Light chain (AL) amyloid degeneration first therapy! Johnson and Johnson subcutaneous Darzalex combination first-line therapy Phase III Clinical: Hematology remission rate as high as 92%

June 14, 2020 /PRNewswire/ -- Janssen Pharmaceuticals, owned by Johnson and Johnson (JNJ), recently announced the positive results of the Phase III ANDROMEDA study at the 25th annual meeting of the European Society of Haematology (EHA)The study was the first random phase III study to investigate subcutaneous injection of Darzalex (megaphonosis ®, generic name: daratumumab, daretou monomaatagain) first-line treatment of newly diagnosed patients with light chain (AL) amyloid degeneration, and the data showed that the data showed that the data were associated with cyclophosphamide and botimizomi Compared to the CyBorD programme, Darzalex-cyclophosphamide-boronyzomi-D-Cysemison (D-CyborD) resulted in a higher hematologic total remission rate (CR: 53% vs 18%, p 0.0001)In addition, the D-CyBorD programme extends progression-free survival (MOD-PFS) of critical organs and event-free survival (MOD-EFS) compared to the CyBorD schemeIn the study, the safety of combination drugs was consistent with that of subcutaneous injections of Darzalex or CyBorDLight chain (AL) amyloid degeneration is a rare and potentially fatal multisystem disease that occurs when the bone marrow produces abnormal antibody fragments called light chains (AL), which gather together to form amyloidThese amyloid proteins are deposited in tissues and vital organs, interfering with normal organ functionWith the development of disease, many patients have a number of organs such as the heart, kidneys, digestive tract, liver and nervous system gradually degenerativeThe diagnosis of AL amyloid degeneration is often delayed and the prognosis is poor due to the later stages of multiple organs (especially the heart)The median survival of AL amyloid patients is estimated to be between 6 months and 3 years, depending on the patient population and the data usedCurrently, there are no approved treatments for this devastating diseaseANDROMEDA (NCT03201965) is an ongoing random, open-label Phase III study that is investigating the efficacy and safety of undercut injections darzalex in conjunction with CyBorD to treat newly diagnosed AL amyloid degeneration patientsThe study involved 388 patients newly diagnosed with AL amyloid degeneration with measurable hematology disorders affecting one or more organsThe primary endpoint is the overall total hematological remission rate (intentional therapy/ITT)Secondary endpoints include major organ deterioration without progression survival (MOD-PFS), eventless survival (EFS), organ remission rate, total survival (OS), and hematologic remission timeThe results showed that in terms of primary end-point hematologic total remission rate (CR), the D-CyBorD group was 53% and the CyBorD group was 18% (the ratio of the ratio of the ratio of the main end point hematologic (CR), the ratio of the ratio to the ratio of the number of hematology (CR), the ratio of the ratio of the ratio to the number of the main end point, the total remission rate (CR), the ratio of the ratio of the ratio of the total relief rate (CR), the ratio of the ratio of the ratio of the ratio of the total relief rate (CR), and the p 0.0001In addition, the D-CyBorD group had a higher total hematologic remission rate (92% vs 77%) and a very good partial or better rate of remission (.VGPR: 79% vs 49%) compared to the CyBorD groupOf the 195 patients in the D-CyBorD group who had at least 195 cases with a condition of VGPR, the median time from treatment to the median of the group reached VGPR/CR was 17 days/60 days, while in 193 patients with the CyBorD group with at least VGPR, the median time from treatment to the median time of the stiletto s.VGPR/CR was 25 days/85 days The 6-month organ remission rate, almost double that of the CyBorD group, included: heart remission rate (42% vs 22% ;p x 0.0029) and kidney remission rate (54% vs 27% ;p 0.0001) In addition, MOD-PFS (risk ratio of .58; 95% CI: 0.36-0.93, p-0.0224) and MOD-EFS (HR-0.40; 95% CI:0.28-0.57, p 0.0001) are conducive to significantly delayed major organ deterioration, survival or progression in the blood In addition, Darzalex in the D-CyBorD group administered the drug through subcutaneous injections, which help limit intravenous fluid overload, which is an important therapeutic factor in heart-affected patients In the study, the most common adverse events occurred during the D-CyBorD group of 5% patients (TEAE, compared to the CyBorD group) included: lymphocyte reduction (13% vs 10%), pneumonia (8% vs 4%), diarrhea (6% vs 4%), heart failure (6% vs 5%), reduction of neutral granulecells (5% vs 3%), fainting (5% vs vs 6%) Studies have shown that the incidence of drug-related reactions (ARR) for subcutaneous injection of Darzalex is low In 14 cases (7%) of the D-CyBorD group, systemic ARR occurred, both at levels 1-2, mostofly during the initial administration A total of 56 deaths were found in the study (D-CyBorD group, n?27; CyBorD group, n?29) "AL amyloid patients often experience poor results because their symptoms