Multinational phase 3 trial of isatuximab, bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma

Bortezomib, lenalidomide, and dexamethasone (VRd) is a preferred first-line option for patients with newly diagnosed multiple myeloma (NDMM). The multinational phase 3 IMROZ trial evaluated addition of the anti-CD38 monoclonal antibody isatuximab to VRd among NDMM patients aged 18 to 80 years who were ineligible for transplantation. Patients were randomized to isatuximab-VRd or VRd alone. Primary endpoint was progression-free survival. The 60-month progression-free survival rate was 63.2% with isatuximab-VRd as compared with 45.2% with VRd alone (HR 0.60; p<0.001). The percentage of patients with a complete response or better was 74.7% versus 64.1% (p=0.01), and the percentage of patients with complete response and MRD-negative status was 55.5% versus 40.9% (p=0.003). No new safety signals were observed. The incidences of serious adverse events and discontinuation due to adverse events was similar in the two groups. The authors conclude that isatixumab-VRd was more effective than VRd as initial therapy in patients 18 to 80 years of age with NDMM who were ineligible to undergo transplantation.