US healthcare conglomerate Johnson & Johnson (J&J, NYSE: JNJ) has presented results from several clinical studies for its Darzalex Faspro (daratumumab and hyaluronidase-fihj) at the 2024 American Society of Hematology (ASH) annual meeting. Darzalex Faspro, a CD38-directed antibody co-formulated with Halozyme’s ENHANZE drug delivery technology, has shown promising results in the treatment of multiple myeloma (MM).
Darzalex Faspro’s Mechanism of Action
Darzalex Faspro can recognize CD38, which is highly expressed on MM malignant plasma cells, with high affinity and specificity, inducing tumor cell death through various immune-mediated mechanisms. The co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) enhances the drug’s delivery and absorption.
Phase III AQUILA Study Results
The AQUILA study demonstrated that Darzalex Faspro significantly delayed the progression of high-risk asymptomatic smoldering multiple myeloma (SMM) to active MM, and prolonged progression-free survival (PFS) and overall survival (OS), indicating an advantage over the current standard management protocol of active monitoring. J&J used these results to file for another indication approval in the US and European Union (EU) for the treatment of high-risk asymptomatic MM.
Phase III AURIGA Study Findings
The AURIGA study showed that in newly diagnosed multiple myeloma (NDMM) patients with minimal residual disease (MRD) positive after first-line autologous stem cell transplantation (ASCT), Darzalex Faspro combined with lenalidomide as a maintenance therapy for 12 months significantly improved the negative rate of MRD compared to lenalidomide alone. Notably, patients aged 65 and above receiving the combination therapy achieved an MRD negative rate as high as 52.6%, compared to 17.5% in the control group.
Phase III CEPHEUS Study Outcomes
The CEPHEUS study indicated that in newly diagnosed MM patients not suitable for transplantation or not planning to undergo initial transplantation, the combination of Darzalex Faspro and D-VRd significantly improved the overall and sustained MRD negative rate and significantly prolonged PFS compared to lenalidomide, bortezomib, and dexamethasone (VRd).
Phase III ANDROMEDA Study Achievements
The ANDROMEDA study showed that in newly diagnosed adult patients with amyloid light chain (AL) amyloidosis, the combination of Darzalex Faspro and D-VCd accelerated and deepened hematological remission, significantly improving OS and PFS of organ dysfunction compared to bortezomib, cyclophosphamide, and dexamethasone (VCd).-Fineline Info & Tech
