Eli Lilly has been hitting the headlines with the latest data release on donanemab in Alzheimer’s disease (AD).

The company has released the full results from the Phase III TRAILBLAZER-ALZ 2 study at the 2023 Alzheimer’s Association International Conference (AAIC).

The newly released pre-specified subpopulation analysis of participants with low-medium levels of tau based on the clinical stage demonstrated a greater benefit of donanemab in those at earlier stages of AD. Tau is a small protein that builds up in the brains of patients with AD.

Donanemab slowed decline by 60% on the integrated Alzheimer’s Disease Rating Scale (iADRS) and 46% on the Clinical Dementia Rating-Sum of Boxes (CDR-SB) in patients with mild cognitive impairment.

In the same tau level subgroup, donanemab showed a greater benefit in patients under the age of 75. In this patient population, the drug slowed decline by 48% on iARDS and 45% on CDR-SB. Patients aged 75 and above achieved a decline of 25% on iARDS and 29% on CDR-SB.

The overall treatment effect continued to increase throughout the trial and the largest differences compared to placebo were seen at 18 months.

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Donanemab also delayed disease progression in patients with an earlier pathological stage of the disease and low-medium tau. In the treatment arm, 47% had no disease progression at one year on the CDR-SB assessment compared to 29% in the placebo cohort. On average, treated patients had an additional 7.5 months before disease progression.

Safety overview

Eli Lilly also reported additional data on safety, detailing that the incidence of amyloid-related imaging abnormalities (ARIA) and infusion-related reactions was consistent with previous results.

The most commonly observed ARIAs are temporary swelling in one or more areas of the brain (ARIA-E), microhaemorrhages or superficial siderosis (ARIA-H).

ARIA-E was observed in 24% of patients treated with donanemab, with 1.5% experiencing serious ARIA-E. As seen in previous trials, rates of ARIA were the highest in patients who are homozygous for ApoE4. The risk of ARIA is increased in patients with higher amyloid levels at baseline.

Eli Lilly advises managing these risks with careful observation, MRI monitoring and appropriate actions if ARIA is detected in a patient.

Next regulatory steps

Eli Lilly completed its submissions for traditional approval to the US Food and Drug Administration (FDA) in Q2 2023, with regulatory action expected by the end of this year.

The company is also filing submissions to other global regulatory agencies, with the majority of applications to be completed by the end of the year.

Earlier this year, Eli Lilly failed to gain accelerated approval for donanemab from the FDA. The agency requested to see data showing at least 100 patients who received a minimum of 12 months of continued treatment. The initial application was based on a Phase II trial that enrolled 272 patients. However, many of these patients were treated for six months.