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    DRUG:

    Breyanzi (lisocabtagene maraleucel)

    i
    Other names: JCAR017, anti-CD19-EGFRt-4-1BB-zeta modified CAR CD8+ and CD4+ T lymphocyte therapy, CD19-CAR T cell immunotherapy, CD19 specific CAR T cells also expressing an EGFRt, anti-CD19/EGFRt/4-1BB/zeta modified CAR CD8+ and CD4+ T lymphocyte therapy, JCAR 017, liso-cel, JCAR-017
    Company:
    BMS
    Drug class:
    CD19-targeted CAR-T immunotherapy
    Related drugs:
    5d
    Ph I/II Study of E7777 Prior to CAR-T for R/R LBCL (clinicaltrials.gov)
    P1/2, N=30, Suspended, Masonic Cancer Center, University of Minnesota | Trial completion date: Dec 2025 --> Dec 2026 | Recruiting --> Suspended | Trial primary completion date: Dec 2025 --> Sep 2026
    Trial completion date • Trial suspension • Trial primary completion date
    |
    MYC (V-myc avian myelocytomatosis viral oncogene homolog) • BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
    |
    LDH elevation
    |
    cyclophosphamide • Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Kymriah (tisagenlecleucel-T) • fludarabine IV • Lymphir (denileukin diftitox-cxdl)
    7d
    Impact of CD5 expression on outcomes for chimeric antigen receptor-T cell therapy in relapsed and refractory diffuse large B-cell lymphoma. (PubMed, Cytotherapy)
    To investigate this clinical issue, 106 patients treated with CAR-T cell therapy using either tisagenlecleucel, lisocabtagene maraleucel or axicabtagene ciloleucel for r/r DLBCL at our institution were retrospectively analyzed. Multivariate analysis revealed that CD5 expression was unfavorably associated with PFS and OS. Together, these data suggest that CD5 expression has a negative impact on outcomes after CAR-T cell therapy.
    Journal • IO biomarker
    |
    CD5 (CD5 Molecule)
    |
    Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Kymriah (tisagenlecleucel-T)
    11d
    Nemtabrutinib and Lisocabtagene Maraleucel for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (clinicaltrials.gov)
    P2, N=20, Not yet recruiting, Fred Hutchinson Cancer Center | Initiation date: Dec 2025 --> Apr 2026
    Trial initiation date
    |
    cyclophosphamide • Breyanzi (lisocabtagene maraleucel) • nemtabrutinib (MK-1026)
    15d
    Phase 2 Trial of Lisocabtagene Maraleucel for Minimal Residual Disease in Patients With Large B-cell Lymphoma (clinicaltrials.gov)
    P2, N=10, Not yet recruiting, M.D. Anderson Cancer Center
    New P2 trial • Minimal residual disease
    |
    BCL2 (B-cell CLL/lymphoma 2)
    |
    Foresight CLARITY™
    |
    Breyanzi (lisocabtagene maraleucel)
    1m
    Lisocabtagene Maraleucel, Nivolumab and Ibrutinib for the Treatment of Richter's Transformation (clinicaltrials.gov)
    P2, N=20, Recruiting, City of Hope Medical Center | Trial completion date: Sep 2025 --> Sep 2026 | Trial primary completion date: Sep 2025 --> Sep 2026
    Trial completion date • Trial primary completion date
    |
    clonoSEQ
    |
    Opdivo (nivolumab) • Imbruvica (ibrutinib) • cyclophosphamide • Breyanzi (lisocabtagene maraleucel) • fludarabine IV
    1m
    Immune Effector Cell-Associated HLH-Like Syndrome (IEC-HS) in CAR-T and TCE-Treated Myeloma and B-Cell Malignancies: Insights from a Pharmacovigilance Study. (PubMed, Transplant Cell Ther)
    IEC-HS is a rare but potentially fatal complication. Our disproportionality analysis identifies significant reporting signals for tisa-cel and cilta-cel. The high absolute number of cases observed for products like axi-cel appears to reflect high utilization rather than a disproportionate risk, underscoring the necessity of using statistical signal detection methods when interpreting spontaneous reports.
    Journal • Adverse events
    |
    ROR1 (Receptor Tyrosine Kinase Like Orphan Receptor 1)
    |
    Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Kymriah (tisagenlecleucel-T) • Epkinly (epcoritamab-bysp) • Elrexfio (elranatamab-bcmm) • Tecartus (brexucabtagene autoleucel) • Abecma (idecabtagene vicleucel) • Carvykti (ciltacabtagene autoleucel) • Lunsumio (mosunetuzumab-axgb) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv) • Columvi (glofitamab-gxbm)
    1m
    Emerging role of lisocabtagene maraleucel chimeric antigen receptor-T cell in nodal and gastrointestinal follicular lymphoma. (PubMed, World J Gastroenterol)
    Comparative insights highlight the advantages of liso-cel over other CAR-T cell products, such as axicabtagene ciloleucel and tisagenlecleucel in terms of toxicity, logistics, and outpatient feasibility. With ongoing improvements in manufacturing, accessibility, and biomarker development, liso-cel is well-positioned to become a central component in the evolving treatment paradigm for FL. However, challenges remain regarding durability of response, cost, and access, which warrant careful discussion.
    Review • Journal • IO biomarker
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Kymriah (tisagenlecleucel-T)
    1m
    PiNACLE-H2H: A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy (clinicaltrials.gov)
    P3, N=400, Recruiting, Lyell Immunopharma, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • rondecabtagene autoleucel (LYL314)
    1m
    NT-I7 (Efineptakin Alfa), a Long-acting Human IL-7, Post-Yescarta® (Axicabtagene Ciloleucel) or Post-Breyanzi® (Lisocabtagene Maraleucel) in Subjects With Relapsed/Refractory Large B-cell Lymphoma (clinicaltrials.gov)
    P1, N=24, Not yet recruiting, Washington University School of Medicine | Trial completion date: Apr 2028 --> Aug 2028 | Initiation date: Oct 2025 --> Feb 2026 | Trial primary completion date: Jul 2027 --> Nov 2027
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Hyleukin-7 (efineptakin alfa)
    2ms
    Peripheral Blood CD4/CD8 Ratio Predicts Out-of-Specification Products in Lisocabtagene Maraleucel Manufacturing. (PubMed, Cancer Rep (Hoboken))
    Our findings suggest that a low CD4/CD8 ratio (below one-third) may be a predictive marker for OOS outcomes, potentially supporting patient selection and treatment planning. Therefore, prospective validation using a larger cohort is warranted.
    Retrospective data • Journal
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    Breyanzi (lisocabtagene maraleucel)
    2ms
    A Study of the Efficacy and Safety of Lisocabtagene Maraleucel (Liso-cel) as First-Line Therapy in Adults With Transplant-Ineligible Primary Central Nervous System Lymphoma (clinicaltrials.gov)
    P2, N=65, Recruiting, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Rituxan (rituximab) • temozolomide • cyclophosphamide • Breyanzi (lisocabtagene maraleucel) • leucovorin calcium • fludarabine IV • Matulane (procarbazine hydrochloride)
    3ms
    TRANSCEND FL: A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL) (clinicaltrials.gov)
    P2, N=276, Active, not recruiting, Celgene | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    cyclophosphamide • Breyanzi (lisocabtagene maraleucel) • fludarabine IV