J&J Seeks Approval for Subcutaneous Darzalex in Smoldering Multiple Myeloma
Key Insights
Johnson & Johnson has submitted applications to the EMA and FDA for subcutaneous Darzalex (daratumumab) as a monotherapy for high-risk smoldering multiple myeloma (search) (SMM).
The applications are based on positive phase 3 AQUILA trial results, which showed significant improvement in progression-free survival (PFS) with SC Darzalex compared to active monitoring.
At a median follow-up of 65.2 months, the 60-month PFS rate was 63.1% for SC Darzalex versus 40.8% for active monitoring, potentially shifting the treatment paradigm for high-risk SMM.
Johnson & Johnson (J&J) has announced regulatory submissions to both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) for subcutaneous (SC) Darzalex (daratumumab) as a monotherapy for adults with high-risk smoldering multiple myeloma (search) (SMM). This seeks to address an unmet need for early intervention in patients at high risk of progressing to active multiple myeloma (search) (MM).
The applications are supported by data from the phase 3 AQUILA trial, a study comparing SC Darzalex to active monitoring in 390 SMM patients at high risk of progression. The results, to be presented at the American Society of Hematology (ASH) Annual Meeting, demonstrate a significant improvement in progression-free survival (PFS) with SC Darzalex.
AQUILA Trial Results
At a median follow-up of 65.2 months, the median PFS was not reached in the SC Darzalex group, compared to 41.5 months in the active monitoring group. The estimated 60-month PFS rate was 63.1% in the SC Darzalex arm versus 40.8% in the active monitoring arm. This indicates a substantial benefit from early intervention with Darzalex.
Furthermore, the data showed that SC Darzalex reduced the risk of progressing to first-line MM treatment. Only 33% of patients in the SC Darzalex group required first-line treatment, compared to 52% in the active monitoring group at the clinical cutoff.
Clinical Significance
SMM accounts for approximately 15% of newly diagnosed multiple myeloma (search) cases. While SMM is typically monitored until active MM develops, recent evidence suggests that early therapeutic intervention may benefit high-risk patients. Yusri Elsayed, global therapeutic area head, oncology, innovative medicine, J&J, stated that there remains an unmet need for effective and well-tolerated early interventions for people living with SMM at high-risk of progressing to active disease. The approval of Darzalex could potentially shift the treatment paradigm for this patient population.
Darzalex: A New Standard of Care?
Darzalex, a CD38 (search)-directed antibody, has already established itself as a standard of care in the treatment of multiple myeloma (search). These submissions to the FDA and EMA could potentially make it the first approved treatment for patients with high-risk SMM.