Johnson & Johnson Announces Positive Phase 3 AQUILA Results for Darzalex in Smoldering Myeloma

Johnson & Johnson today announced positive results from the Phase 3 AQUILA trial evaluating daratumumab (Darzalex) in patients with high-risk smoldering multiple myeloma (SMM). The trial met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival compared to active monitoring. The 5-year PFS rate was 63.1% for daratumumab versus 40.8% for active monitoring. These results support the potential of daratumumab as a treatment for high-risk SMM to delay progression to active multiple myeloma. J&J plans to submit regulatory applications for daratumumab in high-risk SMM.