Breyanzi (lisocabtagene maraleucel) / BMS 
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 5 Diseases   11 Trials   11 Trials   982 News 


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  • ||||||||||  Characterization of Infectious Complications during the Expected Duration of Cytokine Release Syndrome (CRS) in Patients Receiving CAR T Cell Therapy  () -  Dec 11, 2023 - Abstract #TCTASTCTCIBMTR2024TCT_ASTCT_CIBMTR_905;    
    We retrospectively reviewed 191 patients treated with autologous CAR T cell products (idecabtagene vicleucel, ciltacabtagene autoleucel, tisagenlecleucel, axicabtagene ciloleucel, brexucabtagene autoleucel, lisocabtagene maraleucel) at Mount Sinai Hospital from April 2017 until February 2023...Levofloxacin as prophylaxis was given to 35% (60/170). These results suggest that judicious use of broad-spectrum antibiotics and limited infectious workup may be considered in clinically stable and non-neutropenic patients with CRS occurring during the pre-specified period post CAR T cell infusion.
  • ||||||||||  Breyanzi (lisocabtagene maraleucel) / BMS, Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
    T-Cell Large Granular Lymphocyte Population Involving Chimeric Antigen Receptor-Modified T (CAR T) Cells in Patients with Cytopenia after CD19-Targeted CAR T-Cell Therapy: Case Series () -  Dec 11, 2023 - Abstract #TCTASTCTCIBMTR2024TCT_ASTCT_CIBMTR_897;    
    A 52-year-old (y/o) female (F) with R/R primary mediastinal B-cell lymphoma with central nervous system (CNS) involvement was treated with out-of-specification tisagenlecleucel...A 62 y/o F with R/R diffuse LBCL (DLBCL), NOS and chronic hepatitis B was treated with axicabtagene ciloleucel...A 50 y/o F, with R/R DLBCL, NOS with CNS involvement and history of cold agglutinin disease was treated with lisocabtagene maraleucel...In two of the patients, a subset of the clonal population expressed the CAR transgene. This case series highlights T-LGL as a potential cause of PC after CAR-T therapy.
  • ||||||||||  Breyanzi (lisocabtagene maraleucel) / BMS, Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
    Review, Journal, CAR T-Cell Therapy:  Evolving Role of CAR T Cell Therapy in First- and Second-Line Treatment of Large B Cell Lymphoma. (Pubmed Central) -  Nov 13, 2023   
    ZUMA-12 demonstrated effectiveness for axi-cel as part of first-line treatment for high-risk LBCL. These results support a role for CAR T cell therapy as new second-line SOC for r/r LBCL and highlight its potential evolution into future first-line treatment for high-risk disease.
  • ||||||||||  Breyanzi (lisocabtagene maraleucel) / BMS, Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
    Patterns and Safety of Glucocorticosteroids Use Following CD19 CAR-T Cell Therapy for B-Cell Lymphoma (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_6347;    
    Steroids were expressed as dexamethasone equivalent...Results : 292 patients with R/R B-NHL received commercial CAR-T cell therapy (48% axi-cel, 24% tisa-cel, 22% liso-cel, and 6% Brexu-cel), primarily for large B cell cell lymphoma (85%), mantle cell (11%) or follicular (4%) lymphoma...The discrepancy is likely due to our study's exclusion of steroid use prior to CAR-T and statistical analysis. Overall, our findings suggest that steroid administration for CAR-T cell therapy toxicity management is safe and does not appear to have a negative impact on efficacy.
  • ||||||||||  Breyanzi (lisocabtagene maraleucel) / BMS, Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
    Real-World Outcomes in Patients with Transformed Follicular Lymphoma Treated with CD19-Targeting CAR-T Therapy (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_6346;    
    CD19-targeting CAR-T cell therapy is effective for pts with relapsed/refractory tFL, including patients with characteristics of poor prognosis, with efficacy and toxicity profiles comparable to that observed in previous DLBCL studies. Unfortunately, pts who relapse post-CAR-T therapy have limited effective therapeutic options available, and this currently remains an unmet medical need within the field.
  • ||||||||||  Breyanzi (lisocabtagene maraleucel) / BMS, Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
    Higher CD4+ T Cell Counts after CAR-T in Large B-Cell Lymphomas Are Significantly Associated with Better Overall Survival (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_6268;    
    Methods Adult patients with primary or transformed LBCL treated with CD19-CAR-T cells, namely axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), and lisocabtagene maraleucel (liso-cel), between 2017 and 2022 were included in this single center retrospective study...Lymphodepletion was mostly cyclophosphamide and fludarabine (82.4%)...Additionally, we identified several factors that impact IR, which in turn shapes OS. In doing so, we show that CD4+ T lymphocytes are key players in disease response post-CAR-T and suggest that tracking CD4+ recovery following CAR-T may provide both diagnostic and therapeutic benefit.
