Rytelo (imetelstat) / Geron 
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 144 Diseases   5 Trials   5 Trials   837 News 


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  • ||||||||||  Rytelo (imetelstat) / Geron
    Review, Journal:  Obesity-Senescence-Breast Cancer: Clinical Presentation of a Common Unfortunate Cycle. (Pubmed Central) -  Sep 20, 2024   
    In this review, interlinked molecular mechanisms are looked over between the telomere length, lipotoxicity/glycolipotoxicity, and cellular senescence in the context of estrogen receptor alpha-positive (ER?+) postmenopausal breast cancers in obese women. Furthermore, the effect of the potential drugs, which are used for direct inhibition of telomerase and the inhibition of human telomerase reverse transcriptase (hTERT) or human telomerase RNA promoters as well as approved adjuvant endocrine therapies, the selective estrogen receptor modulator and selective estrogen receptor down-regulators are discussed.
  • ||||||||||  Progress in Lower-Risk MDS () -  Aug 30, 2024 - Abstract #SOHO2024SOHO_1041;    
    Roxadustat, an oral HIF1- alpha hydroxylase inhibitor, was approved for treating anemia in Europe and China for chronic renal insufficiency...Both romiplostim and eltrombopag are approved for treating immune thrombocytopenic purpura, but their use in LR- MDS is still off label...Conclusions Significant progress has been obtained in treating anemia in LR- MDS, but there is still room for improvement by building a strategy to optimize the sequence of therapies with agents with different mechanisms of action and by evaluating combinations of them to achieve long-lasting TI. Target therapies like ivosidenib, a mutant IDH1 inhibitor, could be a candidate for LR-MDS cases with this mutation, as suggested by pivotal studies.
  • ||||||||||  Rytelo (imetelstat) / Geron
    Review, Journal:  Imetelstat: First Approval. (Pubmed Central) -  Aug 20, 2024   
    In June 2024, imetelstat was approved in the USA for use in adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring 4 or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA). This article summarizes the milestones in the development of imetelstat leading to this first approval for the treatment of adult patients with low- to intermediate-1 risk MDS with transfusion-dependent anemia.
  • ||||||||||  Rytelo (imetelstat) / Geron
    Journal:  Imetelstat Sodium. (Pubmed Central) -  Aug 12, 2024   
    This article summarizes the milestones in the development of imetelstat leading to this first approval for the treatment of adult patients with low- to intermediate-1 risk MDS with transfusion-dependent anemia. No abstract available
  • ||||||||||  Rytelo (imetelstat) / Geron, Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
    Review, Journal:  Treatment of Anemia in Lower-Risk Myelodysplastic Syndrome. (Pubmed Central) -  Jul 3, 2024   
    For those without previous luspatercept exposure it can be considered particularly if there is an SF3B1 mutation or the presence of ring sideroblasts. Other options include HMAs or IST; the Phase III IMERGE trial supports the efficacy of the telomerase inhibitor imetelstat in this setting and this may become a standard option in the future as well.
  • ||||||||||  Rytelo (imetelstat) / Geron
    Enrollment closed, Enrollment change:  IMpress: Study to Evaluate Imetelstat in Patients With High-Risk MDS or AML Failing HMA-based Therapy (clinicaltrials.gov) -  Jun 12, 2024   
    P2,  N=23, Active, not recruiting, 
    Other options include HMAs or IST; the Phase III IMERGE trial supports the efficacy of the telomerase inhibitor imetelstat in this setting and this may become a standard option in the future as well. Recruiting --> Active, not recruiting | N=46 --> 23
  • ||||||||||  imetelstat (GRN163L) / Geron, Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
    Review, Journal:  Phase to phase: Navigating drug combinations with hypomethylating agents in higher-risk MDS trials for optimal outcomes. (Pubmed Central) -  Jan 22, 2024   
    Effective therapeutic strategies require accurate reporting of adverse events, highlighting the need for clarity in criteria like the Common Terminology Criteria for Adverse Events (CTCAE). We provide an overview on negative clinical trials in HR MDS, analyze possible reasons and explore possibilities to optimize future clinical trials in this challenging patient population.
  • ||||||||||  imetelstat (GRN163L) / Geron
    Impact of Mutational Status on Clinical Response to Imetelstat in Patients with Lower-Risk Myelodysplastic Syndromes in the IMerge Phase 3 Study (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_6051;    
    P2/3
    While the sample size for specific mutations was small, consistent with the observation that patients with LR-MDS have a low number of specific mutations, TI responses in patients receiving imetelstat occurred regardless of the presence of mutations associated with poor prognosis or the number of mutations. Imetelstat showed comparable TI rates across different molecularly defined subgroups, suggesting that clinical benefit of imetelstat in patients with LR-MDS is independent of the underlying molecular pattern.
  • ||||||||||  etavopivat (NN7535) / Novo Nordisk
    FORTITUDE: A Phase 2 Open-Label Study in Progress to Evaluate Etavopivat for the Treatment of Anemia in Patients with Lower-Risk Myelodysplastic Syndromes (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_4187;    
    P2
    Erythropoiesis-stimulating agents and other drugs, including lenalidomide, luspatercept and imetelstat (an investigational product), can lead to RBC transfusion independence and improve Hb levels in many patients; however, responses are generally transient and novel treatments are needed for this population...Additional exclusion criteria include prior treatment with azacitidine; decitabine; erythropoietin, other hematopoietic growth factor treatment or lenalidomide within 30 days of Day 1 or anticipated to be required during the study; and luspatercept within 30 days of Day 1 for NTD patients and within 16 weeks of Day 1 for TD patients...Summary : Etavopivat is a novel, investigational, once-daily, selective PKR activator with the potential to improve RBC health and lifespan. This phase 2 study will assess the safety of etavopivat and its impact on Hb levels and RBC transfusion burden in patients with LR-MDS and anemia.
  • ||||||||||  imetelstat (GRN163L) / Geron, Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
    Hematological Response to Frontline Treatment in Lower Risk Myelodysplastic Syndromes (LRMDS) Is Associated with Better Overall Survival (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_2293;    
    In lieu of 2 recent randomized clinical trials demonstrating efficacy of luspatercept & imetelstat in LRMDS, we assessed the impact of response to sequential lines of treatment in LR-MDS on overall survival (OS) to guide our treatment choices and to determine whether erythroid stimulating agents (ESA) should still be our 1 st line of therapy...331 pts (55%) received SL which included HMA 43% (n= 142), lenalidomide 39% (n=130), luspatercept 7% (n=24), ATG 2% (n=8), investigational agent 4% (n=14), and other 4% (n=13)...Responses beyond SL were rarely observed. Identifying and moving agents with high HI rate as FL therapy and or selecting option based on predictors of best chance of response to a specific treatment as FL may lead to better overall survival.
  • ||||||||||  Review, Journal:  Management of Patients with Lower-Risk Myelodysplastic Neoplasms (MDS). (Pubmed Central) -  Aug 1, 2023   
    Several newer agents are being evaluated in phase 3 clinical trials for this group of patients, such as imetelstat and oral azacitidine. This review provides a summary of the classification systems, the prognostic scores and clinical management of patients with lower risk MDS.
  • ||||||||||  imetelstat (GRN163L) / Geron
    Imetelstat (Twitter) -  Jul 4, 2023