Johnson & Johnson (J&J) has submitted regulatory applications in the EU and US for the use of its CD38-directed antibody Darzalex (daratumumab) in smouldering multiple myeloma (SMM), an early precursor of active multiple myeloma (MM).
The company is seeking approval of subcutaneous (SC) Darzalex, also known as Darzalex Faspro, as a monotherapy for adults with high-risk SMM from the European Medicines Agency (EMA) and US Food and Drug Administration (FDA).
More than 35,000 people are expected to be diagnosed with MM in the US this year, with SMM accounting for 15% of all newly-diagnosed cases.
SMM is not generally treated until active MM develops. However, recent evidence has suggested that patients at high-risk for progression to active MM could benefit from earlier therapeutic intervention.
The Darzalex applications are supported by positive results from the ongoing phase 3 AQUILA trial, which is comparing J&J’s drug against active monitoring in 390 SMM patients at high risk of progression.
The data is set to be presented at this year’s American Society of Hematology Annual Meeting in December and, according to an abstract of the trial, PFS significantly improved with SC Darzalex.
At a median follow-up of 65.2 months, median progression-free survival (PFS) was not reached in the SC Darzalex group versus 41.5 months for active monitoring, with an estimated 60-month PFS rate of 63.1% versus 40.8%, respectively.
The drug also reduced the risk of progressing onto first-line MM treatment, with 33% of patients in the SC Darzalex group and 52% of those in the active monitoring group having started first-line MM treatment at the clinical cutoff.
Yusri Elsayed, global therapeutic area head, oncology, innovative medicine, J&J, said: “There remains an unmet need for early interventions and treatments that are both effective and well tolerated in people living with SMM at high-risk of progressing to active disease.
“Darzalex has changed the standard of care in MM, and with these submissions to the FDA and EMA, this therapy could become the first approved treatment for patients with high-risk SMM, potentially shifting the treatment paradigm.”