are confused with more common conditions, leading to delays in diagnosis," said Raymond L Comenzo, the study's study's study's director of John C Davis myeloma and amyloid project at Tufts Medical Center In the AL amyloid degeneration population, the treatment of newly diagnosed patients is the most challenging, with many patients not achieving second-line treatment In the ANDROMEDA study, patients treated with subcutaneous Darzalex had a higher rate of complete remission and significantly maintained major organ function, suggesting that subcutaneous Darzalex may be a promising treatment for newly diagnosed AL amyloid degeneration patients These patients are in urgent need of new treatment options "There is an urgent need to provide promising treatments for patients diagnosed with this rare, difficult-to-treat disease because they do not have approved treatment options," said Dr Jessica Vermeulen, Global Medical Director/Clinical Director of Hematology and Oncology at Jansen Research Our goal is to offer new hope for the treatment of AL amyloid degenerative patients We are encouraged by the results of Darzalex, an anti-CD38 monoclonal antibody that treats multiple myeloma, and we look forward to submitting regulatory applications to regulators based on the results of the ANDROMEDA study "Darzalex (Mega®, Daretou monosar): China's first CD38 targeted monosar, re-defined myeloma treatment in China, Darzalex (Mega®, Daretoyu monosar) intravenous (IV) preparation in 201 Approved for market in October 19, the drug is intended for single-drug treatment of patients with recurrent and refractory multiple myeloma (MM) adults, specifically in patients who have previously been treated with treatment including protease inhibitors and immunomodulators and developed disease progression during the last treatment As China's first approved CD38 monoclonal antibody-targeted drug, the innovative program is expected to define the treatment of multiple myeloma in the country Darzalex is the world's first approved CD38 mediated, solute antibody drug with broad-spectrum anti-personnel activity, can target trans-diaphytic extinase CD38 molecules combined with multiple myeloma and a highly expressed surface of multiple solid tumor cells, through a variety of immunomediated The mechanisms of action induce rapid death of tumor cells, including complementary-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicaction (ADCC) and antibody-dependent cell phagocytosis (ADCP), and apoptosis through apoptosis In addition, Darzalex has been shown to exhibit immunomodulation activity by targeting immunosuppressive cells in tumor microenvironments Darzalex was first approved for public offering in November 2015 and has sales of $2,998 million in 2019 At present, the drug has been approved by several countries around the world for first-line, second-line, multi-line treatment of multiple myeloma, specifically approved indications vary from country to country, including: (1) November 2015, as a single drug therapy, used in the past has been accepted at least 3 therapies (including a protease inhibitor (PI) and an immunomodulator (IMiD)) or mm adults with dual incurability to PI and immunomodulators; Domine and dexamethasone, or combined boratizomand and dexamethasone, were used in MM adult patients who had previously received at least one treatment; MM adult patients who have received at least two treatments, including indomine and PI; (4) may, in May 2018, co-boratim, melphalan and prednisone, For newly diagnosed MM adult patients who are not suitable for an indoctrisal stem cell transplant (ASCT), this approval makes Darzalex the first monoantithing drug approved for the treatment of newly diagnosed MM (5) In June 2019, a combination of nadoamine and dexamethasone for use in newly diagnosed MM adult patients not suitable for ASCT (6) In September 2019, combined boratizomi, thalidomide and dexamethasone were used for new ADULT patients with ASCT, making Darzalex the first biological agent approved for use in newly diagnosed MM patients eligible for ASCT In February 2019, darzalex's sub-dosing program was approved by the U.S FDA The program will allow healthcare professionals to choose as needed when treating MM patients, dividing Darzalex's first intravenous infusion from a single one-time infusion into two consecutive days of intravenous infusions In May and June of this year, the Darzalex subcutaneous injection (SC) agent was approved by the United States (brand name Darzalex Faspro) and the European Union, becoming the first and only subcutaneous CD38 target antibody drug Darzalex SC is administered in a fixed dose, by subcutaneous injection, in just 3-5 minutes The IV preparation, on the other hand, is administered intravenously and usually takes several hours The approval of the SC preparation marks an important milestone in the positive change in the lives of MM patients who rely on Darzalex for treatment (BioValleyBioon.com) Original source: Subcutan Daratumab Combine Resulted in Deep and Rapid Hematologic Responses and Improved Clinical Outcomes in The Treatment of Patients with New New New Ed New Ed Light Chain (AL) Amyloidosis