Johnson & Johnson (J&J) has announced that its CD38-directed antibody Darzalex (daratumumab) has been approved by the European Commission (EC) to treat adults with smouldering multiple myeloma (SMM), an early precursor of active multiple myeloma (MM).
A subcutaneous (SC) formulation of the drug has been authorised by the regulator as a monotherapy for SMM patients at high-risk of developing MM, making it the first licensed treatment for this patient population.
It is estimated that over 35,000 people in Europe were diagnosed with MM, a blood cancer that affects a type of white blood cell called plasma cells, in 2022.
SMM accounts for around 15% of all new cases of the disease and 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.
Already approved in the EU for a range of MM indications and AL amyloidosis, Darzalex is designed to attach to the CD38 protein, present in a high numbers on MM cells, and inhibit tumour cell growth.
The EC’s latest decision was based on results from the phase 3 AQUILA trial, which compared the drug against active monitoring in 390 SMM patients at high risk of progression.
At a median follow-up of 65.2 months, Darzalex SC-treated patients showed statistically significant improved progression-free survival (PFS) compared to patients who underwent active monitoring. Among patients who were retrospectively categorised as having high-risk SMM, median PFS was not reached in the Darzalex cohort and was 22.1 months in the active monitoring arm.
Darzalex SC, which is co-formulated with Halozyme’s ENHANZE drug delivery technology, also extended overall survival, with five-year survival rates of 93% versus 86.9% for active monitoring, and patients treated with J&J’s drug saw a higher overall response rate.
Jordan Schecter, vice president, disease area leader, MM, J&J Innovative Medicine. “With [this] approval, J&J has an innovative therapy for every stage of the disease.
“We can now offer physicians and patients the option to treat with [Darzalex] earlier, significantly delaying progression and the need for more intensive, continuous therapy, as well as extending overall survival.”