Daratumumab plus lenalidomide and dexamethasone (D-Rd) versus lenalidomide and dexamethasone (Rd) alone in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM): updated analysis of the phase 3 Maia study

摘要: Introduction: Daratumumab (DARA) is a human IgGκ monoclonal antibody targeting CD38 with a direct on-tumor and immunomodulatory mechanism of action. DARA is approved as monotherapy and in combination with standard-of-care regimens for patients with relapsed/refractory multiple myeloma and in combination with standard-of-care regimens for patients with NDMM. In the primary analysis of the phase 3 MAIA study (median follow-up, 28.0 months), D-Rd significantly improved progression-free survival (PFS; median not reached [NR] vs 31.9 months; hazard ratio [HR], 0.56; 95% confidence interval [CI], 0.43-0.73; P< 0.001) and achieved a> 3-fold increase in minimal residual disease (MRD)-negativity rate (10-5 sensitivity threshold; 24.2% vs 7.3%; P< 0.001) versus Rd alone in transplant-ineligible patients with NDMM (Facon T, N Engl J Med 2019). With longer follow-up (median follow-up, 56.2 months), D …