**Johnson & Johnson (J&J) has shared positive data from a late-stage study of its subcutaneous CD38-directed antibody Darzalex Faspro (daratumumab and hyaluronidase-fihj) in smouldering multiple myeloma (SMM), an early precursor of active multiple myeloma (MM).**
Results from the phase 3 AQUILA trial, which is comparing J&J’s drug to active monitoring in 390 SMM patients at high risk of progression, were presented at this year’s American Society of Hematology (ASH) annual meeting and simultaneously published in _The New England Journal of Medicine_.
More than 35,000 people are expected to be diagnosed with MM in the US this year, with SMM accounting for 15% of all newly-diagnosed cases.
SMM is not generally treated until active MM develops. However, recent evidence has suggested that patients at high-risk for progression to active MM could benefit from earlier therapeutic intervention.
Darzalex Faspro demonstrated a statistically significant improvement in progression-free survival at a median follow-up of 65.2 months, with 63.1% of patients who received the drug remaining progression-free at 60 months, compared to 40.8% of those in the active monitoring group.
Among patients who were retrospectively categorised as having high-risk SMM, median progression-free survival was not reached in the Darzalex Faspro arm versus 22.1 months for active monitoring.
Overall survival was also extended with Darzalex Faspro, with five-year survival rates of 93% versus 86.9% for active monitoring, and patients who received J&J’s drug saw a higher overall response rate of 63.4% compared to 2% with active monitoring.
The presentation comes less than a month after J&J announced that it had submitted regulatory applications with the European Medicines Agency and US Food and Drug Administration for the use of subcutaneous Darzalex as a monotherapy in adults with high-risk SMM, based on the phase 3 AQUILA data.
Jordan Schecter, vice president, disease area leader, MM, J&J Innovative Medicine, said the company is “encouraged by the findings from the AQUILA study, which may help to underscore the critical role of early disease intervention and potential to improve outcomes for patients with high-risk SMM”.