ASH 2024 | Updated results of the ANDROMEDA trial: daratumumab + CyBorD versus CyBorD alone in AL amyloidosis

It is a great pleasure and delight to be at the 66th annual American Society of Hematology meeting in San Diego. It is an exciting meeting for the treatment of AL amyloidosis. We are presenting an updated analysis of the ANDROMEDA clinical trial, and this is the final analysis. And as a reminder, the ANDROMEDA clinical trial is a clinical trial of patients with newly diagnosed AL amyloidosis. And this is a Phase III randomized global international multi-center clinical trial that led to the approval of daratumumab, bortezomib, cyclophosphamide, dexamethasone, or VCd, in the treatment of newly diagnosed patients with AL amyloidosis. At this meeting, this trial is going to be presented as the final analysis with respect to major organ deterioration progression-free survival as well as overall survival. As a reminder, 388 patients with newly diagnosed AL amyloidosis were enrolled on this trial, and the hematologic complete response at a median follow-up of 61 months was achieved by 59.5 percent of patients treated with Dara-VCd compared to 19% of patients treated with VCd alone. Moreover, the major organ deterioration progression-free survival defined as death, organ failure, or hematologic progression as a composite endpoint, and overall survival were achieved in more patients treated with Dara-VCd than VCd with a hazard ratio of 0.4 and 0.6, respectively. Patients who were treated with Dara-VCd also achieved a complete cardiac response in 40% of patients. The median duration of hematologic CR was not reached with a median follow-up of 61 months. So this is really going to be a game changer and is going to become a standard of care for patients with newly diagnosed AL amyloidosis; treatment will be Dara-VCd.

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