Results of darzale clinical study significantly prolonged PFS in MM patients

The results showed that in the newly diagnosed MM patients who met the conditions of ASCT, compared with the standard therapy of bortezomib + thalidomide + dexamethasone (VTD), adding darzalex to VTD before and after transplantation improved the remission rate and prolonged the progression free survival (PFS)< br / > Cassiopeia is a randomized, open label, multicenter study involving 1085 newly diagnosed MM patients who are eligible for high-dose chemotherapy and stem cell transplantationIn the first part of the study, patients were randomly divided into two groups, receiving VTD or darzalex + VTD induction therapy, high-dose chemotherapy and ASCT, VTD or darzalex + VTD consolidation therapyThe main end point was the proportion of patients who achieved strict complete remission (SCR)Patients who achieved partial remission or better remission entered the second part of the study< br / > at present, the second part of the study is in progressIn this part of the study, patients are randomly divided into two groups, or receive darzalex (16 mg / kg, once every 8 weeks) maintenance treatment until two years, or only observe no further treatment, the main end point is PFS< br / > the results of the first part of the study showed that after the consolidation treatment, compared with VTD group, the proportion of patients in darzalex + VTD group who achieved SCR was significantly increased (29% vs 20%; or = 1.60, 95% CI: 1.21-2.12, P < 0.0010)After a median follow-up of 18.8 months, PFS was significantly prolonged in darzalex + VTD group (HR = 0.47, 95% CI: 0.33-0.67, P < 0.0001), but not in both groupsThe PFS rate was 93% in darzalex + VTD group and 85% in VTD group< br / > compared with VTD group, darzalex + VTD group had a higher proportion of patients who achieved very good partial or better remission (83% vs 78%; or = 1.41; 95% CI: 1.04-1.92; P = 0.0239), complete or better remission (39% vs 26%; or = 1.82; 95% CI: 1.40-2.36, P < 0.0001), and slight residual disease negative (sensitivity threshold 10-5: 64% vs 44%)< br / > in terms of safety, the most common (≥ 10%) 3 / 4 adverse events in darzalex + VTD group and VTD group were neutropenia (28% vs 15%), lymphopenia (17% vs 10%), stomatitis (13% vs 16%), thrombocytopenia (11% vs 7%)In the darzalex + VTD group, 35% of patients had transfusion related reactions< br / > based on the above research results, Yang Sen has submitted darzalex's application for new indications to the US FDA and EU EMA in March this year, and combined with standard therapy to treat the newly diagnosed MM patients who meet the transplant conditions< br / > darzalex is the first approved anti-CD38 mediated and cytolytic antibody drug in the worldIt has broad-spectrum killing activity, and can target CD38 molecule which is highly expressed on the surface of multiple myeloma and multiple solid tumor cellsIn addition, darzalex has also been proved to be able to target immunosuppressive cells in tumor microenvironment to show immunoregulatory activity < br / > darzalex is a product vigorously developed by Johnson & Johnson It has been approved to treat newly diagnosed mm, second-line mm and multi line mm that do not meet the transplantation conditions in the first-line treatment In addition, the drug has the potential to treat other types of tumors with high expression of CD38, including diffuse large B-cell lymphoma, chronic lymphoblastic leukemia, acute lymphoblastic leukemia, plasmacytic leukemia, acute myeloid leukemia, follicular lymphoma and nested lymphoblastoma < br / > in 2018, darzalex's global sales reached US $2.025 billion, up 63.0% year on year Evaluatepharma forecasts that darzalex's global sales will reach US $6.033 billion in 2024, which will become a key product to drive the future growth of Johnson & Johnson < br / > reference source: study investigating darzalex ® (daratomab) shows improved depth of response and progress free survival in patients with newly diagnosed multiple myeloma who are elite for a transplant