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  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
    CNS Involvement in Adult Patients with B-Cell Acute Lymphoblastic Leukemia (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_2597;    
    One hundred and four patients (22%) received mini-hyper-CVD (PMID 37187201), with or without inotuzumab ozogamicin, blinatumomab, or anti-CD20 monoclonal antibody...Conclusions We found that MRD- response was associated with a decreased risk of CNS relapse, and increased peripheral blasts were associated with increased risk of CNS involvement at diagnosis and subsequent relapse. Further research is needed to characterize risk factors for CNS involvement in adults with ALL to better influence therapeutic strategies.
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
    Clinical and Molecular Characterization of TP53-Mutant Acute Lymphoblastic Leukemia (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_2575;    
    Loss of heterozygosity, characterized by TP53 AF >0.5 is associated with even worse survival. New therapies are urgently needed to improve outcomes in this subset.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Qol-Blina Protocol: Preliminary Data of a Paediatric Italian Multicentric Study (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_2573;    
    Previous researches have demonstrated the efficacy of blinatumomab, but no specific studies have been performed on Quality of Life (QoL) in pediatric patients during this treatment...Further patients are needed to confirm the data. According to these data we suggest to focusing on the individual and family psychosocial aspects, using personalized clinical interventions to provide adequate coping strategies and support the critical psychological issues related to disease.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
    Impact of TP53 Mutation on Survival Outcomes in Acute Lymphoblastic Leukemia at a Tertiary Center (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_2560;    
    Although muTP53 ALL achieved a higher MRD-FC negative response compared to wtTP53 ALL, this did not translate into long-term survival in the muTP53 ALL. Whether using NGS for B-cell and T-cell receptors as a method for MRD testing, like clonoSEQ
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Measurable Residual Disease in Adult B Lymphoblastic Leukemia: A Study of Concordance between Multiparametric Flow Cytometry, Next-Generation Sequencing of Immunoglobulin Gene Rearrangements, and Quantitative PCR (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_2530;    
    Method : This study involved adult patients aged 19 or older with B-ALL, treated with modified hyper-CVAD (hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone) and allogeneic hematopoietic stem cell transplant (allogeneic-HSCT) at Catholic Hematology Hospital from May 2022 to June 2024...Poor MRD response was defined as > 0.1%, and complete MRD response as < 0.001%, and poor MRD responders were treated with MRD-directed therapy using blinatumomab or next-generation tyrosine kinase inhibitors...Conclusion : Our data suggested all MRD detection methods showed acceptable power and good concordance rates, but the detection power was different between Ph-positive and Ph-negative ALL. We also suggested MRD-directed therapeutic strategies might predict the significant time point of MRD for the prediction of survival outcomes.
  • ||||||||||  navtemadlin (KRT-232) / Kartos Therap
    Results from the Randomized, Multicenter, Global Phase 3 BOREAS Study: Navtemadlin Versus Best Available Therapy in JAK Inhibitor Relapsed/Refractory Myelofibrosis (Harbor Ballroom DEFG (Manchester Grand Hyatt San Diego)) -  Nov 6, 2024 - Abstract #ASH2024ASH_2278;    
    P2/3, P3
    Pts were randomized 2 : 1 to receive navtemadlin monotherapy 240 mg once-daily (Day 1-7/28-day cycle) or BAT (monotherapy or combinations : hydroxyurea, chemotherapy, IMiDs, and supportive care; JAKi were excluded)...Baseline characteristics were well balanced between the arms and included : int-1/int-2/high-risk MF per DIPSS (34%/50%/15%), median spleen volume of 2310 cm3, median TSS of 20.8, prior therapy range of 1-6 (99% had ruxolitinib [rux]), median time from initial MF diagnosis was 47.6 months, 34% of pts had platelets <100x109/L, 48% had a bone marrow fibrosis of grade 3, 70% had the JAK2V617F driver mutation, and 77% had ?1 high molecular risk mutation (?2 in 23%)...The rate of SVR35 and TSS50 at Week 24 was three-fold and two-fold higher with navtemadlin vs BAT, validating the novel approach of MDM2 inhibition in pts with MF. Further studies of navtemadlin in MF are warranted, including as add-on therapy to rux treatment in JAKi-naive pts who have a suboptimal response to rux (POIESIS; NCT06479135).
