Daratumumab–CyBorD Combo Tolerable, Effective in Newly Diagnosed AL Amyloidosis
In a study of patients with light chain (AL) amyloidosis, daratumumab plus cyclophosphamide, bortezomib, and dexamethasone (CyBorD) was shown to produce robust responses and was well-tolerated (Blood. 2020;136[1]:71-80.).
“Although no therapies are approved for [AL] amyloidosis, [CyBorD] is considered standard of care. Based on outcomes of daratumumab in multiple myeloma (MM), the phase 3 ANDROMEDA study…is evaluating daratumumab-CyBorD vs CyBorD in newly diagnosed AL amyloidosis,” wrote Giovanni Palladini, MD, PhD, Amyloidosis Research and Treatment Center, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia, Italy, and co-investigators.
A total of 28 patients with a median of 2 involved organs were enrolled in the safety run-in portion of the study by Dr Palladini et al. All patients received a median of 16 treatment cycles, including subcutaneous daratumumab (DARA SC) given weekly during cycles 1 to 2, every 2 weeks during cycles 3 to 6, and every 4 weeks thereafter for up to 2 years, and CyBorD administered weekly for 6 cycles.
According to the findings, treatment-emergent adverse events were consistent with those observed for DARA SC in multiple myeloma and CyBorD. One patient had grade 1 infusion-related reactions. There were no grade 5 treatment-emergent adverse events, but 5 deaths were reported, including 3 that occurred posttransplant.
The overall hematologic response rate was 96%, with a complete hematologic response in 15 (54%) patients. At 1, 3, and 6 months, 20, 22, and 17 patients, respectively, had at least a partial response.
“Renal response occurred in 6 of 16, 7 of 15, and 10 of 15 patients, and cardiac response occurred in 6 of 16, 6 of 13, and 8 of 13 patients at 3, 6, and 12 months, respectively. Hepatic response occurred in 2 of 3 patients at 12 months,” Dr Palladini and colleagues wrote.
“Daratumumab-CyBorD was well tolerated, with no new safety concerns versus the intravenous formulation, and demonstrated robust hematologic and organ responses,” they concluded.—Hina M. Porcelli
