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    Treatment of Newly Diagnosed Myeloma (excluding t-cell redirection therapy)

    (OA-47) Updated Efficacy and Safety Results of Subcutaneous Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Therapy in Newly Diagnosed Multiple Myeloma After Transplant: AURIGA Study

    Saturday, September 20, 2025
    08:30 - 08:40 East Coast USA Time
    Location: Room 701
    Introduction: Lenalidomide (R) maintenance (maint.) is the current standard of care following autologous stem cell transplant (ASCT) for patients (pts) with multiple myeloma (MM). Per the primary analysis of the phase 3 AURIGA trial (NCT03901963), addition of subcutaneous daratumumab (DARA SC) to R maint. (D-R) in anti-CD38–naïve pts who were minimal residual disease (MRD) positive (pos) post-ASCT improved MRD-negative (neg) conversion by 12 mo and progression-free survival (PFS) compared to R maint. alone (presented at IMS 2024). Herein, updated AURIGA efficacy and safety results are reported at 24 mo from start of maint.

    Methods: Eligible pts with newly diagnosed MM were aged 18-79 yr, in very good partial response or better (≥VGPR) and MRD pos (10–5; NGS) post-ASCT, and anti-CD38 naïve; received ≥4 induction cycles; and enrolled within 6 mo of ASCT. Pts were stratified by cytogenetic risk and randomized 1:1 to 28-d cycles of R maint. ± DARA SC for ≤36 cycles or until progression, unacceptable toxicity, or withdrawal. The primary endpoint was MRD-neg (10–5) conversion by 12 mo from maint. start.

    Results:

    200 pts were randomized (D-R, n=99; R, n=101). Baseline characteristics were balanced between groups. Both groups had received a median of 5 induction cycles (range, 4-8) before study entry. A median of 36.0 and 25.5 maint. cycles has been received by D-R and R pts, respectively; 88.5% and 78.6% completed 12 cycles, and 78.1% and 53.1% completed 24 cycles. At a median follow-up of 40.3 mo, D-R maint. continued to demonstrate higher MRD-neg conversion rates versus R, both at 10–5 (60.6% vs 28.7%; OR, 3.92 [95%CI, 2.16-7.14]; P< 0.0001) and 10–6 thresholds (36.4% vs 13.9%; OR, 3.59 [95%CI, 1.78-7.23]; P=0.0003). MRD-neg (10−5) conversion rates with complete response or better were 55.6% for D-R and 23.8% for R (OR, 4.11 [95%CI, 2.23-7.59]; P< 0.0001). D-R maint. led to doubling of the ≥6-mo sustained MRD-neg (10−5) conversion rate (D-R 42.4% vs R 17.8%; OR, 3.45 [95%CI, 1.80-6.61]; P=0.0002) and tripling of the ≥12-mo sustained rate (29.3% vs 7.9%; OR, 4.88 [95%CI, 2.09-11.38]; P=0.0001) versus R alone. Per investigator assessment, a 45% reduction in the risk of disease progression or death was seen with D-R versus R (HR, 0.55 [95%CI, 0.33-0.91]; P=0.0183), with estimated 36-mo PFS rates of 76.8% for D-R and 61.4% for R. Grade 3/4 treatment-emergent adverse events (TEAEs) occurred in 75.0% of D-R pts and 73.5% of R pts, with neutropenia (49.0% vs 45.9%) and infections (19.8% vs 14.3%) being the most common. Serious TEAEs occurred in 31.3% of D-R pts and 25.5% of R pts, while TEAEs led to maint. discontinuation in 12.5% of D-R pts and 9.2% of R pts. Grade 5 TEAEs occurred in 2 D-R pts and 1 R pt (all infections).

    Conclusions: Updated efficacy and safety data from AURIGA continue to demonstrate the value of adding DARA SC to R maint., as evidenced by continued higher MRD-neg conversion rates and a PFS benefit, with no new safety signals observed.