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


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  • ||||||||||  Estimating the Impact on Survival of Not Receiving CAR T Therapy Despite Being Eligible in Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) Patients in Germany (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_4547;    
    In this updated guideline, second line (2L) R/R DLBCL pts are stratified based on their CAR T eligibility and axicabtagene ciloleucel (axi-cel) or lisocabtagene maraleucel (liso-cel) are recommended for pts with refractory disease and early relapse...In addition, bispecific antibodies (BsAb) glofitamab and epcoritamab have been approved and are also recommended for use in the 3L+ setting...We acknowledge that clinical practice is variable, and guidelines may not be appropriate for all pts. Nonetheless, greater efforts are needed to ensure that CAR T eligible pts are identified systematically, and referral pathways are optimized to ensure all eligible pts receive CAR T therapy.
  • ||||||||||  Global Access to Chimeric Antigen Receptor (CAR) T-Cell Therapies: Health Technology Assessment (HTA) of CAR T in G7 Countries and Australia (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_4524;    
    Among the CAR-Ts, HICs most frequently provided reimbursement for axi-cel for DLBCL (the only indication with demonstrated overall survival benefit) and least often provided reimbursement for ide-cel and cilta-cel for myeloma (for which CAR-T cells do not yet appear to have curative potential, though this may be one of multiple reasons). Our results demonstrate that HTA decisions are not necessarily the bottleneck in the HICs for access to CAR-T among patients for which the data indicate the greatest therapeutic potential, and that approaches are heterogeneous between jurisdictions.
  • ||||||||||  Breyanzi (lisocabtagene maraleucel) / BMS, Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
    Pre-CAR-T GTE Scoring of Electroencephalogram Abnormalities As Predictive Biomarkers for Icans (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_3804;    
    The novel application of the GTE scoring system provides a new avenue for risk stratification and highlights the importance of EEG abnormalities as predictive biomarkers for ICANS. This knowledge can help identify high-risk patients and improve management strategies, ultimately enhancing patient outcomes in CAR-T cell therapy.
  • ||||||||||  Breyanzi (lisocabtagene maraleucel) / BMS, Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
    Myeloid Neoplasia after CD19 Directed CAR-T Cells : Cumulative Incidence, Risk Factors and Outcome (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_3802;    
    These tMNs exhibited a poor prognosis with more frequent adverse molecular and cytogenetic profiles compared to other tMN previously reported (Belhabri, 2023). To further explore the prognosis of tMNs after CAR-T cell therapy, comparisons with a control group is ongoing and will be presented at ASH.
  • ||||||||||  Multiplexed Cytokine Assessment of T- and NK-Cell Responses to Tumor Cells: Parallel Assessment of Biomarkers Associated with Efficacy, Safety, and Persistence (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_3746;    
    Additional confirmatory studies with NKTR-255 as adjuvant treatment to CAR-T therapy and other cellular therapies are warranted. Multiple CAR T therapies (eg Kymriah, Yescarta, and Breyanzi) have been approved by the FDA since 2017...Secreted biomarkers associated with efficacy and persistence (e.g. IFN?, Granzyme B, IL7, IL15) were also detected in co-cultures of HEK293 with TALL104 further indicating that the TALL104 cell is facilitating a cytolytic mechanism and persisting due to T cell receptor / HLA engagement with target HEK293 cells...Here, we have demonstrated the utility of Meso Scale
  • ||||||||||  Patterns of Immune Reconstitution and Their Clinical Significance in Aggressive Lymphoma Treated with CAR-T Therapy (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_3631;    
    Cyclophosphamide and fludarabine lymphodepletion was used in 86.7% of patients...Notably, neither CD4+ nor CD8+ T cell recovery was influenced by lymphodepletion regimen or exposure to tocilizumab or corticosteroids...Among immune subsets considered, NK cell recovery emerges as a robust predictor of favorable clinical outcomes. In summary, this novel biomarker may serve as an important prognostic marker of disease outcome following CAR-T and also provide insights into the biology of post-CAR-T relapse.
  • ||||||||||  Breyanzi (lisocabtagene maraleucel) / BMS, Yescarta (axicabtagene ciloleucel) / Gilead
    Real World Comparison of Axicabtagene Ciloleucel and Lisocabtagene Maraleucel in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_3182;    
    Although comparisons for OS cannot be made due to published trial's data maturity, this study provides real-world evidence for pts with RR DLBCL who underwent treatment with either axicel or lisocel. Further maturation of data from clinical trials is needed to better guide treatment for these groups, but comparison data from our analysis looks promising and doesn't show any significant difference between the two products.
