Johnson & Johnson has released data demonstrating the efficacy of DARZALEX FASPRO (a combination of daratumumab and hyaluronidase-fihj) in improving both overall and sustained minimal residual disease (MRD) negativity rates, as well as progression-free survival (PFS) in patients newly diagnosed with multiple myeloma, applicable irrespective of transplant eligibility. These insights were gleaned from an expanded MRD analysis within the Phase 3 CEPHEUS study and a post hoc exploration of pertinent subgroups within the Phase 3 AURIGA study.
The Phase 3 CEPHEUS study revealed that a remarkable 85% of patients achieving MRD negativity with DARZALEX FASPRO remained progression-free over a 4.5-year period. Moreover, subgroup analysis within the Phase 3 AURIGA study indicated heightened MRD-negative conversion rates among populations disproportionately affected by multiple myeloma.
The company reports that the expanded MRD analysis in the Phase 3 CEPHEUS study indicates that incorporating DARZALEX FASPRO with bortezomib, lenalidomide, and dexamethasone (D-VRd) significantly enhances overall and sustained MRD negativity rates, compared to using VRd alone, while also markedly improving progression-free survival. Notably, CEPHEUS stands as the fifth Phase 3 trial affirming that the addition of DARZALEX enhances the depth and longevity of response, culminating in better progression-free survival outcomes.
Furthermore, the Phase 3 AURIGA study's post hoc analysis noted that an investigational maintenance regimen combining DARZALEX FASPRO and lenalidomide consistently led to improved MRD-negative conversion rates after 12 months across diverse CD38-naive patient subgroups who were initially MRD-positive following autologous stem cell transplant (ASCT). For individuals over 65, MRD-negative rates were highest with DARZALEX FASPRO maintenance therapy compared to lenalidomide alone. Additionally, this maintenance therapy exhibited a consistently higher MRD negativity conversion rate among Black patients in contrast to treatment with lenalidomide alone and compared to white patients.
