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  • AQUILA: Daratumumab shows promise in SMM
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AQUILA: Daratumumab shows promise in SMM

Last updated: 23rd May 2025
Published:23rd May 2025

By Megan Lee

Daratumumab, an anti-CD38 monoclonal antibody, significantly reduces disease progression risk and improves survival in people with high-risk smoldering multiple myeloma (SMM), compared with active monitoring.

The phase 3, open-label, multicenter, randomized AQUILA trial suggests that early intervention with subcutaneous daratumumab monotherapy improves progression-free survival (PFS) and reduces the risk of progression to active MM or death by 51% compared with active monitoring, the current standard of care.

PFS at 5 years was 63.1% of the 194 patients receiving daratumumab, compared with 40.8% of the 196 patients in the active monitoring group.

Over a median follow-up of 65.2 months, 34.5% of patients receiving daratumumab progressed or died, compared with 50.5% in the active monitoring group (HR, 0.49; 95% CI, 0.36–0.67; P<0.001). The median time to disease progression was 44.1 months in the daratumumab group versus 17.8 months in the active-monitoring group (HR, 0.51; 95% CI, 0.40–0.66).

Patients receiving daratumumab had better overall survival rates at 5 years (93.0% vs 86.9%). However, the researchers caution that the initiation of various subsequent therapies at disease progression may complicate the assessment of long-term outcomes, such as overall survival.

Response rates were superior in the daratumumab group, with 8.8% achieving a complete response and 29.9% achieving a very good partial response or better, compared with 0% and 1.0%, respectively, in the active-monitoring group.

This latest research was conducted by Meletios Dimopoulos (National and Kapodistrian University of Athens, Greece) and colleagues and reported in The New England Journal of Medicine.

“The findings are notable given that results of a recent real-world longitudinal study suggested that close monitoring alone may not prevent the occurrence of clinically significant end-organ damage in patients with high-risk smoldering multiple myeloma,” they write.

The researchers defined SMM according to the International Myeloma Working Group (IMWG) criteria. They caution that SMM criteria have evolved since AQULIA was launched and vary between studies, highlighting the need for more uniform classification.

Daratumumab had an “acceptable safety profile,” and there were no unexpected safety concerns. It was associated with a higher incidence of grade 3 or 4 adverse events (AEs; 40.4% vs 30.1%), with hypertension being the most common (5.7% vs. 4.6%). Serious AEs occurred in 29.0% in the daratumumab group versus 19.4% in the active monitoring group, primarily pneumonia (3.6% vs 0.5%). Grade 3 or 4 infections were reported more frequently in the daratumumab group (16.1% vs 4.6%). Treatment discontinuation due to AEs occurred in 5.7% in the daratumumab group, while deaths related to AEs occurred in 1.0% of patients in the daratumumab group versus 2.0% in the active-monitoring group.

Developed by EPG Health, for Medthority. The article has been developed independently of any sponsor.

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