (1 of 64) at 6 months; in the intermediate tau subpopulation, 38.5% of donanemab-treated participants (10 of 26) reached brain amyloid clearance compared with 3.8% of Aduhelm-treated participants (1 of 26) by 6 months. In a key secondary outcome, donanemab reduced brain amyloid levels vs. baseline by 65.2% compared with 17.0% for Aduhelm at 6 months. In an exploratory outcome, donanemab, but not aducanumab-avwa, treatment significantly reduced plasma P-tau217 at 6 months compared to baseline.
The safety profile of both treatments was consistent with their previously published studies. ARIA was the most common treatment emergent adverse event in both groups. In the aducanumab-avwa group, the incidence of total ARIA was 26.1% with 4.3% being symptomatic. In the donanemab group, the incidence of total ARIA was 25.4% with 2.8% being symptomatic. For both treatments, all symptomatic cases were related to ARIA-E.
"It is encouraging to see that donanemab produced significant reduction of amyloid build up in the brain and P-tau in the blood after 6 months. This suggests that this treatment modified the biology of Alzheimer's disease early on in treatment," said
TRAILBLAZER-ALZ 4 is ongoing and will have 12-month and 18-month secondary analyses. The study is one of five studies that comprise the clinical program to evaluate the efficacy and safety of donanemab. In August,
About TRAILBLAZER-ALZ 4 Study
TRAILBLAZER-ALZ 4 (LY3002813) is a multicenter, randomized, open-label Phase 3 study of that enrolled 148 patients aged 50 to 85 with early symptomatic AD who met entry criteria including a Clinical Dementia Rating (CDR)-Global Score of 0.5 or 1 and gradual and progressive change in memory function for more than six months, among other criteria. Donanemab and Aduhelm are administered via intravenous infusions every four weeks for up to 18 months. Donanemab is administered until evidence of plaque clearance via positron emission tomography (PET) at 6, 12, or 18 months. Aduhelm is administered through the duration of the study according to its approved label. The studies' co-primary endpoints are superiority on, as measured by PET scan: the percentage of participants who reach complete amyloid plaque clearance and the percentage of participants who reach complete amyloid plaque clearance in the intermediate tau subpopulation at 6 months.
About Alzheimer's Disease
Alzheimer's disease is a fatal illness that causes progressive decline in memory and other aspects of cognition. Dementia due to Alzheimer's disease is the most common form of dementia, accounting for 60 to 80 percent of all cases1. There are currently over 55 million people living with dementia around the world, with numbers expected to increase to nearly 139 million by 20502. Over 10 million new cases of dementia are diagnosed each year worldwide, implying one new case every 3.2 seconds, and a significant increase in the caregiving burden placed on society and families. In the US alone, there was an increase of nearly 10 million new caregivers from 2015 to 20203. The current annual societal and economic cost of dementia is estimated at
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Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about
Alzheimer's Association. 2022 Alzheimer's Disease Facts and Figures. https://www.alz.org/media/Documents/alzheimers-facts-and-figures.pdf. Accessed May 12, 2022. Alzheimer's Disease International. Dementia Statistics. https://www.alzint.org/about/dementia-facts-figures/dementia-statistics/. Accessed May 12, 2022. AARP. 2020 Report: Caregiving in the U.S.https://www.aarp.org/content/dam/aarp/ppi/2020/05/full-report-caregiving-in-the-united-states.doi.10.26419-2Fppi.00103.001.pdf. Accessed May 12, 2022.
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