Breyanzi (lisocabtagene maraleucel) / BMS - LARVOL DELTA

Optimizing post–chimeric antigen receptor (CAR) T cell monitoring: Evidence across lisocabtagene maraleucel (liso-cel) pivotal clinical trials and real-world experience. (ASCO 2025) - P1, P1/2, P2, P3 | "Clinical Trial Registration Number: NCT02631044, NCT03331198, NCT03483103, NCT03575351, NCT04245839 The abstract will be released to the public on May 22, 2025 at 4:00 PM"

Clinical • Real-world • Real-world evidence • Chronic Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Oncology

Real world and Appalachian comparison of axicabtagene ciloleucel and lisocabtagene maraleucel in relapsed/refractory diffuse large B-cell lymphoma. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM"

Clinical • Real-world • Real-world evidence • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Matching-adjusted indirect comparison (MAIC) of lisocabtagene maraleucel (liso-cel) versus axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel) for treatment of third-line or later (3L+) R/R follicular lymphoma (FL): Update with 24 months of liso-cel follow-up (FU). (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT04245839, NCT03105336, NCT03568461 The abstract will be released to the public on May 22, 2025 at 4:00 PM"

Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

Propensity score (PS) comparison between lisocabtagene maraleucel (liso-cel) plus ibrutinib combination therapy (combo) and liso-cel monotherapy (mono) cohorts from TRANSCEND CLL. (ASCO 2025) - P1/2 | "Clinical Trial Registration Number: NCT03331198 The abstract will be released to the public on May 22, 2025 at 4:00 PM"

Combination therapy • Monotherapy • Chronic Lymphocytic Leukemia

Bristol Myers Squibb Reports First Quarter Financial Results for 2025 (Bristol-Myers Squibb) - "Growth Portfolio revenues of $5.6 billion increased 16% on a reported basis, or 18% Ex-FX. Revenue growth was primarily driven by Opdivo, Breyanzi, Reblozyl and Camzyos and reflects the strong early U.S. launch of Cobenfy."

Commercial • Cardiovascular • Chronic Lymphocytic Leukemia • CNS Disorders • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Mantle Cell Lymphoma • Melanoma • Myelodysplastic Syndrome

Matching-Adjusted Indirect Comparison of Epcoritamab With Rituximab + Lenalidomide vs Lisocabtagene Maraleucel in Second-Line Follicular Lymphoma (ICML 2025) - No abstract available

Clinical • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

PREDICTIVE FACTORS OF FAILURE OF CAR T CELLS AS A SECOND-LINE THERAPY FOR REFRACTORY OR EARLY-RELAPSING LARGE B-CELL LYMPHOMA (EHA 2025) - "Second-line axicabtagene (axi-cel) or lisocabtagene maraleucel (liso-cel) have shown durable remissions in a subset of patients, but relapses still occur...55 patients (93%) presented with DLBCL NOS, including 6 (10%) with a CNS involvement, 4 (7%) with a transformed follicular lymphoma.First-line treatment consisted of R-CHOP21 (90%) or high-dose R-CHOP-like regimen (R-ACVBP) (10%); 2 patients had prior ASCT... Key predictors of failure and mortality post-second-line CAR T-cell therapy include high LDH, TMTV (>50 cm³ for PFS, >115 cm³ for OS), >1 extranodal site, PDB, and high ferritin/CRP at D-5. Validation is ongoing via DESCART."

Biomarker • CAR T-Cell Therapy • Clinical • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

VIRTUAL PATIENT SIMULATION IMPROVES CLINICAL DECISION-MAKING IN THE MANAGEMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (EHA 2025) - "In case 1, 71% of participants ordered appropriate treatment, with 77% choosing pirtobrutinib and 60% choosing liso-cel due to favourable clinical trial data. These results demonstrate the success of immersive, online VPS education that engages physicians in a practical learning experience with improving their performance in providing personalized care for patients with R/R CLL. The results also highlight ongoing educational needs, specifically on appropriate treatment choices for patients with R/R CLL, which could be addressed in future educational activities."

Clinical • Chronic Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology

Health and Economic Impact of Vein-to-Vein Time in CAR T-Cell Therapy in the Second-Line Treatment of Relapsed/Refractory Large B-cell Lymphoma: A US Cost-Effectiveness Analysis. (PubMed, Transplant Cell Ther) - "2L treatment with axi-cel was more effective and less costly compared with liso-cel in patients with LBCL in the US. These findings suggest that reduced V2VT was associated with improved clinical and economic outcomes, and highlight the importance of short V2VT in R/R 2L LBCL CAR T treatments."

HEOR • Journal • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

ENHANCED CAR T-CELL EXPANSION AND DURABLE COMPLETE RESPONSES WITH NKTR-255 PLUS LISOCABTAGENE MARALEUCEL IN RELAPSED/REFRACTORY LARGE B-CELL LYMPHOMA (EHA 2025) - P1 | "The combination of NKTR-255 and liso-cel in R/R LBCL was well tolerated and safe. Higher CAR T-cell expansion and AUC0-28 were observed in pts treated with the OBR compared to liso-cel alone. CRs appear to be durable, with only one relapse."