  • ||||||||||  Nplate (romiplostim) / Amgen, Promacta (eltrombopag) / Novartis
    Development of a First-in-Class CAR-T Therapy Against Calreticulin-Mutant Neoplasms and Evaluation in the Relevant Human Tissue Environment (Seaport Ballroom EFGH (Manchester Grand Hyatt San Diego)) -  Nov 6, 2024 - Abstract #ASH2024ASH_2247;    
    Conclusions : Here we present a novel CAR-T therapy showing potent and remarkably selective targeting of mutCALR-driven malignancies. This study also evaluates the impact of JAKi on CAR-T efficacy and presents the first use of human organoids to evaluate immunotherapies in the relevant human tissue environment, including features of the TME, validating this as a powerful platform for pre-clinical development of targeted therapies across blood cancers.
  • ||||||||||  Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
    Combining ESA and Luspatercept in Non-RS MDS Patients Having Failed ESA - Results of the Phase 1-2 Part a of the GFM Combola Study (Ballroom 20AB (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_2200;    
    Based on a TITE-BOIN-ET design, Epoetin alfa was administered weekly at dose concentrations ranging from 30 000UI to 60 000 UI...All patients had resistance to ESA and 7 had also received Revlimid (n=3), IDH inhibitors (n=2), Thalidomide (n=1), AZA (n=1)...Based on the results of this Phase 1 study, the dosing schedule Luspatercept 1.75 mg/kg/21d and EPO 60 000 UI/w, that balanced clinical efficacy and safety profile was selected as the RP2D. This regimen is being compared to Luspatercept 1.75 mg/kg/21d in the ongoing randomized Phase 2 study.
  • ||||||||||  Carvykti (ciltacabtagene autoleucel) / J&J
    Early Safety and Efficacy of CAR-T Cell Therapy in Precursor Myeloma: Results of the CAR-PRISM Study Using Ciltacabtagene Autoleucel in High-Risk Smoldering Myeloma (Pacific Ballroom Salons 24-26 (Marriott Marquis San Diego Marina)) -  Nov 6, 2024 - Abstract #ASH2024ASH_2114;    
    Patients receive lymphodepletion (LD) with fludarabine and cyclophosphamide followed by cilta-cel infusion...Tocilizumab was administered to 4 patients and 2 patients received dexamethasone...One patient experienced grade 4 immune related thrombocytopenia secondary to fludarabine, which resolved within 2 weeks after treatment with dexamethasone, IVIG and romiplostim...All patients achieved MRD negative (10-6 ) disease and long-term follow up is required to determine whether these responses will be sustained. The benefit of no induction therapy and potential long-term remissions may be disruptive for future therapeutic algorithms in MM.
  • ||||||||||  Ibrance (palbociclib) / Pfizer, Imbruvica (ibrutinib) / AbbVie, J&J
    Disrupting IL10 Signaling Overcomes Compound Copy Number Variation-Driven Clinical Resistance to CDK4/6 and BTK Inhibition in Mantle Cell Lymphoma (Ballroom 20CD (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_2039;    
    In summary, by integrated longitudinal scRNA-seq analysis of a hypothesis-driven clinical trial, we have provided the first evidence in humans that 1) CDK4/6 inhibition deepens and prolongs the clinical response to BTKi; 2) cCNV of CDK4-RB1-CDKN2A drives differential expansion of resistant C2 MCL cells in transit to proliferating C4 MCL cells or long-lived non-proliferating C3 MCL cells; 3) CD8+ T cell maintenance and surveillance cooperates with MCL cell intrinsic cCNV to discriminate durable response from resistance; and 4) IL10 is a key mediator of MCL-Immune cell interaction that promotes resistance. These discoveries have profound implications for genome-guided strategy to overcome drug resistance in MCL.
  • ||||||||||  Mapping the Drug Combination Landscape for AML: An Integrative Ex Vivo Functional and Computational Approach (Room 6DE (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_1771;    
    Clinical outcomes and ex vivo Venetoclax+Azacitidine (VenAza) DSS were derived from 12 patients treated with VenAza (Chow et al...Notably, 68 combinations surpassed VenAza in both efficacy and CI, including approved drug partners like Ven (n=12), Trametinib (n=11) and Idelalisib (n=11)...These clusters showed differential response towards 77 combinations, with biases in primitive clusters for Ven + Aza/Ibrutinib and mature clusters for Ven + Palbociclib/Quizartinib...By integrating multiomics data and rigorously testing over 100 different variables, our findings reinforced cell maturation states as determinants of combination drug responses. A novel finding reveals maturation status is accompanied by activation of inflammatory states in AML, indicating a role of differentiation block in shaping immune response.
  • ||||||||||  Nplate (romiplostim) / Amgen
    Critical Bleeding in Adults and Children with Immune Thrombocytopenia: A Multicentre Cohort Study (Room 30 (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_1743;    
    Common interventions included corticosteroids, IVIG and platelet transfusion; however, time to first treatment was approximately 5 hours, and longer for adults than children. A standardized approach to the management of ITP critical bleeds is needed.
