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ASH 2024 | Primary results of the AQUILA study: daratumumab versus active monitoring in high-risk SMM

Meletios Dimopoulos, MD, Kapodistrian University of Athens School of Medicine, Athens, Greece, comments on the results of the AQUILA study (NCT03301220), a Phase III randomized trial evaluating daratumumab monotherapy versus active monitoring in patients with high-risk smoldering multiple myeloma (SMM). Dr Dimopoulos highlights a significant improvement in progression-free survival in favor of daratumumab and a trend toward an overall survival advantage, suggesting that daratumumab may become a new standard of care for patients with high-risk SMM. This interview took place at the 66th ASH Annual Meeting and Exposition, held in San Diego, CA.

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Transcript (AI-generated)

The AQUILA study included patients with high-risk myeloma as they were defined in 2017 when the study was initiated and the patients were randomized to either observation or to treatment with daratumumab for three years. The primary endpoint of the study was progression to symptomatic myeloma according to the SLIM-CRAB criteria and we were happy to observe that there was a significant improvement in the progression-free survival in favor of daratumumab with a hazard ratio 0...

The AQUILA study included patients with high-risk myeloma as they were defined in 2017 when the study was initiated and the patients were randomized to either observation or to treatment with daratumumab for three years. The primary endpoint of the study was progression to symptomatic myeloma according to the SLIM-CRAB criteria and we were happy to observe that there was a significant improvement in the progression-free survival in favor of daratumumab with a hazard ratio 0.5 indicating that there was a 50% reduction of the probability of progression or death in favor of daratumumab. Furthermore, there was also a trend for an overall survival advantage, which actually was statistically significant in favor of daratumumab treatment. So we believe that it is likely that daratumumab may become a new standard of care for the patients with high-risk smoldering myeloma.

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Disclosures

SANOFI: Honoraria; REGENERON: Honoraria; MENARINI: Honoraria; TAKEDA: Honoraria; GSK: Honoraria; BMS: Honoraria; JANSSEN: Honoraria; BEIGENE: Honoraria; SWIXX: Honoraria; ASTRA ZENECA: Honoraria; AMGEN: Honoraria, Membership on an entity’s Board of Directors or advisory committees.