Johnson & Johnson (J&J) has announced the submission of regulatory applications to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) seeking approval for a new indication for DARZALEX® FASPRO® (daratumumab and hyaluronidase-fihj) in the U.S. and DARZALEX® subcutaneous (SC) formulation in the European Union (EU). The applications are supported by data from the Phase 3 AQUILA study (NCT03301220) evaluating DARZALEX® FASPRO® as monotherapy for adult patients with high-risk smoldering multiple myeloma.
Smoldering multiple myeloma is an early, asymptomatic precursor to active multiple myeloma, characterized by abnormal cells in the bone marrow. Approximately 15% of newly diagnosed multiple myeloma cases are classified as smoldering, with half of high-risk cases progressing to active myeloma within two years. Currently, standard practice involves active monitoring until progression to active myeloma.
AQUILA Study Details
The AQUILA study (NCT03301220) is a randomized, multicenter Phase 3 trial comparing DARZALEX® FASPRO® to active monitoring in 390 patients with high-risk smoldering multiple myeloma. The primary endpoint is progression-free survival (PFS), with secondary endpoints including time to progression (TTP), overall response rate (ORR), and overall survival (OS). Patients diagnosed with smoldering multiple myeloma within the last five years were eligible, excluding those with prior treatment for smoldering or active multiple myeloma.
Potential Impact on Treatment Paradigm
Yusri Elsayed, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Innovative Medicine at Johnson & Johnson, stated, "There remains an unmet need for early interventions and treatments that are both effective and well tolerated in people living with smoldering multiple myeloma at high-risk of progressing to active multiple myeloma. DARZALEX has changed the standard of care in multiple myeloma, and with these submissions to the FDA and EMA, this therapy could become the first approved treatment for patients with high-risk smoldering multiple myeloma, potentially shifting the treatment paradigm."
The first data from the AQUILA study were presented at the 2024 American Society of Hematology (ASH) Annual Meeting. The study evaluated the safety and efficacy of DARZALEX® FASPRO® compared to active monitoring in participants with high-risk smoldering multiple myeloma.
