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AAIC 2021 | Lecanemab: Phase II open-label extension results

Chad Swanson, PhD, Eisai Inc., describes results from the ongoing open-label extension (OLE) of the BAN2401-G000-201 study (NCT01767311), investigating lecanemab for patients with early Alzheimer’s disease (AD). The OLE commenced once the Phase II study was complete, allowing subjects from the core study to be brought back for treatment following a gap period, the average of which was 24 months. At AAIC 2021, Dr Swanson presented data showing that 147 subjects previously treated with lecanemab in the core study were identified as meeting early AD criteria at OLE baseline, whilst 24 subjects were identified as having progressed. Analyses demonstrated that whilst subjects who were still in early stages of AD at OLE baseline had experienced disease progression during the gap period, the treatment difference seen between lecanemab and placebo groups was maintained, suggesting potential disease-modifying effects of lecanemab. In the OLE study, not only did clinical decline in subjects newly treated with lecanemab plateau relative to controls, but also patients who had previously received lecanemab in the core Phase II study showed a reduction in clinical decline. Furthermore, changes in plasma Aβ42/40 ratio were shown for the first time to correlate with the response to lecanemab treatment seen in both the core and OLE studies. This interview took place during the Alzheimer’s Association International Conference (AAIC), 2021.