Stephen Salloway, MD, Brown University, Butler Hospital, Providence, RI, discusses the new developments in amyloid-targeting antibodies for Alzheimer’s disease. Currently, there are three medicines in development that have progressed significantly: lecanemab, donanemab, and gantenerumab. Lecanemab is under review by the FDA for accelerated approval, with announcements on its status to occur in early 2023. Data from the Phase III clinical trials of gantenerumab and lecanemab will be reported in November 2023. This interview took place at the Alzheimer’s Association International Conference (AAIC) 2022 in San Diego, CA.
Transcript (edited for clarity)
The next big thing people should pay attention to is that in the next year, there are going to be readouts from three other medicines that lower amyloid plaques: gantenerumab, donanemab, and lecanemab. And those first results will come out in the fall and going into next year. And those are going to be really informative about if we’re able to move forward with these new disease modifying treatments...
The next big thing people should pay attention to is that in the next year, there are going to be readouts from three other medicines that lower amyloid plaques: gantenerumab, donanemab, and lecanemab. And those first results will come out in the fall and going into next year. And those are going to be really informative about if we’re able to move forward with these new disease modifying treatments. The update is that one is under review at the FDA, lecanemab for accelerated approval, and that submission has already taken place. And the FDA has to announce their decision by January so that will be coming. And then both gantenerumab and lecanemab have announced that their trials will be ending, and they’ll be reporting results in October and November. So that’ll be really important. And then there’ll be other results coming out as well, soon after that from other trials. So it’s going to be a busy time in terms of clinical trial results for Alzheimer’s.
Dr. Salloway was the co-chair of the Investigator Steering Committee for the Aducanumab phase 3 program and he served as a site PI for the aducanumab and lecanemab phase 3 studies, the donanemab phase 2 trial and he was the Project Arm Leader for gantenerumab in DIAN-TU. He has received consulting income from Biogen, Lilly, Roche, Genentech, Bolden, Amylyx, Prothena and Eisai. He has no stock or royalties related to any medication in development. Dr. Salloway serves on the planning committee for the National Disease Modifying Treatment and Diagnostic Registry Work Group and he is a member of the ADRD Therapeutics Work Group. He is the first author for the report of ARIA in aducanumab phase 3 (Salloway, JAMA Neurology, 2022), the report of gantenerumab and solanezumab in DIAN-TU (Salloway, Nature Medicine, 2021). He is a co-author on the report of the donanemab phase 2 trial (Mintun, NEJM, 2021) and the Aducanumab Appropriate Use Recommendations (Cummings, Journal of the Prevention of Alzheimer’s Disease, 2021).