Results from the long-term extension of the Phase III TRAILBLAZER-ALZ 2 trial (NCT04437511) showed sustained benefits with early Kisunla treatment, including reduced risk of disease progression and high rates of amyloid clearance in early Alzheimer disease.
Image Credit: Adobe Stock Images/Orawan
Results from the long-term extension (LTE) of the Phase III TRAILBLAZER-ALZ 2 trial (NCT04437511) showed that Eli Lilly’s Kisunla (donanemab-azbt) continued to slow cognitive and functional decline in patients with early symptomatic Alzheimer disease (AD) over a three-year period. According to the company, results demonstrated that patients who began treatment earlier experienced greater clinical benefit.1
"The TRAILBLAZER-ALZ 2 long-term extension reaffirms that Kisunla delivered sustained clinical benefit that continued to increase over three years and a consistent safety profile," said Mark Mintun, MD, group VP, neuroscience research & development, Eli Lilly and Company, in a press release. "Participants continued to show meaningful outcomes, reinforcing the long-term value of early intervention."
The LTE results come shortly after the FDA approved a label update for Kisunla. Earlier this month, the agency authorized a new titration dosing schedule aimed at reducing the incidence of amyloid-related imaging abnormalities with edema/effusion in patients with early symptomatic AD, including those with mild cognitive impairment or mild dementia and confirmed amyloid pathology. This decision was based on data from the TRAILBLAZER-ALZ 2 trial.3
Kisunla was first approved by the FDA in July 2024 as the first amyloid plaque-targeting therapy that allows for stopping treatment upon plaque removal in patients with early symptomatic AD.4
According to a 2024 study published in the National Center for Biotechnology Information, an estimated 6.9 million people in the United States 65 years of age and older are currently living with AD. The number is expected to grow to approximately 13.8 million by 2060, barring the development of medical breakthroughs. Currently, it is the fifth leading cause of death among Americans aged 65 years and older.5
"Kisunla demonstrated very meaningful results for people with early symptomatic Alzheimer's disease, who urgently need effective treatment options,: said Anne White, EVP, president, Lilly Neuroscience, Eli Lilly and Company, in a 2024 press release. “We know these medicines have the greatest potential benefit when people are treated earlier in their disease, and we are working hard in partnership with others to improve detection and diagnosis. Our deepest thanks to the patients and their loved ones for participating in our clinical programs and to Lilly scientists and collaborators persevering over decades of research. Each year, more and more people are at risk for this disease, and we are determined to make life better for them."4
References
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