  • ||||||||||  Breyanzi (lisocabtagene maraleucel) / BMS, Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
    CAR T-Cell Therapy for DLBCL with CNS Involvement: Overall Safe and Effective with Limited Efficacy in Patients with Leptomeningeal Disease (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_3036;    
    Pts received CAR-T cell therapy with axicabtagene ciloleucel (31%), tisagenlecleucel (29%), lisocabtagene maraleucel (24%), or point-of-care anti-CD19 therapy (16%) (Kedmi et al, Tansplant Cell Ther 2022)...Conclusions : In pts with S/PCNSL treated with CAR-T cell, we observed a safety and efficacy profile of CAR-T cell therapy comparable to that seen in recent CNSL series. Furthermore, we confirmed inferior PFS and OS in pts with isolated LEPT disease compared to those with PARE disease, suggesting the need for novel therapeutic to better control LEPT disease pre-CAR-T cell or consolidation approaches tailored specifically for pts with LEPT involvement.
  • ||||||||||  Impact of Pre-Existing Mental Health Disorders (MHD) on CAR T-Cell Therapy Outcomes in Patients with Large B-Cell Lymphoma (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_3035;    
    380 (86%) received axicabtagene ciloleucel, 42 (10%) received lisocabtagene maraleucel, 19 (4%) received tisagenlecleucel...Patients with MHD had a higher incidence of grade ?3 CRS (19% vs. 9.4%, p=0.0040) and grade ?3 ICANS (51% vs. 26%, p<0.0001), as well as higher use of anakinra (14% vs. 5%, p=0.0019) and corticosteroids (65% vs. 46%, p=0.0001) for CAR-T related toxicity...This data supports access to CAR-T for patients with MHD and underscore the need for integrated psychiatric care and close monitoring to reduce adverse events. Future research should assess if targeted interventions can mitigate CAR-T related toxicity in patients with MHD.
  • ||||||||||  Breyanzi (lisocabtagene maraleucel) / BMS, Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
    Impact of Pre-Treatment Liver-Related Factors on Clinical Outcomes after CAR T-Cell Therapy for Lymphoma (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_3033;    
    However, the presence of either lymphomatous lesions or ascites on baseline imaging prior to CAR-T were both poor prognostic factors for disease progression and for overall survival. Further studies are needed to elucidate the underlying mechanisms for these findings which have implications for counselling prior to CAR-T and monitoring after therapy.
  • ||||||||||  Breyanzi (lisocabtagene maraleucel) / BMS, Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
    CD19 CAR-T Cell Therapy Is Effective in Richter Transformation: A Multicenter Retrospective Analysis By the European Research Initiative on Chronic Lymphocytic Leukemia (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_3031;    
    Results : The study included 54 patients with RT treated with anti-CD19 CAR-T cells (investigational products : n=29, 54%; tisagenlecleucel : n=20, 37%; axicabtagene ciloleucel : n=4, 7%; lisocabtagene maraleucel : n=1, 2%)...Lymphodepletion consisted of fludarabine with cyclophosphamide in 46/52(85%) and bendamustine in 8 (15%) patients...Conclusions : The current study demonstrates clinically significant response rates and manageable toxicity in patients with RT treated with investigational as well as commercially available CAR-T cell products. These findings could potentially pave the way for new treatment paradigms in the management of this high-risk and challenging patient population.
  • ||||||||||  Breyanzi (lisocabtagene maraleucel) / BMS, Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
    CAR T Cell Therapy in Early Relapsed/Refractory Large B-Cell Lymphoma: Real World Analysis from the Cell Therapy Consortium (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_3030;    
    Among 53 (34%) pts receiving CAR T in 2L, 74% received axi-cel and 26% liso-cel, and among 102 (66%) pts receiving CAR T in 3L+, 48% received axi-cel, 24% tisa-cel and 28% liso-cel...Fludarabine/cyclophosphamide LDc was received by 76% of pts and bendamustine by 23%...While our analysis is limited by short follow-up and limited subgroup cohort size, our data suggest similar outcomes for early R/R LBCL pts treated with CAR T in 2L vs 3L+. Selection of more fit pts and efforts to reduce disease burden prior to infusion may improve survival outcomes for early R/R LBCL pts treated with CAR T regardless of line of therapy.
