Daratumumab (anti-CD38) cuts progression risk in Japanese high-risk SMM vs monitoring (AQUILA)

Daratumumab is an anti-CD38 monoclonal antibody given as monotherapy; in this exploratory post hoc Japanese subgroup of the Phase 3 AQUILA trial (NCT03301220), patients with high-risk smoldering multiple myeloma received daratumumab (n=15) vs active monitoring (n=13). At median follow-up 60.9 months, median PFS was 59.1 vs 24.8 months (HR 0.25, 95% CI 0.10–0.65) and ORR was 86.7% vs 7.7% (odds ratio 78.0; 95% CI 6.24–974.71); OS was immature. Grade ≥3 AEs occurred in 33.3% on daratumumab with no discontinuations and no new safety signals. These results are consistent with global AQUILA, which led to US approval of subcutaneous daratumumab for high-risk SMM; current ASCO guidance includes either active monitoring or daratumumab for up to 36 months.