Reblozyl (luspatercept-aamt) / BMS, Merck (MSD) 
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 2 Diseases   40 Trials   40 Trials   1659 News 


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  • ||||||||||  Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
    Review, Journal:  Luspatercept: A New Tool for the Treatment of Anemia Related to β-Thalassemia, Myelodysplastic Syndromes and Primary Myelofibrosis. (Pubmed Central) -  Oct 25, 2022   
    It has shown efficacy in the treatment of anemia due to beta β-thalassemia, MDS and PMF and recently gained approval by the Federal Drug Agency (FDA) and the European Medicines Agency (EMA) for transfusion-dependent (TD) patients with β-thalassemia and very low to intermediate-risk patients with MDS with ringed sideroblasts who have failed to respond to, or are ineligible for, an erythropoiesis-stimulating agent. In this review, we describe the key pathways involved in normal hematopoiesis and the possible mechanism of action of luspatercept, present its development and data from the most recent clinical trials in β-thalassemia, MDS and PMF, and discuss its potential use in the treatment of these hematological disorders.
  • ||||||||||  Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
    Review, Journal:  Novel Therapies for Unmet Clinical Needs in Myelodysplastic Syndromes. (Pubmed Central) -  Oct 15, 2022   
    Several drugs are under evaluation for LR and HR patients, which differ by their mechanism of action, reported efficacy, and phase of development. This review analyzes the current unmet clinical needs for MDS patients and provides a critical overview of the novel agents under development in this setting.
  • ||||||||||  Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
    Journal:  New treatment for myelodysplastic syndromes: luspatercept and oral hypomethylating agents (Pubmed Central) -  Oct 13, 2022   
    A combination of oral decitabine with oral cedazuridine, an inhibitor of cytidine deaminase, which metabolizes decitabine, demonstrated pharmacological equivalence with intravenous decitabine and has overall response rates of 60% and 43% for high-risk MDS in phase 2 and 3 trials, respectively. Furthermore, oral azacitidine and its combination with oral cedazuridine have been under development.
  • ||||||||||  sotatercept (MK-7962) / BMS, Merck (MSD), Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
    Journal:  Detection of activin receptor type IIA and IIB-Fc fusion proteins by automated capillary immunoassay. (Pubmed Central) -  Oct 7, 2022   
    The recent approval of Luspatercept for the treatment of anemia associated to transfusion-dependent MDS and Beta-thalassemia in afflicted patients means that it can now pose a real threat of being abuse in sport for its ability to stimulate erythropoiesis...The option to use different antibodies allows the possibility to use this method as an initial testing procedure as well as a confirmation procedure. Finally, results coming from an administration study confirm that the method is suitable for routine analysis.
  • ||||||||||  Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
    Journal:  Luspatercept in patients with non-transfusion dependent β-thalassaemia. (Pubmed Central) -  Oct 4, 2022   
    Luspatercept represents a potential treatment for adult patients with non-transfusion-dependent β-thalassaemia, for whom effective approved treatment options are scarce. No abstract available
  • ||||||||||  Immune Therapy Approaches in MDS (Level 4, Grand Ballroom G-L) -  Jul 26, 2022 - Abstract #SOHO2022SOHO_65;    
    Its aberrant expression on leukemic blasts stem cells (LSCs) and blasts but not on that of normal hematopoietic stem cells make this an attractive therapeutic target.5,6 Binding of the high affi nity anti-TIM3 IgG4 antibody sabatolimab to TIM3 results in phagocytic killing of LSCs and blasts and in combination with DNMT inhibitors have demonstrated safety, minimal immune toxicity and importantly early evidence of durable remissions in the phase 1b setting.7 Toxicities were predominantly expected cytopenias and mild GI intolerance (constipation, nausea)...An on-going phase 1/2 trial is evaluating tagraxofusp monotherapy in chronic myelomonocytic leukemia (N=38) reported tolerability including a 21% capillary leak syndrome (CLS) rate (11% grade 2 and 11% grade 3) and encouraging median overall survival of 15.6 months (95% CI, 8.1-17.5; range, 0.36-40.77).11 Based on strong preclinical evidence demonstrating tagraxofusp resistance was due to decreased expression of DPH1 which could be restored with azacitidine, a phase 1b trial of azacitidine and tagraxofusp in MDS/AML was launched...Targeting immunological dysfunctional pathways is a well-studied approach in MDS with prior successes with immunosuppressive therapies (ATG), immunomodulatory agents such as lenalidomide in 5q deletion MDS and luspatercept which limits TGF-beta signaling...Notably, among 7 patients with splicing mutated higher risk MDS there was 57% marrow CR rate including 1 with HI.15 This trial has plans to assess CA-4948 in combination with azacitidine or venetoclax...It remains a challenge to interpret small single arm studies and mixing populations that are truly resistant (HMA refractory) and treatment naïve, and different formulations of the same class of drugs and thus reliance on large phase 2/3 trials and importantly randomized trials will be most informative. A focus on identifying select disease subpopulations in these early trials (‘signal fi nding’ i.e. magrolimab with TP53 mutations or splicing mutations with IRAK4 inhibition) is an opportunity we cannot afford to miss.
  • ||||||||||  Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
    Trial primary completion date:  Study of Safety & PK of Luspatercept (ACE-536) in Pediatric Participants With Beta (?)-Thalassemia (clinicaltrials.gov) -  May 27, 2022   
    P2a,  N=54, Recruiting, 
    Subsequently, we review agents that target those areas of unmet need, focusing specifically on the JAK inhibitors, momelotinib, pacritinib, itacitinib, and NS-018 as well as JAK inhibitor combination approaches using CPI-0610, navitoclax, parsaclisib, and luspatercept. Trial primary completion date: Dec 2025 --> Feb 2031
  • ||||||||||  Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
    Enrollment open, Trial completion date, Trial initiation date, Trial primary completion date:  Study Evaluating Combination of Luspatercept in LR-MDS Without RS Having Failed or Being Ineligible to ESA (clinicaltrials.gov) -  May 20, 2022   
    P1/2,  N=150, Recruiting, 
    Trial primary completion date: Dec 2025 --> Feb 2031 Not yet recruiting --> Recruiting | Trial completion date: Aug 2027 --> Nov 2027 | Initiation date: Feb 2022 --> May 2022 | Trial primary completion date: Feb 2027 --> May 2027