On 20 March, at the AD/PD 2026 International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders, during a symposium on “Abeta targeting therapies in AD: Progress and perspectives”, Eli Lilly presented three-year amyloid trajectory data from TRAILBLAZER-ALZ 2 (NCT04437511).
Eli Lilly’s Kisunla (donanemab) is an anti-amyloid beta (Aβ) monoclonal antibody (mAb) approved for the treatment of patients with mild cognitive impairment (MCI) or mild Alzheimer’s disease. It was the second anti-Aβ mAb to enter the Alzheimer’s disease market following Eisai/Biogen’s Leqembi (lecanemab).
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As a key differentiator, Eli Lilly is positioning Kisunla as the only finite disease-modifying therapy (DMT) for Alzheimer’s disease, as treatment with Kisunla is stopped once amyloid clearance has been achieved, as seen on a positron emission tomography (PET) scan. For Leqembi treatment, Eisai and Biogen are utilising a continuous maintenance treatment strategy.
The three-year data TRAILBLAZER-ALZ 2 presented at AD/PD 2026 focused on the amyloid-plaque trajectories in patients who had received Kisunla in the randomised, placebo-controlled part of the study and had achieved amyloid clearance and thus completed their treatment with Kisunla by week 52.
In these patients, an amyloid level below 24.1 centiloids (CL), the cut-off used in TRAILBLAZER-ALZ 2 for completing treatment with Kisunla, was generally maintained throughout their off-treatment period to 154 weeks. At week 154, the mean amyloid level was 10.99CL, and 82.6% of patients had maintained levels below 24.1CL. There was also a significant association between lower levels of amyloid clearance at week 52 and lower amyloid levels at week 154. The data correlated with an exposure-response model developed by Eli Lilly that simulated a re-accumulation rate of 2.4CL/year, which is similar to the rate of amyloid accumulation in untreated individuals.
Three-year data was also presented for patients who had received Kisunla in the randomised, placebo-controlled part of the study but had not achieved amyloid clearance by week 76 and therefore continued with Kisunla treatment in the long-term extension (LTE) period of the study. In this group of patients, the percentage of patients with an amyloid level below 24.1CL increased throughout the LTE period, reaching 56.8% at week 154.
This data shows that for patients who achieve early amyloid clearance within one year of initiating Kisunla, stopping treatment does not result in rapid amyloid accumulation; and that for patients who do not achieve early amyloid clearance, continuing to take Kisunla can still result in amyloid clearance. As expected, patients with lower baseline amyloid levels were more likely to reach the treatment completion criteria by week 52, and those with higher baseline levels were less likely to achieve treatment completion criteria at 76 weeks.
Lilly is looking to further increase confidence in its finite treatment strategy with TRAILBLAZER-ALZ 2 Addendum 11, which is ongoing to characterise amyloid re-accumulation for an additional three years. Further research into whether Kisunla should be reinitiated once amyloid levels rise above 24.1CL, what that would look like in practice in terms of frequency of amyloid monitoring, and how this correlates to disease progression, is still needed to provide a truly long-term picture of what Alzheimer’s disease treatment and management should look like with Kisunla.
As uptake of the drug increases globally, real-world use of Lilly’s Kisunla outside of clinical trials will also help consolidate its treatment strategy and how it correlates to clinical impact, not just the pathological clearance and slow re-accumulation of amyloid. Additionally, real-world data for long-term Kisunla and Leqembi treatment strategies beyond just a couple of years will be crucial for allowing the different treatment strategies to be evaluated.