CAR T-Cell Therapy • Clinical • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD8 • IL15

AUC FLUDARABINE AND PRODUCT CHOICE ARE MAIN PREDICTORS OF CRS/ICANS AFTER CAR T CELL THERAPY: GENERATION OF AN IMPROVED MODEL (EHA 2025) - "Additionally, previous studies only comprised patients treated with tisacel or axi-cel, and a few experimental products...After exclusion of gender, patient weight and brexu-cel as predictors, mEASIX, AUC fludarabine, age, liso-cel, and MM were included as predictors for ICANS>=°II... Elevated AUC fludarabine was significantly associated with severe CRS/ICANS. In contrast, lisocel and MM were associated with decreased risk. The previously reported association of mEASIX with CRS/ICANS was less pronounced in our models."

CAR T-Cell Therapy • Chronic Kidney Disease • Hematological Malignancies • Multiple Myeloma • Oncology

THREE-YEAR REAL-WORLD MORTALITY ANALYSIS OF CAR-T THERAPIES: TISA-CEL, AXI-CEL, AND LISO-CEL (EHA 2025) - "This large-scale real-world study provides valuable insights into mortality rates associated with three approved CAR-T therapies for refractory lymphomas over a three-year period. While mortality rates varied among therapies at different time points, survival analysis of DLBCL patients revealed no statistically significant differences in overall survival outcomes. These findings indicate consistent survival outcomes in real-world settings as observed in pivotal clinical trials."

Clinical • Real-world • Real-world evidence • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

MANAGEMENT OF IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME FOLLOWING CAR-T CELL THERAPY IN CLINICAL PRACTICE: A MULTICENTRIC, RETROSPECTIVE, REAL-WORLD ANALYSIS OF TREATMENT APPROACHES AND OUTCOMES (EHA 2025) - "The CAR T-cell products used were Axi-cel in 65 patients (62.5%), Brexu-cel in 15 (14.4%), Tisa-cel in 13 (12.5%), Liso-cel in 5 (4.8%), Ide-cel in 5 (4.8%), and Cilta-cel in 1 (1.0%)...Additionally, delayed initiation of corticosteroids and anakinra were strong determinants of extended ICANS duration (p5 days) was associated with inferior PFS. Early initiation of corticosteroids and IL-1 receptor antagonists was associated with shorter ICANS duration, suggesting that prompt intervention may mitigate prolonged neurotoxicity."

CAR T-Cell Therapy • Real-world • Real-world evidence • Retrospective data • Acute Lymphocytic Leukemia • B Cell Lymphoma • CNS Disorders • Epilepsy • Hematological Malignancies • Large B Cell Lymphoma • Leukemia • Lymphoma • Mantle Cell Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

OPTIMIZING POST-CHIMERIC ANTIGEN RECEPTOR T CELL MONITORING: EVIDENCE ACROSS LISOCABTAGENE MARALEUCEL PIVOTAL CLINICAL TRIALS AND REAL-WORLD EXPERIENCE (EHA 2025) - "for their 2025 ASCO Annual Meeting. This abstract is embargoed until Thursday, June 12, 2025, 08:00 CEST."

CAR T-Cell Therapy • Clinical • Real-world • Real-world evidence • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

ASSOCIATION BETWEEN BASELINE PATIENT-REPORTED OUTCOMES AND CLINICAL OUTCOMES OF CHIMERIC ANTIGEN RECEPTOR (CAR) T-CELL THERAPY (EHA 2025) - "The most frequently used CAR-T products were tisagenleccel (34%), followed by lisocabtagene maraleucel (16%), axicabtagene ciloleucel (13%), and idecabtagene vicleucel (12%). Baseline PROs are associated with OS post-CAR-T and risk of CRS and ICANS in CAR-T recipients. These findings underscore the potential utility of pre-CAR-T PROs as important prognostic factors for CAR-T outcomes."

Clinical • Clinical data • Patient reported outcomes • CNS Disorders • Depression • Hematological Disorders • Hematological Malignancies • Lymphoma • Mood Disorders • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Psychiatry

ANTI-CD19 CAR-T CELL THERAPY IN RELAPSED/REFRACTORY T-CELL/HISTIOCYTE-RICH LARGE B-CELL LYMPHOMA (THRLBCL): INSIGHTS FROM THE FRENCH DESCAR-T REGISTRY, A LYSA STUDY. (EHA 2025) - "All patients underwent lymphodepletion with fludarabine and cyclophosphamide, followed by axicabtagene ciloleucel (n=14tisagenlecleucel (n=8), or lisocabtagene maraleucel (n=1)...Among R/R patients after CAR-T cell therapy, 7 remained alive at one year, having received lenalidomide and anti-CD20 mAb (n=3), lenalidomide, ibrutinib and anti-CD20 mAb (n=1), immune checkpoint inhibitors (ICIs) and autologous stem cell transplant (n=1), ICIs alone (n=1) or a bispecific anti-CD20/CD3 mAb (n=1). Despite an overall low response rate, R/R THRLBCL patients achieving CR after anti-CD19 CAR-T cell therapy appeared to experience prolonged response durations."

