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.

AURIGA is a multicenter, open-label study 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.