  • ||||||||||  A Proof-of-Principle of Split-Course Bridging Radiotherapy (SC-BRT) Prior to CAR T-Cell Therapies for Relapsed or Refractory B-Cell Lymphomas: A Phase 1a Pilot Cohort (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_3024;    
    P1
    The feasibility outcome was achieved, as all pts successfully received SC-BRT and standard cyclophosphamide/fludarabine LD followed by commercial lisocabtagene maraleucel (n=4) or axicabtagene ciloleucel (n=2)...One patient was treated with steroids and tocilizumab for mild CRS and the patient with grade 5 CRS received steroids, tocilizumab and siltuximab but expired on day +6...This is the first reported delivery of any form of RT following administration of LD chemotherapy potentially opening the door for novel CART conditioning approaches. Given successful completion of Phase 1a, 14 additional patients are now being recruited to the Phase 1b expansion cohort (9 already accrued, data not presented) to confirm safety, assess preliminary outcomes and explore possible immune augmentation.
  • ||||||||||  Breyanzi (lisocabtagene maraleucel) / BMS, Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
    Impact of Broad-Spectrum Antibiotic Exposure on CAR-T Therapy Outcomes in B-Cell Lymphoma: A Multicenter International Study (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_3014;    
    Background : Previous studies by us and others have shown that broad-spectrum antibiotic exposure, particularly with PIM (piperacillin-tazobactam, imipenem, and meropenem), before CD19-chimeric antigen receptor T-cell (CAR-T) therapy is associated with poor outcomes in B-cell malignancies...This study aims to elucidate the influence of commonly used broad-spectrum antibiotics, including 4th generation cephalosporins (CS, e.g., Cefepime) and PIM, on the efficacy of CAR-T therapy...Axi-cel was the most common CAR-T product (40%), followed by tisa-cel (35%), liso-cel (12%), and a CD19-point-of-care academic product (13%)...Importantly, initiation of broad-spectrum antibiotics after CAR-T infusion with an exposure of less than 10 days did not appear to compromise anti-lymphoma treatment efficacy. These findings may help guide antibiotic use in patients undergoing CAR-T therapy.
  • ||||||||||  Treatment Patterns and Outcomes Following Progression of Disease Post-CAR-T Therapy in Relapsed or Refractory Mantle Cell Lymphoma: A Multicenter Analysis (Marriott Grand Ballroom 11-13 (Marriott Marquis San Diego Marina)) -  Nov 6, 2024 - Abstract #ASH2024ASH_1998;    
    Pts received brexucabtagene autoleucel (88%) or lisocabtagene maraleucel (12%)...The most commonly used first-line systemic Tx post-CAR-T progression included : pirtobrutinib in 13 pts [overall response rate (ORR) 31%], chemoimmunotherapy in 12 pts (ORR 25%), venetoclax in 10 patients (ORR 20%), bispecific antibodies (BsAb) in 10 pts (ORR 60%), and small molecule combinations (at least 2 of BTK inhibitor, BCL2 inhibitor, and lenalidomide) in 8 patients with ORR 50%...The presence of a TP53 mutation significantly predicted inferior OS, corroborating the prognostic importance of this finding in the post-CAR-T context. Data from pts treated at additional sites and updated analyses will be presented at the meeting.
  • ||||||||||  Estimating the Impact on Survival of Not Receiving CAR T Therapy Despite Being Eligible in Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) Patients in Germany (Halls G-H - Blood Journals Studio (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_1207;    
    In this updated guideline, second line (2L) R/R DLBCL pts are stratified based on their CAR T eligibility and axicabtagene ciloleucel (axi-cel) or lisocabtagene maraleucel (liso-cel) are recommended for pts with refractory disease and early relapse...In addition, bispecific antibodies (BsAb) glofitamab and epcoritamab have been approved and are also recommended for use in the 3L+ setting...We acknowledge that clinical practice is variable, and guidelines may not be appropriate for all pts. Nonetheless, greater efforts are needed to ensure that CAR T eligible pts are identified systematically, and referral pathways are optimized to ensure all eligible pts receive CAR T therapy.
