Multinational phase 3 trial of addition of daratumumab to VRd in NDMM patients eligible for autologous stem cell transplantion

The multinational phase 3 PERSEUS trial randomized patients with newly diagnosed multiple myeloma (NDMM) eligible for autologous stem cell transplantation (autoSCT) 1:1 to subcutaneous daratumumab (D) plus bortezomib, lenalidomide, and dexamethasone (VRd) or VRd alone. Primary endpoint was progression-free survival. At a median follow-up of 47.5 months, progression-free survivalwas significantly improved with D-VRd versus VRd. Overall rates of complete response or better (87,9% versus 70.1%; p<0.0001) and MRD negativity (75.2% versus 47.5%; p<0.0001) also were better with D-VRd compared with VRd. For D-VRd and VRd, serious TEAEs occurred in 57.0% versus 49.3% of patients, and TEAEs leading ot treatment discontinuation in 8.8% versus 21.3%. The authors conclude that among transplant-eligible NDMM patients, addition of subcutaneous D to VRd was associated with significant improvement of PFS and increased depth of response.