NEW BRUNSWICK (dpa-AFX) - Johnson & Johnson (JNJ) announced data highlighting that DARZALEX FASPRO (daratumumab and hyaluronidase-fihj)-based regimens improve overall and sustained minimal residual disease (MRD) negativity rates and progression-free survival (PFS) in patients with newly diagnosed multiple myeloma (NDMM), regardless of transplant status. The findings were demonstrated in an expanded MRD analysis of the Phase 3 CEPHEUS study and a post hoc analysis of clinically relevant subgroups in the Phase 3 AURIGA study.
The New analysis from Phase 3 CEPHEUS study demonstrated 85 percent of patients who achieved MRD negativity with DARZALEX FASPRO were progression free at 4.5 years. The Subgroup analysis from Phase 3 AURIGA study showed higher rates of MRD-negative conversion in patient populations disproportionately impacted by multiple myeloma.
According to the company, data from the expanded MRD analysis of the Phase 3 CEPHEUS study showed the addition of DARZALEX FASPRO to bortezomib, lenalidomide and dexamethasone (D-VRd) leads to improved and deepened rates of overall and sustained MRD negativity versus VRd alone, and shows significantly improved progression-free survival. CEPHEUS is the fifth Phase 3 study showing the addition of DARZALEX improves depth and duration of response, leading to improved progression-free survival.
In a post hoc analysis of the Phase 3 AURIGA study, an investigational maintenance regimen of DARZALEX FASPRO combined with lenalidomide resulted in consistently improved MRD-negative conversion rates after 12 months. These results were consistent across anti-CD38 naïve patient subgroups who were MRD-positive post-autologous stem cell transplant (ASCT). In patients older than 65 years, MRD-negative rates were higher when treated with D-R maintenance therapy compared to R alone. Maintenance therapy with D-R showed a consistently higher conversion to MRD negativity in Black patients compared to R alone and white patients.
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