Darzalex combination scheme first-line treatment AL amyloid degeneration phase III clinical reach the main endpoint

Currently, the FDA has not approved any treatment for light chain (AL) amyloid degeneration, but Darzalex Faspro, a Dartumab, johnson and johnson, has obtained positive data in a Phase 3 clinical trial, making it the first drug to be approved for the diseaseat the 25th annual meeting of the European Society of Hematology (EHA), Johnson and Johnson's Janssen Pharmaceuticals released data from darzalex's phase III trial called ANDROMEDAThe trial was conducted in newly diagnosed al-type amyloid degeneration patients and assessed the safety and effectiveness of Darzalex Faspro combined cyclophosphamide, boratizomi and desemezole (D-CyBorD) compared to CyBorDThe results showed that Darzalex Faspro combination therapy reached the primary endpoint of hematology complete remission rate (CR) (53% vs.18%, OR s 5.1, 95% CI - 3.2-8.2; P 0.0001), patients in the D-CyBorD treatment group had a higher overall hematologic response rate (92% vs.77%), and a better partial response rate (.VGPR; 79% vs.49%)Of the 195 patients in the D-CyBorD treatment group who had at least 195 cases with VGPR, the median time from treatment to reaching the median time of THE .VGPR/CR was 17 days/60 days, and the median time of 193 patients in the CyBorD group reached at least VGPR for 25/85 days6 months after treatment, the organ remission rate of patients in the D-CyBorD treatment group was almost double that of the CyBorD group, whether heart remission (42% vs22% ;P .0029) or kidney remission (54% vs.27% ;P 0.0001)In addition, MOD-PFS (HR-0.58; 95% CI, 0.36-0.93, P-EFS(HR-0.40; 95% CI, 0.28-0.57, P.0001) also supports Darzalex Faspro to improve severe organ deterioration, blood survival or deaththe tests, D-CyBorD showed the same safety as using Darzalex Faspro alone or CyBorD aloneAL amyloid degeneration is a rare and potentially fatal blood disease that affects the function of multiple organsSome of the plasma cells in patients with the disease overgenerate the light chains of immunoglobulins, causing them to be misfolded and aggregated to form fibers, accumulating inside and around the tissue, leading to extensive and increasing organ damageThe median survival of the diagnosed patients was less than 18 months, and the most common cause of death was heart failureAlthough there are currently a number of treatments for chemotherapy and self-contained stem cell transplantation, no approved treatments have been approved for organ damage caused by AL amyloid degenerationAs a result, new treatments are urgently needed for this deadly diseaseDaratumab can specifically identify CD38, which is highly expressed on multiple myeloma malignant plasma cells, in a high affinity manner, and then induce the death of tumor cells through a variety of immune media mediatemechanismsThe drug was first approved for market in November 2015 and has been approved in several countries around the world for first- and second-line, multi-line treatment of multiple myeloma In May and June of this year, the Darzalex subcutaneous injection (SC) formulation (brand name Darzalex Faspro) was approved by the United States and the European Union, becoming the first and only subcutaneous CD38 target antibody drug Reference Source: 1.Johnson and Johnson's Darzalex ix out of the field myeloma with al amyloidosis win 2.Subcutanth Yr®.