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 (NCT03901963) and presented at the 21st International Myeloma Society Annual Meeting.

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; P < .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; P = .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; P = .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.