The phase 3 AQUILA study (NCT03301220) randomised 390 patients with smouldering MM 1:1 to daratumumab or to active monitoring1. The primary outcome was progression-free survival (PFS). Dr Meletios Dimopoulos (University of Athens, 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 of progression to MM or death by 51%,” commented Dr Dimopoulos. The PFS rates at 60 months were 63.1% and 40.8%, favouring 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 high-risk’ patients.
In total, 5.7% of the participants discontinued the daratumumab arm due to treatment-emergent adverse events. No new safety issues were identified with daratumumab monotherapy in this population.
“AQUILA strongly favoured early intervention with daratumumab in patients with high-risk smouldering MM,” 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.