Daratumumab Dropped Risk of Progression by More Than Half in Smoldering Multiple Myeloma

Daratumumab (Darzalex Faspro; Johnson & Johnson) use was associated with a 51% reduction in risk of disease progression for patients with smoldering multiple myeloma, when compared with similar patients who were actively monitored but not treated, according to results of a study presented at the 66th ASH Annual Meeting and Exposition held in San Diego, CA.¹

Meletios A. Dimopoulos, MD, of the National and Kapodistrian University of Athens School of Medicine, discussed the AQUILA study (NCT03301220), a phase 3 clinical trial that randomly assigned 390 patients to receive either subcutaneous daratumumab every 28 days or active monitoring for up to 36 months or until their condition progressed to multiple myeloma, whichever came first.

After a median follow-up of approximately 5.5 years, Dimopoulos and other study researchers noted that 63.1% of the patients assigned to daratumumab had not progressed to active multiple myeloma, compared with 40.8% of those assigned to active monitoring. For patients who received active monitoring, the median time to a multiple myeloma diagnosis was 41.5 months.

The researchers noted the overall response rate was 63.4% among patients receiving daratumumab, compared with 2.0% for those being actively monitored. In the daratumumab group, 33% of patients had begun treatment for active multiple myeloma compared with 52% of those in the active monitoring group at the time of clinical cutoff.

Dr Dimopoulos cautioned that the findings apply only to patients whose smoldering multiple myeloma has specific features that place them at the highest risk for developing active cancer. Future studies should test whether using daratumumab in combination with other agents can further improve outcomes for these patients, he said.

This study, which was published in the New England Journal of Medicine as well as presented at ASH, was funded by Janssen Research & Development, LLC, a sister company of Janssen Biotech, Inc, which manufactures daratumumab. Both companies are subsidiaries of Johnson & Johnson.

Reference

1. Dimopoulos M, Voorhees P, Schejesvold F, et al. Phase 3 randomized study of daratumumab monotherapy versus active monitoring in patients with high-risk smoldering multiple myeloma: primary results of the Aquila study. Presented at: 66th ASH Annual Meeting and Exposition. December 7-10, 2024; San Diego, CA. Abstract 773.