Dr Badros on the Design of the AURIGA Study of Daratumumab/Lenalidomide in Newly Diagnosed Myeloma

Ashraf Z. Badros, MBCHB, professor, medicine, Medical Oncology, Hematology Oncology, University of Maryland Medical System, discusses the design and methodoliges of the phase 3 AURIGA study (NCT03901963). Notably, the investigation is studying treatment with subcutaneous daratumumab (Darzalex) plus lenalidomide (Revlimid) compared with lenalidomide monotherapy in the maintenance setting in patients with newly diagnosed multiple myeloma following stem cell transplant. Primary findings from this trial were presented at the 

21st International Myeloma Society Annual Meeting

 being conducted across sites in the United States and Canada, Badros begins. The trial enrolled patients who had received at least 4 cycles of induction therapy (excluding daratumumab or isatuximab-irfc [Sarclisa]) and had undergone a transplant within 12 months prior to screening, he explains. Eligible patients were required to have achieved a very good partial response or better and to be minimal residual disease (MRD) positive at a sensitivity of 10⁻⁵, as determined by next-generation sequencing, Badros reports.

Patients were randomly assigned to each arm in a 1:1 ratio, with stratification based on cytogenetic risk, and randomization was completed within 6 months post-transplant, he expands. The primary end point of the study focuses on MRD-negative conversion rates at 12 months post-maintenance initiation, assessing the ability of the combination regimen to achieve deeper responses than lenalidomide monotherapy, Badros adds. MRD status was monitored at 12, 18, 24, and 36 months to evaluate response durability and long-term effectiveness, he says.

The AURIGA study investigators hypothesized that the addition of daratumumab to standard lenalidomide maintenance therapy could enhance outcomes for patients with residual disease post-transplant, Badros continues. By stratifying patients based on cytogenetic risk and closely monitoring MRD status over time, the trial provided insights into the clinical effects of this dual-agent maintenance strategy on disease progression and survival in high-risk and standard-risk myeloma populations, he concludes.

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Ashraf Z. Badros, MBCHB, discusses the design of the AURIGA trial of daratumumab plus lenalidomide in newly diagnosed myeloma following transplant.

Dr Badros on the Efficacy of Daratumumab Plus Lenalidomide in Newly Diagnosed Myeloma

Ashraf Z. Badros, MBCHB, professor, medicine, Medical Oncology, Hematology Oncology, University of MarylandMedical System, discusses the investigation of subcutaneous daratumumab (Darzalex) plus lenalidomide (Revlimid) vs lenalidomide monotherapy in the maintenance setting in patients with newly diagnosed multiple myeloma following transplant. Notably, 

primary results were derived from the phase 3 AURIGA study

Patients eligible for AURIGA are between 18 and 79 years of age, have received at least 4 cycles of induction therapy, and have undergone autologous stem cell transplantation (ASCT) within 12 months. The trial randomly assigned patients 1:1 into 2 arms: daratumumab plus lenalidomide or lenalidomide alone, with patients in both armsreceiving up to 36 cycles of maintenance therapy. The primary end point was the minimal residual disease (MRD)–negative conversion rate from baseline to 12 months after the start of maintenance at a sensitivity of 10–5, with secondary end points including progression-free survival (PFS), overall MRD-negative conversion rates, and safety. The AURIGA trial was the first study to directly compare the efficacy of adding daratumumab to lenalidomide vs using lenalidomide alone, which is currently the standard of care during the maintenance phase for multiple myeloma following ASCT, Badros begins. At the time of the AURIGA primary analysis, all patients had completed 12 months of maintenance therapy.

In the intention-to-treat population, the daratumumab and lenalidomide combination yielded an MRD-negative conversion rate of 50.5% compared with 18.8% in the lenalidomide-only arm (odds ratio [OR], 4.51; 95% CI, 2.37-8.57; 

 < .0001), he explains. This difference was statistically significant, highlighting the added benefit of daratumumab, Badros notes. At a median follow-up of 32 months, the rate of complete response (CR) or better was also significantly higher in the daratumumab arm, with 75.8% of patients achieving a CR or better in this arm compared with 61.4% of those in the lenalidomide-only group (OR, 2.00; 95% CI, 1.08-3.69; 

 = .0255), he reports. Moreover, treatment with the combination therapy resulted in a 47% reduction in the risk of disease progression (HR, 0.53; 95% CI, 0.29-0.97; 

 = .0361), Badros says. The PFS rates at 30 months further demonstrated the advantage of the combination therapy, he notes, concluding that the data strongly favor the daratumumab combination in multiple myeloma maintenance.

Ashraf Badros, MBCHB, discusses the addition of subcutaneous daratumumab to lenalidomide vs lenalidomide alone in newly diagnosed myeloma following ASCT. 

Ashraf Badros, MBCHB

Articles

Dr Badros on the Design of the AURIGA Study of Daratumumab/Lenalidomide in Newly Diagnosed Myeloma

Dr Badros on the Efficacy of Daratumumab Plus Lenalidomide in Newly Diagnosed Myeloma