Elzonris (tagraxofusp-erzs) / Menarini 
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 17 Diseases   11 Trials   11 Trials   835 News 


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  • ||||||||||  Elzonris (tagraxofusp) / Menarini
    Journal:  Tagraxofusp and anti-CD123 in blastic plasmacytoid dendritic cell neoplasm: a new hope. (Pubmed Central) -  Dec 16, 2020   
    Further studies are required to resolve many several unanswered questions about tagraxofusp. In this review, we will resume and discuss pharmacological characteristic of tagraxofusp, results of clinical trials leading to its approval by FDA in 2018 and future perspectives about its use in BPDCN and other hematological malignancies.
  • ||||||||||  Elzonris (tagraxofusp) / Menarini
    [VIRTUAL] A Case of a Patient with Two Rare Histiocytic Neoplasms () -  Dec 2, 2020 - Abstract #ASDP2020ASDP_431;    
    He developed hepatosplenic progression during induction with tagraxofusp (CD123-directed therapy of IL-3 fused with truncated diphtheria toxin), with further progression on other cytotoxic and targeted therapies for BPDCN...Given the morphology, strong CD1A positivity, and lack of diffuse langerin positivity, indeterminate cell histiocytosis (indeterminate dendritic cell tumor) was favored. It is unclear whether this represents two morphologic manifestations derived from a single abnormal histiocytic precursor, or two distinct neoplastic processes, particularly given reports of low-grade B-cell lymphoma and leukemia in association with indeterminate cell histiocytosis and the distinct molecular findings.
  • ||||||||||  GSK3326595 / GSK, Elzonris (tagraxofusp) / Menarini
    [VIRTUAL] PRMT5 Inhibition Affects RNA Methylation and Is a Potential Therapeutic Target in BPDCN (Poster Hall (Virtual Meeting)) -  Nov 5, 2020 - Abstract #ASH2020ASH_2325;    
    Apart from the recently approved therapy, Tagraxofusp-erzs, treatment options for BPDCN remain limited...Functionally, in vitro growth of BPDCN cells treated with the PRMT5 inhibitor GSK3326595 (GSK595) was impaired in a dose-dependent manner, with net negative cell growth observed 6 days post-treatment...In addition, we show that elevated PRMT5 is important in BPDCN and its inhibition mitigates BPDCN progression. Therefore, PRMT5 inhibition is a potential therapeutic strategy for BPDCN.
  • ||||||||||  Elzonris (tagraxofusp) / Menarini
    [VIRTUAL] Survival Outcomes in Blastic Plasmacytoid Dendritic Cell Neoplasm By First-Line Treatment and Stem Cell Transplant (Poster Hall (Virtual Meeting)) -  Nov 5, 2020 - Abstract #ASH2020ASH_771;    
    In a multivariate Cox model (adjusting for age, front-line therapy, gender, and transplant) allo-SCT was significant factor for OS (HR=0.137, 95%CI=0.020-0.959, P=0.045). In conclusion, our study supports current recommendations of using SL-401 or hyper-CVAD as the first-line treatments followed by consolidation with allo-SCT in the eligible responders to induction therapy to further improve survival outcomes in BPDCN patients.
  • ||||||||||  Elzonris (tagraxofusp) / Menarini
    [VIRTUAL] Phase 2 Study of Tagraxofusp Therapy for BPDCN Patients Post-Autologous or Post-Allogeneic Hematopoietic Cell Transplantation (Poster Hall (Virtual Meeting)) -  Nov 5, 2020 - Abstract #ASH2020ASH_760;    
    P2
    Key exclusions: Persistent clinically significant non-hematologic toxicities ≥ grade 2; CNS involvement; receiving chemotherapy, radiotherapy, or other anti-cancer therapy within 14 days of first dose of study drug; uncontrolled infection; HIV/Hepatitis B and/or C; and clinically significant cardiopulmonary disease. Endpoints: Primary endpoints include safety and tolerability of tagraxofusp in patients with BPDCN post-HCT, with survival as secondary outcomes.
  • ||||||||||  Elzonris (tagraxofusp) / Menarini
    Biomarker, Review, Journal:  CD123 as a Biomarker in Hematolymphoid Malignancies: Principles of Detection and Targeted Therapies. (Pubmed Central) -  Nov 1, 2020   
    Multiple clinical trials are investigating the use of various CD123-targeting agents, including chimeric antigen receptor-modified T cells (expressing CD123, monoclonal antibodies, combined CD3-CD123 dual-affinity retargeting antibody therapy, recombinant fusion proteins, and CD123-engager T cells. In this review, we provide an overview of laboratory techniques used to evaluate and monitor CD123 expression, describe the strengths and limitations of detecting this biomarker in guiding therapy decisions, and provide an overview of the pharmacologic principles and strategies used in CD123-targeted therapies.
  • ||||||||||  Elzonris (tagraxofusp) / Menarini, Nippon Shinyaku
    Journal:  Role of Tagraxofusp in Treating Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN). (Pubmed Central) -  Oct 30, 2020   
    In phase I/II clinical trial, major responses were observed in 90% of treatment naïve patients, with 72% of the responses observed as complete remissions. Limitations on the usage of tagraxofusp, and strategies to handle those limitations were further explored in this review.
  • ||||||||||  Elzonris (tagraxofusp-erzs) / Menarini
    Trial completion date, Trial initiation date, Trial primary completion date:  Tagraxofusp in Patients With CD123+ or With BPDCN-IPh-like Acute Myeloid Leukemia (clinicaltrials.gov) -  Sep 17, 2020   
    P2,  N=50, Not yet recruiting, 
    Limitations on the usage of tagraxofusp, and strategies to handle those limitations were further explored in this review. Trial completion date: Nov 2024 --> Apr 2025 | Initiation date: Jul 2020 --> Dec 2020 | Trial primary completion date: Nov 2022 --> Apr 2023
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Elzonris (tagraxofusp) / Menarini
    Review, Journal:  Updates in Novel Therapies for Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN). (Pubmed Central) -  Aug 18, 2020   
    Tagraxofusp is the first CD123-targeted therapy approved as the first ever targeted treatment of BPDCN in patients aged 2 years and older...These include other CD123-targeted approaches, as well as active investigation in targets beyond CD123, such as the BCL-2 inhibitor, venetoclax...Newer targeted therapies have been recently introduced, with promising results and novel toxicities that are important to recognize and understand. Stem cell transplantation after achievement of complete remission remains the mainstay of therapy among younger/fit, eligible patients, regardless of treatment modality used.
  • ||||||||||  Elzonris (tagraxofusp) / Menarini, Nippon Shinyaku
    Review, Journal:  Blastic Plasmacytoid Dendritic Cell Neoplasm-Current Insights. (Pubmed Central) -  Aug 15, 2020   
    The United States Food and Drug Administration-approval of tagraxofusp (SL-401) in December 2018 has focused attention on this leukemia frequently associated with skin involvement. Herein, we aim to: (1) review etiology; (2) summarize diagnostic criteria; and (3) discuss historic treatments and novel therapies for BPDCN.