  • ||||||||||  CNS Radiotherapy As Bridging Prior to CAR T-Cell Therapy for Non-Hodgkin B-Cell Lymphoma (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_5934;    
    While overall numbers are limited to date, the rate of severe CRS and ICANS is similar to that of historical series of CNSL patients treated with CAR T. However, a larger cohort will be required to determine the safety of CNS-BRT. These data support further study of RT, and exploration of involved site brain RT, as an effective bridging modality for CAR T-cell therapy in CNSL.
  • ||||||||||  Manufacturing of a Subsequent Autologous CAR-T Product after Prior CAR-T Is Safe and Feasible (SDCC - Room 6DE) -  Nov 3, 2023 - Abstract #ASH2023ASH_5223;    
    P1
    One of the two patients received prior alemtuzumab in combination with a CAR19 product, likely contributing to the failure. Among the 38 who were successfully manufactured, 37 patients had received prior CAR19, including axi-cel (n = 28), tisa-cel (n = 3), liso-cel (n = 3), autologous CAR19 in clinical trial (n = 1), bispecific CD19/CD22 CAR-T (n = 1), and bispecific CD19/CD20 CAR-T (n = 1).
  • ||||||||||  Incidence and Outcomes of Cytomegalovirus Reactivation after Chimeric Antigen Receptor T Cell Therapy (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_4462;    
    CMV reactivation is a common complication of CAR T cell therapy in CMV seropositive individuals. Although confirmatory studies are needed, our data shows that administration of immunosuppression, in particular steroids, for management of CAR T cell toxicities is a major risk factor for CMV reactivation, and close monitoring for preemptive therapy or antiviral prophylaxis might be indicated in this setting.
  • ||||||||||  Real-World Outcomes of CD19CAR T Cell Therapy in Adult Patients with Relapsed Refractory Transformed Indolent Lymphoma (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_4457;    
    In TIL and dDLBCL cohorts, 76%/73% received axicabtagene ciloleucel, 17%/18% tisagenlecleucel, and 7%/10% lisocabtagene maraleucel, respectively...In TIL and dDLBCL cohorts, respectively, 49%/59% of pts received tocilizumab for CRS and 41%/51% received steroids for CRS or ICANS...The results indicate that CD19CAR T is tolerable and active in pts with r/r TIL with safety and efficacy outcomes similar to that observed in pts with dDLBCL. Our findings suggest CD19CAR T cell therapy may be able to overcome the historically poor prognosis associated with r/r TIL.
  • ||||||||||  Copiktra (duvelisib) / Secura Bio, Yakult Honsha
    Duvelisib for Cytokine Release Syndrome Prophylaxis during CD19-Targeted CAR T Cell Therapy (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_4415;    
    P1
    Preliminary data from this study suggest that the addition of duvelisib to CAR T-cell therapy may prevent grade 3-4 CRS and also delay the onset of CRS. Although limited follow-up is available, the depth and duration of response is similar to published data for CAR T-cells in this setting.
  • ||||||||||  Breyanzi (lisocabtagene maraleucel) / BMS
    Evaluation of the T-Cell Metabolic State of Starting Material and Manufactured CAR T Cell Products and Clinical Outcome of CAR T-Cell Therapy for Large B Cell Lymphoma (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_4400;    
    P1
    Methods Samples were obtained from large B cell lymphoma (LBCL) patients that were part of the TRANSCEND-NHL-001 trial (NCT02631044, Abramson et al, Lancet 2020).Thirty-two patients with r/r B-cell lymphoma who received CAR-T cell treatment lisocabtagene maraleucel (16 responders (R) and 16 non-responders (NR)) were included in our analyses and (metabolically) analyzed by flow cytometry and extracellular flux analysis...More specifically, a higher abundance of memory phenotypes, metabolic activity and mitochondrial biogenesis of both harvested T cells and CAR-T product associates with improved clinical response. Combining metabolic, phenotypical and clinical characteristics and biomarkers of patient T cells (both pre- or post-production) shows the importance of the metabolic phenotype and fitness of T cell starting material, underlying the importance of early line CAR T therapy following diagnosis.
  • ||||||||||  Outcomes of Patients with Primary Mediastinal B-Cell Lymphoma Refractory or Relapsed after Frontline R-EPOCH Chemotherapy (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_4041;    
    25% (13/51) received Brentuximab (BV) + Nivolumab (Nivo) salvage therapy as either 1 st line ST (N=7) or 2 nd line ST (N=6) with ORR(CR) rate of 84%(46%) and a 2 yr PFS of 75% (95% CI 53, 100)...Thirty-four percent (19/56) of pts received CAR T (axi-cel 84%, CAR T on clinical trial 11%, liso-cel 5%), with 1 pt receiving as 1 st line ST and all other receiving as > 2 nd line ST...Only 24% of refractory pts had CR to initial salvage. CAR T and allo showed promise as options in pts with multiply relapsed disease.
