Daratumumab With Lenalidomide Enhances Outcomes in NDMM
Ashraf Z. Badros, MB, ChB, discusses the results of the phase 3 AURIGA trial which evaluated daratumumab and lenalidomide vs lenalidomide maintenance in patients with newly diagnosed multiple myeloma.
Ashraf Z. Badros, MB, ChB, professor of medicine, director of the Multiple Myeloma Service, and vice chair of the Clinical Research Committee for the Program in Oncology at the University of Maryland School of Medicine in Baltimore, discusses the results of the phase 3 AURIGA trial (NCT03901963) which evaluated daratumumab (Darzalex) and lenalidomide vs lenalidomide maintenance in patients with newly diagnosed multiple myeloma.
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0:10 | The trial primary’s end point, which is MRD-negative conversion rate at 12 months, was 50.5% for lenalidomide and daratumumab vs 10.8% for lenalidomide alone, and that difference was statistically significant.
0:29 | Patients achieved deeper complete responses when they received the daratumumab/lenalidomide after randomization. It was 75.8% vs 61% in the lenalidomide alone arm and progression-free survival at 30 months of follow-up was 83% for the daratumumab/lenalidomide arm vs 66% for lenalidomide alone arm, with 47% reduction in the risk of progression or deaths favoring daratumumab and lenalidomide vs lenalidomide alone. These are the main results from the trial.
1:12 | Adverse events overall were expected, with slightly higher rates in the daratumumab/lenalidomide arm. Serious adverse events occurred in 30% of patients in the [daratumumab/lenalidomide] arm compared with 22% in the lenalidomide arm. The most common adverse event was neutropenia, which was noted in approximately 54% of the [daratumumab/lenalidomide] arm and 47% of the lenalidomide arm. This trial was conducted during COVID-19, and more COVID infections were observed in the [daratumumab/lenalidomide] arm.
1:50 | However, surprisingly, there was no significant high-grade toxicity noted in the trial, and most patients did well. The discontinuation rate due to adverse events was higher in the [daratumumab/lenalidomide] arm, at 14%, compared with 8% in the lenalidomide arm. It is important to note that patients stayed longer on the daratumumab/lenalidomide arm, with a median duration of 30 months vs 20 months for the lenalidomide arm, indicating nearly an extra year of treatment with [daratumumab/lenalidomide]. We believe that the longer drug exposure accounts for the additional reporting and higher risk. Aside from cytopenia and infection, no new safety signals were identified.
