Photo Credit: Nemes Laszlo
Daratumumab reduced progression to multiple myeloma (MM) and prolonged overall survival (OS) in patients with high-risk smoldering MM (SMM), representing an opportunity to delay or avoid end-organ damage in these patients.
The phase 3 AQUILA study (NCT03301220) randomly assigned 390 patients with smoldering MM 1:1 to daratumumab or active monitoring1. The primary outcome was progression-free survival (PFS). Meletios Dimopoulos, MD, from the University of Athens, in Greece, presented the primary results of the trial.
After a median follow-up of 65.2 months, the primary endpoint was met: median PFS was 41.5 months in the control arm and ‘not reached’ in the daratumumab arm (HR 0.49; 95% CI 0.36–0.67; P<0.001). “Daratumumab significantly reduced the risk for progression to MM or death by 51%,” commented Dr. Dimopoulos. The PFS rates at 60 months were 63.1% and 40.8%, favoring the daratumumab arm. The OS rates were 93.0% and 86.9% at 60 months of follow-up (HR 0.52; 95% CI 0.27–0.98). “Thus, early intervention with fixed duration daratumumab extended OS compared with active monitoring,” said Dr. Dimopoulos. He noted that the benefit of daratumumab appeared to be more pronounced in ‘Mayo 2018 criteria for high-risk’ patients.
In total, 5.7% of the participants discontinued the daratumumab arm due to treatment-emergent AEs. No new safety issues were identified with daratumumab monotherapy in this population.
“AQUILA strongly favored early intervention with daratumumab in patients with high-risk SMM,” decided Dr. Dimopoulos. “It offers a chance to improve health outcomes, like survival or delayed progression to MM, in these patients.”
Medical writing support was provided by Robert van den Heuvel.
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