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AURIGA: Daratumumab + lenalidomide maintenance in newly diagnosed MM
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Daratumumab is approved as monotherapy and combination therapy in newly diagnosed multiple myeloma (NDMM). Results from the phase III AURIGA trial (NCT03901963) evaluating the safety and efficacy of daratumumab-lenalidomide (D-R) maintenance therapy in patients with NDMM who achieved ≥VGPR, were anti-CD38 naïve, or MRD-positive after transplant were published in Blood by Badros et al.1 Patients were randomized to either D-R (n = 99) or R (n = 101) maintenance.1 The primary endpoint was the proportion of patients who achieved MRD negativity (10–5) by 12 months after maintenance treatment initiation.1 |
| Key learnings |
| D-R maintenance improved MRD-negative conversion rates, with MRD-negative rates (10–5) of 50.5% with D-R vs 18.8% with R (OR, 4.51; 95% CI, 2.37–8.57; p < 0.0001). |
| At a median follow-up of 32.3 months, overall MRD negative rates (10–5) (60.6% vs 27.7%; OR, 4.12; 95% CI, 2.26–7.52; p < 0.001) and MRD negativity for ≥12 months (17.2% vs 5.0%; OR, 4.08; 95% CI, 1.43–11.62; p = 0.0065) were higher with D-R vs R. |
| CRR (75.8% vs 61.4%; OR, 2.00; 95% CI, 1.08–3.69; p = 0.0255), PFS (HR, 0.53; 95% CI, 0.29–0.97), and estimated 30-month PFS (82.7% vs 66.4%) were higher with D-R vs R. |
| Grade 3 or 4 AEs occurred in 74.0% and 67.3% of patients in the D-R vs R groups, with SAEs in 30.2% and 22.4% of patients, respectively. Rates of Grade 3 or 4 cytopenia (54.2% vs 46.9%) and infections (18.8% vs 13.3%) were also higher in the D-R vs R group. |
| These findings suggest that D-R maintenance improved MRD-negative conversion rates, PFS, and achieved deeper responses after transplant in patients with NDMM, with no new safety concerns. |
Abbreviations: AE, adverse event; CI, confidence interval; CRR, complete response rate; D-R, daratumumab-lenalidomide; HR, hazard ratio; MRD, measurable residual disease; NDMM, newly diagnosed multiple myeloma; OR, odds ratio; PFS, progression-free survival; R, lenalidomide; SAE, serious adverse event; VGPR, very good partial response.
References
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