Final survival analysis of the phase III MAIA trial: DRd vs Rd for NDMM

Results from a long-term follow-up analysis of the randomized, open-label phase III MAIA trial (NCT02252172), evaluating daratumumab + lenalidomide + dexamethasone (DRd; n = 368) vs lenalidomide + dexamethasone (Rd; n = 369) in patients with newly diagnosed multiple myeloma (NDMM) who were ineligible for high-dose chemotherapy and autologous hematopoietic stem cell transplant (auto-HSCT) due to age (≥65 years) or comorbidities, were published in Leukemia by Facon et al. This analysis focused on the secondary endpoints of overall survival (OS) and time to subsequent antimyeloma treatment.

Key data: At a median follow-up of 89.3 months, median OS was 90.3 months with DRd vs 64.1 months with Rd (hazard ratio [HR], 0.67; 95% confidence interval [CI], 0.55–0.82); estimated 7-year OS rates were 53.1% with DRd and 39.3% with Rd. Median time to subsequent antimyeloma treatment was not reached (NR) with DRd vs 42.4 months with Rd (HR, 0.51; 95% CI, 0.41–0.63; p < 0.0001). Death due to adverse events (AEs) occurred in 12% of patients in the DRd group and 11% of patients in the Rd group; most of these events were considered unrelated to study treatment.

Key learning: In this final analysis of the MAIA trial, median OS was reached for the first time in the DRd group at a median follow-up of >7 years, and DRd continued to demonstrate a clinical survival benefit vs Rd alone in patients with NDMM who were transplant-ineligible.