Johnson & Johnson (NYSE: JNJ) has taken a significant step in expanding its oncology portfolio with a market filing to the European Medicines Agency (EMA) for its drug Darzalex (daratumumab). The application seeks an indication extension for the subcutaneous (SC) formulation of daratumumab, in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd), for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are not candidates for autologous stem cell transplant (ASCT).
The data supporting this submission stem from the Phase III CEPHEUS study, which demonstrated the D-VRd regimen’s superiority over the standard VRd therapy in terms of depth and durability of responses. The study’s primary endpoint, overall major molecular response rate (MRD-negativity rate) at a 10^-5 sensitivity, was significantly higher in the D-VRd group at 60.9% compared to 39.4% in the VRd group, with a median follow-up of 58.7 months (Odds Ratio [OR], 2.37; 95% confidence interval [CI], 1.58-3.55; p<0.0001) .
Moreover, the risk of disease progression or death was significantly reduced by 43% in the D-VRd group (Hazard Ratio [HR], 0.57; 95% CI, 0.41-0.79; p=0.0005) compared to the VRd group. The D-VRd regimen also achieved a higher overall complete response (CR) or better rate of 81.2% versus 61.6% with VRd (p<0.0001). The safety profile of D-VRd was found to be consistent with the known safety profiles of daratumumab and VRd, indicating that the addition of daratumumab to the regimen did not introduce new safety concerns .- Flcube.com
