Rytelo (imetelstat) / Geron 
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 144 Diseases   5 Trials   5 Trials   861 News 


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  • ||||||||||  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   
  • ||||||||||  imetelstat (GRN163L) / Geron
    Journal:  Telomerase-Targeted Therapies in Myeloid Malignancies. (Pubmed Central) -  May 22, 2023   
    We go on to discuss the development of telomere and telomerase targeted therapeutic candidates within the realm of myeloid malignancies. We overview all mechanisms of targeting telomerase that are currently in development with a particular focus on imetelstat, an oligonucleotide with direct telomerase inhibitory properties that has advanced the furthest in clinical development and has demonstrated promising data in multiple myeloid malignancies.
  • ||||||||||  imetelstat (GRN163L) / Geron, Evrenzo (roxadustat) / Astellas, AstraZeneca, FibroGen, Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
    Journal:  Novel Approaches and Future Directions in Myelodysplastic Syndrome Treatment. (Pubmed Central) -  May 21, 2023   
    For higher-risk MDS patients, hypomethylating agent monotherapy continues to be the standard of care. However, with various novel hypomethylating agent-based combination therapies in advanced clinical testing and an increased emphasis on individualized biomarker-driven treatment decisions, the standard therapy paradigms might change in the future.
  • ||||||||||  Rytelo (imetelstat) / Geron
    Trial initiation date:  IMpress: Study to Evaluate Imetelstat in Patients With High-Risk MDS or AML Failing HMA-based Therapy (clinicaltrials.gov) -  May 16, 2023   
    P2,  N=46, Not yet recruiting, 
    However, with various novel hypomethylating agent-based combination therapies in advanced clinical testing and an increased emphasis on individualized biomarker-driven treatment decisions, the standard therapy paradigms might change in the future. Initiation date: Dec 2022 --> May 2023
  • ||||||||||  imetelstat (GRN163L) / Geron, Evrenzo (roxadustat) / Astellas, AstraZeneca, FibroGen, Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
    Therapies of Anemia (Excluding MDS-RS Treatment) (Auditorium; Virtual) -  Apr 25, 2023 - Abstract #MDS2023MDS_81;    
    Luspatercept, a TGFbeta family ligand-trap induces nearly 50% of RBC transfusion independence in MDS with ring sideroblasts ( RS), but it has been shown to be active also in transfusion dependent non-RS LR MDS both in first line and after failure of ESA treatment. The telomerase inhibitor imetelstat has shown efficacy and disease modifying activity in LR MDS ESA refractory or relapsed, who did not receive lenalidomide or hypomethylating agents...Another approach has been represented by the oral hypoxia