MAIA Trial Results of Daratumumab, Lenalidomide, and Dexamethasone versus Lenalidomide and Dexamethasone in NDMM

Interim analysis results of the phase 3 MAIA trial demonstrated that frontline daratumumab plus lenalidomide/dexamethasone provided OS benefit compared with lenalidomide/dexamethasone in patients with NDMM ineligible for stem-cell transplantation.

Primary analysis of the ongoing, multicenter, randomized, open-label, phase 3 MAIA trial (NCT02252172) demonstrated (median follow-up, 28.0 months) a significant improvement in progression-free survival (PFS) with anti-CD38 monoclonal antibody daratumumab plus lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in transplantation-ineligible patients with newly diagnosed multiple myeloma (NDMM). The updated efficacy and safety results from a prespecified interim analysis for overall survival (OS) were published in the November issue of Lancet Oncology and summarized here.

Between March 18, 2015, and January 15, 2017, the MAIA trial enrolled patients aged ≥18 years who had NDMM, had an Eastern Cooperative Oncology Group performance status score of 0-2, and were ineligible for high-dose chemotherapy with autologous stem-cell transplantation. Eligible patients were randomized 1:1 to receive the experimental regimen consisting of 28-day cycles of intravenous daratumumab (16 mg/kg, weekly during cycles 1-2, every 2 weeks in cycles 3-6, and every 4 weeks thereafter) plus oral lenalidomide (25 mg on days 1-21 of each cycle) and oral dexamethasone (40 mg on days 1, 8, 15, 22 of each cycle; daratumumab group), or lenalidomide and dexamethasone alone. Treatment stratification was by International Staging System disease stage, geographical region, and age. The primary end point was centrally assessed PFS; secondary end point was OS.

A total of 737 patients were enrolled in the study. Of these, 368 patients were randomized to the daratumumab group and 369 to the control group. In the intent-to-treat population (at a median follow-up of 56.2 months), daratumumab therapy resulted in a significant reduction (47%) in the risk for progression compared with control (median PFS, not reached vs 34.4 months; hazard ratio [HR], 0.53; P <.0001). The PFS benefit also translated to a significant reduction (32%) in the risk for death (median OS, not reached in both groups; HR, 0.68; P = .0013).

The most common grade ≥3 treatment-emergent adverse events occurring in >15% of patients in the daratumumab group were neutropenia (54%), pneumonia (19%), anemia (17%), and lymphopenia (16%). Serious adverse events occurred in 77% of patients in the daratumumab group and 70% of patients in the control group. Treatment-related deaths were similar between the 2 groups (4% vs 3%, respectively).

Interim analysis results of the phase 3 MAIA trial demonstrated that frontline daratumumab plus lenalidomide/dexamethasone provided PFS and OS benefit compared with lenalidomide/dexamethasone in patients with NDMM ineligible for stem-cell transplantation.

Source: Facon T, Kumar SK, Plesner T, et al. Daratumumab, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone alone in newly diagnosed multiple myeloma (MAIA): overall survival results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2021;22:1582-1596.