CAR T-Cell Therapy • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Histiocyte Rich Large B Cell Lymphoma

IMPACT OF PRE-INFUSION CD19 EXPRESSION ON CAR T-CELL EXPANSION AND CLINICAL OUTCOMES IN R/R -B-CELL LYMPHOMA. (EHA 2025) - "All available commercialized CAR T-cells for lymphomas including axicabtagene (axi-cel), tisagenlecleucel (tisa-cel) or lisocabtagene maraleucel (liso-cel) are designed to target CD19. Loss of detectable CD19 in pre-infusion lymphoma biopsy represents only few cases, accounting for less than 10% of the analyzed cohort. Interestingly, CD19-negative expression in lymphoma biopsy did not impact CAR T-cell expansion. However, all the evaluable patients with a CD19-negative expression experienced a relapse."

CAR T-Cell Therapy • Clinical • Clinical data • IO biomarker • B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Mantle Cell Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Septic Shock • CD19

MATCHING-ADJUSTED INDIRECT COMPARISON OF LISOCABTAGENE MARALEUCEL VERSUS AXICABTAGENE CILOLEUCEL AND TISAGENLECLEUCEL FOR TREATMENT OF THIRD-LINE OR LATER R/R FL: UPDATE WITH 24 MONTHS OF FOLLOW-UP (EHA 2025) - "for their 2025 ASCO Annual Meeting. This abstract is embargoed until Thursday, June 12, 2025, 08:00 CEST.Presentation during EHA2025: All (e)Poster presentations will be made available as of Thursday, June 12, 2025 (08:00 CEST) will be accessible for on-demand viewing from June 18 to August 15, 2025 on the Congress platform."

Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

BOOM-BOOM RADIATION PRIOR TO LISOCABTAGENE MARALEUCEL IS FEASIBLE AND CONTRIBUTES TO HIGH COMPLETE RESPONSE RATES FOR AGGRESSIVE B-CELL NON-HODGKIN LYMPHOMA (EHA 2025) - "The combination of BOOM-BOOM RT and liso-cel met our primary endpoint of feasibility and produced a high CR rate of 83%. Although median follow-up is short, PFS and OS outcomes are encouraging. These data suggest that the use of low-dose RT as bridging therapy is safe, feasible, and may be effective at enhancing outcomes to liso-cel therapy."

Clinical • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Gastrointestinal Disorder • Hematological Malignancies • High-grade B-cell lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Richter's Syndrome • Septic Shock

“Based on the assessment of the PSUR, PRAC reviewed the benefit-risk balance of Breyanzi, the benefit-risk balance of Breyanzi (lisocabtagene maraleucel) in the approved indication(s) remains unchanged” (European Medicines Agency) - Pharmacovigilance Risk Assessment Committee (PRAC) Minutes of meeting on 10 – 13 Mar 2025: “Nevertheless, the product information should be updated to amend the warning regarding virus reactivation by adding reactivation of John Cunningham virus leading to progressive multifocal leukoencephalopathy (PML). Therefore, the current terms of the marketing authorization(s) should be varied”

PRAC • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Mediastinal B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

Hematologic and lymphatic disorders associated with chimeric antigen receptor T-cell therapy: a pharmacovigilance analysis of the FDA adverse event reporting system (FAERS) database. (PubMed, BMC Cancer) - "Our study found that hematologic and lymphatic system AEs were more closely associated with anti-CD19 CAR-T and CAR-T containing CD28. Splenic hemorrhage, disseminated intravascular coagulation, and pancytopenia were identified as hematologic and lymphatic system AEs that, while less frequently reported clinically, were highly associated with mortality."

Adverse events • Journal • Aplastic Anemia • Hematological Disorders • Oncology

"The pan-Canadian Oncology Drug Review Expert Review Committee (pERC) recommends that lisocabtagene maraleucel (liso-cel) be reimbursed for adults with DLBCL not otherwise specified, PMBCL, HGBCL, and DLBCL arising from follicular lymphoma, who have disease that is refractory to first-line chemoimmunotherapy or who experience relapse within 12 months of first-line chemoimmunotherapy…" (Ottawa (ON): Canadian Agency for Drugs and Technologies in Health)

Reimbursement • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma

Phase 2 trial of lisocabtagene maraleucel (liso–cel) in combination with acalabrutinib in relapsed/refractory large B–cell lymphomas (LBCL) (ICML 2025) - No abstract available

Combination therapy • P2 data • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Infusion stays and costs for patients treated with axi-cel or liso-cel for second-line large B-cell lymphoma in France: differences from comprehensive hospital databases (ICML 2025) - No abstract available

Clinical • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Enhanced CAR T–cell Expansion and Durable Complete Responses with NKTR–255 Plus Lisocabtagene Maraleucel in Relapsed/Refractory Large B–cell Lymphoma (ICML 2025) - No abstract available

CAR T-Cell Therapy • Clinical • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology