Daratumumab, lenalidomide, and dexamethasone in transplant-ineligible newly diagnosed multiple myeloma: MAIA final survival analysis.

In previous analyses of MAIA, daratumumab plus lenalidomide/dexamethasone (D-Rd) significantly improved progression-free survival and overall survival (OS) versus lenalidomide/dexamethasone (Rd) in transplant-ineligible newly diagnosed multiple myeloma (NDMM). We report results on long-term OS and subsequent antimyeloma therapies from the MAIA final analysis. A protocol amendment (July 20, 2021) led to a long-term extension of MAIA, during which patients were followed for OS. A total of 737 patients were randomized to D-Rd (n = 368) or Rd (n = 369). At a median follow-up of 89.3 months (range, 0.0-102.2; interquartile range, 85.3-93.0), median OS was 90.3 months (95% confidence interval [CI], 80.8-not estimable [NE]) with D-Rd versus 64.1 months (56.0-70.8) with Rd (hazard ratio [HR], 0.67; 95% CI, 0.55-0.82); estimated 7-year OS rates were 53.1% (95% CI, 47.8-58.2) and 39.3% (34.1-44.5), respectively. Median time to subsequent antimyeloma treatment was not reached (95% CI, 84.1-NE) for D-Rd versus 42.4 months (33.5-50.6) for Rd (HR, 0.51; 95% CI, 0.41-0.63; P < 0.0001). Death due to adverse events occurred in 84 patients (D-Rd, n = 44/364 [12%]; Rd, n = 40/365 [11%]). With >7 years of follow-up, D-Rd demonstrated a new benchmark for median OS (7.5 years) in transplant-ineligible NDMM, further supporting frontline D-Rd use to maximize survival.