FDA approval of Darzalex + bortezomib + thalidomide and dexamethasone for multiple myeloma patients who are eligible for autologous stem cell transplant. Janssen Biotech

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the FDA approval of Darzalex (daratumumab) in combination with bortezomib (Velcade), thalidomide and dexamethasone (VTd) for newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplant (ASCT). The approval is based on results from the Phase III CASSIOPEIA (MMY3006) study that showed the addition of Darzalex to VTd before and after ASCT resulted in deeper responses, as indicated by the higher stringent complete response (sCR) rate, and improved progression-free survival (PFS) compared to VTd alone.

Data from the Phase III CASSIOPEIA study were first presented at the 2019 American Society of Clinical Oncology Annual Meeting and simultaneously published in The Lancet. Additionally, updates from the study were recently presented at the 17th International Myeloma Workshop Meeting. CASSIOPEIA is a two-part, Intergroupe Francophone du Myelome (IFM) study in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and Janssen Research & Development, LLC. Results from this first part of the trial showed that the primary endpoint of sCR rate post consolidation was significantly higher in the Darzalex-VTd arm compared to VTd alone (29 percent vs. 20 percent) (Odds Ratio [OR] = 1.60; 95 percent confidence interval [CI], 1.21�2.12; P=0.0010). The addition of Darzalex to VTd at a median follow-up of 18.8 months resulted in a 53 percent reduction in the risk of disease progression or death compared to VTd alone (Hazard Ratio [HR] = 0.47; 95 percent CI, 0.33�0.67; P<0.0001). after consolidation darxzalex vtd also increased the rate of complete response or better 39 percent vs. 26 percent or="1.82;" 95 percent ci 1.40-2.36 and very good partial response or better 83 percent vs. 78 percent or="1.41;" 95 percent ci 1.04-1.92 compared to vtd alone respectively.the most frequent adverse reactions>20 percent with at least 5 percent greater frequency in the Darzalex-VTd group) were infusion reactions, nausea, pyrexia, upper respiratory tract infection and bronchitis.1 Serious adverse reactions with a 2 percent greater incidence in the Darzalex -VTd arm compared to the VTd arm were bronchitis (2 percent vs. <1 percent and pneumonia 6 percent vs. 4 percent respectively.1 in the darzalex-vtd combination arm infusion-related reactions occurred in 35 percent of patients.>

See- "Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA): a randomised, open-label, phase III study- Philippe Moreau, MD Michel Attal, MD Cyrille Hulin, MD et al Published:June 03, 2019DOI:https://doi.org/10.1016/S0140-6736(19)31240-1.