The results of the ANDROMEDA phase 3 study of SC DARA + CyBorD in patients with newly diagnosed AL amyloidosis, which were presented during the Late-Breaking abstract session at EHA25, suggest that the combination has the potential to become the new standard of care in this setting, with the addition of daratumumab to CyBorD resulting in deeper and more rapid haematological responses than CyBorD alone.
A complete haematological response was seen in 53% of patients treated with DARA-CyBorD vs 18% with CyBorD (P<0.0001) with a median time to response of 60 days vs 85 days, respectively. The complete response (CR) rate at 6 months was consistent with overall CR rate (50% DARA-CyBorD vs 14% CyBorD). Haematological CR rate was significantly higher in every subgroup with DARA-CyBorD, including patients with advanced cardiac disease, renal disease and t(11;14).
At median follow-up of 11.4 months, major organ deterioration (MOD)-PFS was improved with DARA-CyBorD vs CyBorD (HR, 0.58; P=0.0230), indicating that treatment with the daratumumab combination can substantially MOD, haematological progression or death compared to CyBorD alone. DARA-CyBorD was also associated with substantially improved event-free survival vs CyBorD.
The 6-month cardiac response rate was 42% for DARA-CyBorD and 22% for CyBorD (P=0.0029); 6-month renal response rate was 54% and 27%, respectively (P<0.0001).
The safety profile of DARA-CyBorD was consistent with the known profiles of DARA subcutaneous treatment and CyBorD. More deaths occurred in the DARA-CyBorD arm however treatment duration was much longer compared with the CyBorD arm (9.6 vs 5.3 months, respectively).
Overall, DARA-CyBorD was seen to significantly improve outcomes for patients with newly diagnosed ML amyloidosis with delayed major organ damage, haematological progression or death and improved organ response at 6-months.
SUBCUTANEOUS (SC) DARATUMUMAB (DARA) + CYCLOPHOSPHAMIDE, BORTEZOMIB, AND DEXAMETHASONE (CyBorD) IN PATIENTS WITH NEWLY DIAGNOSED LIGHT CHAIN (AL) AMYLOIDOSIS: PRIMARY RESULTS FROM THE PHASE 3 ANDROMEDA STUDY
Abstract LB2604 Oral presentation