Thierry Facon, Shaji K Kumar, Robert Z Orlowski, Nizar Bahlis, Philippe Moreau, Hartmut Goldschmidt, Supratik Basu, Cyrille Hulin, Sonja Zweegman, Katja Weisel, Aurore Perrot, Caroline Jacquet, Noopur Raje, Salomon Manier, Ajai Chari, Markus Hansson, Mohamad Mohty, Michel Delforge, Torben Plesner, Gordon Cook, Xavier Leleu, Hang Quach, Christopher P Venner, Mourad Tiab, Margaret Macro, Laurent Frenzel, George Wang, Huiling Pei, Kasey Bolyard, Robin Carson, Fredrik Borgsten, Saad Z Usmani
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.