  • ||||||||||  Breyanzi (lisocabtagene maraleucel) / BMS, Tecartus (brexucabtagene autoleucel) / Gilead, Carvykti (ciltacabtagene autoleucel) / J&J
    The Cost of Innovation: Evaluating the Evolution of Willingness-to-Pay for CAR-T Therapies in Germany () -  Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_3178;    
    Indeed, the most recent launch, ciltacabtagene autoleucel , obtained the highest launch price to date, and has thus far maintained this price post-AMNOG. For brexucabtagene autoleucel , with the lowest launch price, parity to the most expensive CAR-T with the same indication was still possible.
  • ||||||||||  Breyanzi (lisocabtagene maraleucel) / BMS
    Journal, Real-world evidence, Real-world:  Comparative efficacy of lisocabtagene maraleucel in the PILOT study versus second-line chemotherapy regimens in the real world. (Pubmed Central) -  Oct 31, 2024   
    P2
    After using the trimmed stabilized inverse probability of treatment weighting method to balance cohorts according to baseline characteristics, there were statistically significant differences in all tested measures of efficacy. Compared with real-world conventional chemotherapy regimens, liso-cel demonstrated higher overall response rates (79.6% with liso-cel vs. 50.5% with conventional chemotherapy; relative risk [RR], 1.6; P.
  • ||||||||||  Journal, Adverse events, CAR T-Cell Therapy, Real-world evidence, Real-world:  Neurotoxicity associated with chimeric antigen receptor T-cell therapy: a real-world study leveraging the FDA Adverse Event Reporting System. (Pubmed Central) -  Oct 16, 2024   
    For instance, paraparesis, cerebral hemorrhage, impaired pupillary reflex, Guillain-Barre syndrome, brain death following tisagenlecleucel; dysarthria, orthostatic hypotension, and spinal cord edema after axicabtagene; parkinsonism, Bell's palsy, and cranial nerve paralysis post ciltacabtagene. Axicabtagene ciloleucel, tisagenlecleucel, brexucabtagene autoleucel, lisocabtagene maraleucel, idecabtagene vicleucel, and ciltacabtagene autoleucel exhibited increased odds of neurotoxicity, with some discrepancies in their characteristics, profiles, and severity.
  • ||||||||||  Breyanzi (lisocabtagene maraleucel) / BMS, Tecartus (brexucabtagene autoleucel) / Gilead, Yescarta (axicabtagene ciloleucel) / Gilead
    MODULE 3: CAR T-Cell Therapy for Other Lymphoma Subtypes (Manchester Grand Hyatt San Diego, Seaport Ballroom ABCD; In-Person; Virtual) -  Oct 5, 2024 - Abstract #ASH2024ASH_135;    
    Active, not recruiting --> Recruiting This program is supported by educational grants from Bristol Myers Squibb, Genentech, a member of the Roche Group and Regeneron Pharmaceuticals Inc.Principal outcomes with the approved CAR T-cell platforms axi-cel, tis-cel and liso-cel for R/R follicular lymphoma (FL) Optimal incorporation of axi-cel, tis-cel and liso-cel into FL management algorithms Key clinical research findings with brexucabtagene autoleucel and optimal integration into the mantle cell lymphoma (MCL) treatment paradigm Design, eligibility criteria and major efficacy and safety outcomes from the MCL cohort of the pivotal Phase I TRANSCEND NHL 001 trial; recent FDA approval of liso-cel for R/R MCL
  • ||||||||||  Breyanzi (lisocabtagene maraleucel) / BMS, Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
    MODULE 1: Chimeric Antigen Receptor (CAR) T-Cell Therapy for Diffuse Large B-Cell Lymphoma (DLBCL) (Manchester Grand Hyatt San Diego, Seaport Ballroom ABCD; In-Person; Virtual) -  Oct 5, 2024 - Abstract #ASH2024ASH_133;    
    This program is supported by educational grants from Bristol Myers Squibb, Genentech, a member of the Roche Group and Regeneron Pharmaceuticals Inc.Principal outcomes with the approved CAR T-cell platforms axi-cel, tis-cel and liso-cel for R/R follicular lymphoma (FL) Optimal incorporation of axi-cel, tis-cel and liso-cel into FL management algorithms Key clinical research findings with brexucabtagene autoleucel and optimal integration into the mantle cell lymphoma (MCL) treatment paradigm Design, eligibility criteria and major efficacy and safety outcomes from the MCL cohort of the pivotal Phase I TRANSCEND NHL 001 trial; recent FDA approval of liso-cel for R/R MCL This program is supported by educational grants from Bristol Myers Squibb, Genentech, a member of the Roche Group and Regeneron Pharmaceuticals Inc.Factors influencing patient eligibility for CAR