IMS 2025 | The addition of daratumumab to lenalidomide as maintenance therapy in NDMM: the AURIGA trial

It’s my pleasure to present the updated safety and efficacy data for the randomized Phase III AURIGA study of daratumumab plus lenalidomide versus lenalidomide alone as maintenance therapy in newly diagnosed myeloma patients who were MRD positive after autologous stem cell transplant. This study, as I mentioned, was a randomized Phase III study. It took patients who were in at least VGPR after their autologous stem cell transplant. These patients were CD38 antibody naive before the study. They were MRD positive at the 10 to the minus fifth threshold at study entry. They were randomized one to one to either dual therapy with daratumumab sub-Q plus lenalidomide or lenalidomide alone for up to 36 cycles as maintenance therapy. They were also stratified by high-risk cytogenetics. The subgroups within each of the two cohorts were generally well balanced. However, there was an increase in high-risk 17p in the DR cohort which favors the R cohort and an increased number of high-risk cytogenetics by the modified IMS 2024 criteria in the DR subgroup which favors the R subgroup as well. Other than that they were well balanced. After a median of 40.3 months of follow-up we have updated results that we’re presenting here. Previously presented data at the 12-month MRD time point. MRD was assessed at 12, 18, 24, and 36 months. So here we’re focusing on the 24-month time point of MRD analysis. And we show that we continue to see a doubling of the MRD negative conversion rate at both the 10 to the minus fifth and 10 to the minus six sensitivities at the 24 month time point. A benefit of MRD negative conversion was seen across all subgroups regardless of race, stage, or age. Additionally, we saw a benefit of DR versus R among all cytogenetic risk groups, including the modified IMS 2024 criteria. DR improved the cumulative MRD conversion rate between the 12 and 24 month time point. It also improved the six month sustained MRD negativity rate and the 12 month sustained MRD negativity rate compared to R alone. With 40.3 months of follow up, DR led to a longer progression free survival compared to R. And also, there was a trend toward improved overall survival, but further follow-up is needed for that endpoint, which is immature. There was no increase in safety concerns. There was no increase in grade 3 or 4 safety events with DR compared to R. There was no increased risk of discontinuation due to safety concerns with doublet therapy compared to R. So in conclusion, DR compared to R maintenance for newly diagnosed myeloma after stem cell transplant led to a doubling of the MRD negative conversion rates at both 10 to the minus 5th sensitivity and 10 to the minus 6th at 24 months. Led to an increase in progression-free survival compared to revlimid alone. Also showed a trend toward a favored overall survival advantage. And showed no new safety concerns compared to revlimid alone. And overall, these efficacy and safety data support the addition of daratumumab plus lenalidomide as maintenance therapy for patients who are MRD positive after stem cell transplant.

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