Direct comparison of Dara+len vs. len maintenance for those with +MMR after Auto-HSCT. MRD-neg conversion rates were higher in the combo arm. This is likely going to continue gaining traction in this group of patients.
No randomized trial has directly compared daratumumab and lenalidomide (D-R) maintenance with standard-of-care lenalidomide (R) alone after transplant. Herein, we report the primary results of the phase 3 AURIGA study evaluating D-R vs R maintenance in patients with newly diagnosed multiple myeloma (NDMM) who had very good or better partial response, were minimal residual disease (MRD)-positive (10–5) and anti-CD38–naïve after transplant. Two hundred patients were randomly assigned (1:1) to D-R (n = 99) or R (n = 101) maintenance for up to 36 cycles. The MRD-negative (10–5) conversion rate by 12 months from start of maintenance (primary end point) was significantly higher for D-R than R (50.5% vs 18.8%; odds ratio [OR], 4.51; 95% confidence interval [CI], 2.37-8.57; P < .0001). MRD-negative (10–6) conversion rate was similarly higher with D-R (23.2% vs 5.0%; OR, 5.97; 95% CI, 2.15-16.58; P = .0002). At median follow-up (32.3 months), D-R achieved a higher overall MRD-negative (10–5) conversion rate (D-R, 60.6% vs R, 27.7%; OR, 4.12; 95% CI, 2.26-7.52; P < .0001) and complete response rate or better (75.8% vs 61.4%; OR, 2.00; 95% CI, 1.08-3.69; P = .0255) vs R. Progression-free survival (PFS) favored D-R vs R (hazard ratio, 0.53; 95% CI, 0.29-0.97); estimated 30-month PFS rates were 82.7% for D-R and 66.4% for R. Incidences of grade 3/4 cytopenias (54.2% vs 46.9%) and infections (18.8% vs 13.3%) were slightly higher with D-R than R. In conclusion, D-R maintenance achieved a higher MRD-negative conversion rate and improved PFS after transplant vs R, with no new safety concerns. This trial was registered at www.clinicaltrials.gov as #NCT03901963.
Retrospective assessment of the SWOG0777 and SWOG 1211 studies showing that dose reductions in dexamethasone did not affect outcomes. Nice to see this does not have a negative impact, as I have been doing this for years in my elderly patients who would not tolerate the ultra-high dose steroids used in these trials.
MRD at year 1 can be prognostic in pt who had AutoBMT followed by maintenance linolidomide. Please use MRD wisely … it can be expensive.
First line regimen, first quad for transplant INELIGIBLE patients, PFS at 5 years is 63% vs 45% for RVD. This will probably be the new standard of care for this population with manageable toxicity. Recall Dara RVD is for transplant eligible patients.
This regimen vs pomalidomie, bortezomib and dexma. 12-month estimated progression-free survival with BPd was 71% compared with 51% with PVd (hazard ratio for disease progression or death, 0.52) Ocular toxicity Grade 3 or higher adverse events occurred in 94% of the patients in the BPd group and 76% of those in the PVd group.
This regimen vs Daratumamab, bortezomib and dexa. Median progression-free survival was 36.6 months in the BVd group and 13.4 in the DVd Overall survival at 18 months was 84% in the BVd group and 73% in the DVd group. Again higher ocular toxicity but manageable with dose adjustment and supportive therapy. Those trials may be the come back for Belantamab.
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