T-cell therapy, such as age, performance status, comorbidities and prior therapies Long-term efficacy and safety data with axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tis-cel) and lisocabtagene maraleucel (liso-cel) for multiregimen-relapsed DLBCL Major findings from Phase III studies of CAR T-cell therapy as second-line treatment for DLBCL FDA approvals of axi-cel and liso-cel as second-line therapy and identification of candidates for this strategy Available data (eg, from the ZUMA-12 trial) and ongoing research with CAR T-cell therapy in the up-front setting Early results with and ongoing investigation of other CAR T-cell platforms in the treatment of DLBCL
  • ||||||||||  MODULE 5: Chimeric Antigen Receptor (CAR) T-Cell Therapy and Other Novel Strategies for CLL (Manchester Grand Hyatt San Diego, Seaport Ballroom EFGH; In-Person; Virtual) -  Oct 5, 2024 - Abstract #ASH2024ASH_79;    
    This program is supported by educational grants from Bristol Myers Squibb, Genentech, a member of the Roche Group and Regeneron Pharmaceuticals Inc.Factors influencing patient eligibility for CAR T-cell therapy, such as age, performance status, comorbidities and prior therapies Long-term efficacy and safety data with axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tis-cel) and lisocabtagene maraleucel (liso-cel) for multiregimen-relapsed DLBCL Major findings from Phase III studies of CAR T-cell therapy as second-line treatment for DLBCL FDA approvals of axi-cel and liso-cel as second-line therapy and identification of candidates for this strategy Available data (eg, from the ZUMA-12 trial) and ongoing research with CAR T-cell therapy in the up-front setting Early results with and ongoing investigation of other CAR T-cell platforms in the treatment of DLBCL This program is supported by educational grants from AstraZeneca Pharmaceuticals LP, BeiGene Ltd and Eli Lilly.Biological rationale for the investigation of CD19- directed CAR T-cell therapy for CLL Published efficacy and safety findings with lisocabtagene maraleucel (liso-cel) for R/R CLL from the Phase I/II TRANSCEND CLL 004 trial FDA approval of liso-cel for CLL previously treated with a BTK inhibitor and a Bcl-2 inhibitor; current clinical role and optimal patient selection Early findings with other CAR T-cell-based approaches (eg, liso-cel in combination with ibrutinib, brexucabtagene autoleucel, rapcabtagene autoleucel) for heavily pretreated CLL Antitumor activity observed with bispecific antibody therapy (eg, epcoritamab, NVG-111, LAVA-051) for CLL, including in patients with Richter's transformation Other promising agents and strategies under investigation for CLL
  • ||||||||||  Practical Challenges in Korea (Room C (1F)) -  Sep 24, 2024 - Abstract #ICBMT2024ICBMT_191;    
    Although the United States Food and Drug Administration (US FDA) has approved six CAR T-cell therapies (axicabtagene ciloleucel, brexucabtagene autoleucel, idecabtagene vicleucel, lisocabtagene maraleucel, tisagenlecleucel, and ciltacabtagene autoleucel), only one (tisa-cel) is currently available in Korea. This session will explore the practical challenges surrounding CAR T-cell therapy in South Korea, including patient accessibility, cost-related concerns, reimbursement-related challenges, and the issue of managing CAR T-cell therapy-related toxicities.
  • ||||||||||  Changing the Treatment Landscape with CART Cells in Patients with B-Cell Lymphomas (Room C (1F)) -  Sep 24, 2024 - Abstract #ICBMT2024ICBMT_190;    
    This session will explore the practical challenges surrounding CAR T-cell therapy in South Korea, including patient accessibility, cost-related concerns, reimbursement-related challenges, and the issue of managing CAR T-cell therapy-related toxicities. So far, four CD19-directed CAR-T therapies (Yescarta
  • ||||||||||  Breyanzi (lisocabtagene maraleucel) / BMS, Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
    Choosing a CAR for Relapsed/Refractory DLBCL: Which CAR, for Whom, and When (Room B (2F)) -  Sep 24, 2024 - Abstract #ICBMT2024ICBMT_69;    
    These data support the use of CAR T-cells as the preferred 2 nd line treatment in the majority of patients with relapsed/refractory LBCL, or as 3 rd line or later treatment in patients who have not received CAR T-cell therapy in 2 nd line. Ongoing studies are evaluating moving CAR T-cells even earlier as frontline therapy in very high risk patients.