Light chain (AL) amyloidosis is a rare and potentially fatal multi-system disorder that occurs when bone marrow produces abnormal pieces of antibodies called light chains, which clump together to form a substance called amyloid.
These clumps of amyloid are deposited in tissues and vital organs and interfere with normal organ function.
People who have been diagnosed with this disease are in urgent need of new therapies, as there are currently no approved treatment options.
Chemotherapy- based combinations are commonly used in AL amyloidosis, but more effective treatments are needed.
Daratumumab is the first and only subcutaneous CD38-directed antibody approved globally to treat multiple myeloma.
The Phase 3 ANDROMEDA study evaluated subcutaneous (SC) daratumumab in combination with cyclophosphamide, bortezomib, and dexamethasone (D-CyBorD) compared to CyBorD alone in newly diagnosed patients with AL amyloidosis.
Results showed that the primary endpoint, haematologic complete response rate, was 53% for D-CyBorD compared to 18% for CyBorD.
The six-month organ response rate was nearly doubled for patients treated with D-CyBorD versus CyBorD, for both cardiac (42% vs. 22%) and renal (54% vs. 27%) responses.
The D-CyBorD combination had an acceptable safety profile consistent with what has been previously observed for daratumumab SC or CyBorD alone.
The ANDROMEDA study suggests that daratumumab SC may be a promising treatment for newly diagnosed patients with AL amyloidosis who are in urgent need of new treatment options.
Watch our interview with Prof Efstathios Kastritis about this study here.
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