  • ||||||||||  Breyanzi (lisocabtagene maraleucel) / BMS, Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
    Chimeric Antigen Receptor T-Cell (CAR-T) Therapy in Secondary Central Nervous System Large B-Cell Lymphoma (SCNSL): A Multicenter Retrospective Analysis (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_4018;    
    Fludarabine/cyclophosphamide was used as lymphodepletion in 84 patients (93%)...Conclusion In this largest known case series to date, CAR-T therapy appeared safe and feasible in patients with SCNSL, but is associated with high rates of treatment failure, particularly in patients with active CNS disease at CAR-T infusion. This warrants further study of optimal CNS-directed treatment strategies prior to CAR-T, development of novel cellular therapy platforms or consideration of post CAR-T maintenance therapy in these high-risk patients.
  • ||||||||||  Breyanzi (lisocabtagene maraleucel) / BMS
    Lisocabtagene Maraleucel in Relapsed/Refractory Large B-Cell Lymphoma: Real World Analysis from the Cell Therapy Consortium (SDCC - Ballroom 20AB) -  Nov 3, 2023 - Abstract #ASH2023ASH_3299;    
    P=N/A
    Bridging therapy was used in 62% of pts including 41% receiving polatuzumab-based treatment, 24% chemoimmunotherapy, and 21% radiation therapy...Tocilizumab was administered in 31% and 31% of pts received steroids for toxicity management...These results also likely reflect advancements in patient selection and toxicity management including the real world utilization of novel bridging therapy to temporize and debulk disease. Follow-up is ongoing and updated data will be presented at the meeting.
  • ||||||||||  Breyanzi (lisocabtagene maraleucel) / BMS, Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
    Chimeric Antigen Receptor (CAR (SDCC - Ballroom 20AB) -  Nov 3, 2023 - Abstract #ASH2023ASH_3297;    
    The high NRM rate of 9% at two years highlights the importance of continued follow-up in this at-risk population. The CIBMTR is supported primarily by the Public Health Service U24CA076518 from the National Cancer Institute (NCI), the National Heart, Lung, and Blood Institute (NHLBI) and the National Institute of Allergy and Infectious Diseases (NIAID); 75R60222C00011 from the Health Resources and Services Administration (HRSA); N00014-21-1-2954 and N00014-23-1-2057 from the Office of Naval Research.
  • ||||||||||  Machine Learning-Based Time-Series Clustering Identifies Archetypal Trajectories of Hematotoxicity after CAR T-Cell Therapy (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_2579;    
    CAR T-cell products were axi-cel, n= 101 (25%); brexu-cel, n = 24 (6%); cilta-cel, n = 21 (5%); liso-cel, n = 46 (11%); ide-cel, n = 25 (6%); tisa-cel, 12 (3%); and investigational CD19 or CD20 CAR T-cell products, n = 174 (43%). A logistic regression model using pre-LD ANC, platelet, Hb, LDH, CRP, and ferritin showed improved discrimination and sensitivity compared to CAR-HEMATOTOX in our training set, but both models had low specificity (poor ability to
  • ||||||||||  Breyanzi (lisocabtagene maraleucel) / BMS, Yescarta (axicabtagene ciloleucel) / Gilead
    Lisocabtagene Maraleucel Versus Axicabtagene Ciloleucel: Efficacy and Toxicity in a Real-World Setting (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_2567;    
    In multivariable analyses, pre-LD LDH and largest lesion diameter were the only factors independently associated with response outcomes. We conclude that liso-cel is a robust alternative to other CD19 CAR-T products in older and frailer LBCL pts.
  • ||||||||||  Breyanzi (lisocabtagene maraleucel) / BMS, Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
    18F-FDG PET/CT Imaging Biomarkers for CAR-T Cell Therapy Outcomes in Large-B-Cell Lymphoma (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_2056;    
    Our findings indicate that standard PET features (MTV and SUVmax) predict both toxicity and efficacy of CAR-T cell therapy, while also showing correlations with systemic inflammation. Additionally, we present, for the first time, the relevance of granular radiomic features in assessing the probability of treatment success.
  • ||||||||||  Breyanzi (lisocabtagene maraleucel) / BMS
    Lisocabtagene Maraleucel (liso-cel) in R/R CLL/SLL: 24-Month Median Follow-up of TRANSCEND CLL 004 (Grand Hyatt - Grand Hall D) -  Nov 3, 2023 - Abstract #ASH2023ASH_1381;    
    P1/2
    With longer follow-up, liso-cel continued to demonstrate durable CR/CRi, high uMRD rates, and a manageable safety profile in patients with heavily pretreated, high-risk R/R CLL/SLL. The safety results from longer follow-up were similar to those reported in the primary analysis with no new safety signals and were consistent across age groups.