  • ||||||||||  CSF1R Targeting T Cell Engaging Bispecific Antibodies Enable Safe and Efficient Immunotherapies in Acute Myeloid Leukemia (Marriott Grand Ballroom 8-9 (Marriott Marquis San Diego Marina)) -  Nov 6, 2024 - Abstract #ASH2024ASH_1636;    
    While the use of T cell engaging bispecific antibodies (TCE) targeting B cell lineage antigens such as CD19 (Blinatumomab) or CD20 (Epcoritamab, Glofitamab, Mosuenetuzumab) have induced strong and long-lasting response rates in B cell malignancies (Falchi, Vardhana et al...Early clinical trials of CD33-TCE (JNJ-67571244, AMG330) or CD123-TCE (Vibecotamab) have shown modest clinical activity (response rates ranging between 0 to 16,6%) and a high degree of treatment-emergent adverse events (TEAE) (Ravandi, Bashey et al...In summary, we could show the safety and efficacy of CSF1R-TCB in preclinical in vitro and in vivo models and demonstrate the superior safety profile of CSF1R-TCB compared to CD33-TCB in CB-humanized mouse models. In cell line-derived xenograft models of AML, CSF1R-TCB induced anti-leukemia activity, warranting further preclinical and clinical investigations.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Affinity-Tuned T-Cell Engager for Dual Targeting of B-Myeloid Mixed-Phenotype Acute Leukemia (B-MPAL) (Ballroom 20AB (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_1629;    
    Blinatumomab, a bispecific antibody recognizing only CD19, has been a successful addition to treating both childhood and adult ALL...Taking advantage of the unique features of MPAL we developed a novel immunotherapy with improved half-life, potency, selectivity, and safety. This work serves as a proof of concept that the combinatorial use of binders with the proper affinity for their respective targets allow for the generation of highly specific immunotherapies with minimal cytotoxicity for normal cells.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen, Actemra IV (tocilizumab) / Roche, JW Pharma
    CD19-CAR T Cells As Definitive Consolidation for Older Adults with B-Cell Acute Lymphoblastic Leukemia in First Complete Remission: A Pilot Study (Marriott Grand Ballroom 5-6 (Marriott Marquis San Diego Marina)) -  Nov 6, 2024 - Abstract #ASH2024ASH_1319;    
    P1
    Ten (77%) pts received blinatumomab as part of initial therapy...Among pts who completed the DLT period (n=11), 7 (64%) experienced transient grade (G) 1 cytokine release syndrome (CRS) that resolved with tocilizumab +/- corticosteroid...CAR T cells had a robust expansion in the blood and CSF despite the low antigen setting. We have observed preliminary durable remissions and pts maintained function and cognition on day 100 post CAR-T.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Efficacy and Safety of Adding Blinatumomab to First-Line Treatment for Chinese Children with B-Cell Acute Lymphoblastic Leukemia (Marriott Grand Ballroom 5-6 (Marriott Marquis San Diego Marina)) -  Nov 6, 2024 - Abstract #ASH2024ASH_1307;    
    Adverse events associated with blinatumomab were tolerable, with treatment discontinuation in 6 (6.7%) patients, including G3 infection-related events in 3 (3.3%) patients and G3/4 immune effector cell-associated neurotoxicity syndrome (ICANS)-related epilepsy in 3 (3.3%) patients. Conclusion : In children with chemotherapy-intolerant or intermediate-risk/high-risk B-ALL, the addition of blinatumomab to first-line chemotherapy can enhance the deep remission rates and improve survival, particularly in high-risk patients and those with high MRD after induction regimen.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    TCL1A Is Associated with Blinatumomab Response and Immune Activation in Pediatric B-ALL (Marriott Grand Ballroom 5-6 (Marriott Marquis San Diego Marina)) -  Nov 6, 2024 - Abstract #ASH2024ASH_1292;    
    As blina is being integrated into frontline treatment, it is paramount that we understand the factors that influence response and resistance. Ultimately, these data will help guide risk allocation and treatment interventions to improve responses to blina with the overall goal of reducing toxicities and improving survival for patients with B-ALL.
  • ||||||||||  Prolia (denosumab) / Amgen
    Retrospective data, Journal:  High-dose denosumab (Xgeva (Pubmed Central) -  Nov 5, 2024   
    Not yet recruiting --> Recruiting This study confirmed a significant MRONJ incidence of 2.66% among high-dose denosumab recipients, highlighting the importance of careful patient selection, monitoring, and education, particularly in older and long-term treatment patients, to mitigate the risk of MRONJ.