Abecma (idecabtagene vicleucel) / BMS, 2seventy bio - LARVOL DELTA

Comparative assessment of colitis-related adverse events in multiple myeloma patients treated with teclistamab, ciltacabtagene, and idecabtagene: Incidence, outcomes, and risk assessment. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Adverse events • Clinical • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Immunology • Multiple Myeloma • Oncology

Comparative efficacy of idecabtagene vicleucel and ciltacabtagene autoleucel in relapsed/refractory multiple myeloma: Real-world analysis of overall survival and time to next treatment. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Real-world • Real-world evidence • Hematological Malignancies • Multiple Myeloma • Oncology

Outpatient administration of idecabtagene vicleucel in relapsed refractory multiple myeloma without planned prophylaxis or remote monitoring. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Hematological Malignancies • Multiple Myeloma • Oncology

Impact of autoimmune disease on toxicity and outcomes after idecabtagene vicleucel in patients with multiple myeloma. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Hematological Malignancies • Immunology • Multiple Myeloma • Oncology

Absolute lymphocyte count after CAR-T therapy has different kinetics and predicts better outcomes in B-cell malignancies (AACR 2025) - "Introduction: Chimeric antigen receptor (CAR) T-cell therapy targeting CD19 and BCMA antigens are now a valuable option for patients with relapsed or refractory (R/R) B-Cell malignancies Commercially available products consist of an antigen binding domain against CD19 or BCMA and one of two main co-stimulatory molecules, CD28 (Axi-Cel , Brexu-Cel ) and 41-BB (Tisa-Cel, Liso-Cel, Cilta-cel, and Ide-cel). ALCmax was associated with better PFS in DLBCL patients treated with both types of CD19 products and in MM patients treated with BCMA-41-BB CAR-T products. This data suggests that ALCmax is a good marker for response to CAR-T therapy and encourages better understanding of the factors influencing ALC levels between the CAR-T products and disease subtypes."

IO biomarker • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Oncology

Advancing Equity in CAR T-Cell Therapy: An Analysis of Health Technology Assessments by Canada's Drug Agency and the National Institute for Health and Care Excellence (ISPOR 2025) - "This review examines if and how health technology assessments (HTAs) by Canada's Drug Agency (CDA) and the National Institute for Health and Care Excellence (NICE) consider equity in evaluating CAR T-cell therapies. HTA reports from CDA and NICE for six CAR T-cell therapies (Abecma, Breyanzi, Carvykti, Kymriah, Tecartus, Yescarta) were reviewed by two researchers for equity considerations related to access disparities, capacity, socioeconomic determinants, and related clinical and economic evidence. This review identified that DEI considerations related to CAR T-cell therapy access like patient costs and geographical barriers were not routinely supported by evidence in CDA and NICE submissions. Evidence generation challenges in CAR-T therapy may inadvertently deprioritize equity concerns. Recent commitments to equity from HTA bodies offer opportunities to ensure fair access to novel, high-cost therapies."

CAR T-Cell Therapy • Reimbursement • US reimbursement • Hematological Disorders • Hematological Malignancies • Oncology

Does the Occurrence of ICANS After CAR-T Therapy Increase the Risk of Late Neurological Complications: A Real-World Data Analysis (ASGCT 2025) - "A total of 4,700 patients in this dataset received one of the US FDA-approved CAR-T therapies, including axicabtagene ciloleucel, tisagenlecleucel, lisocabtagene maraleucel, brexucabtagene autoleucel, and idecabtagene vicleucel. Future studies should consider potential confounding factors including age, prior cancer treatment, and underlying cancer type which could impact the risk of developing neurodegenerative disorders after CAR-T. Disease Focus of Abstract:Central Nervous System Disorders"

Clinical • Real-world • Real-world evidence • CNS Disorders • Movement Disorders • Oncology • Parkinson's Disease

Use of Novel Therapies for Multiple Myeloma in the United States: Important Differences in Patient Characteristics, Access to Care, and Real-World Treatment Challenges (ISPOR 2025) - "All pts had ≥1 claim for a CAR-T/BsAb tx including idecabtagene vicleucel, ciltacabtagene autoleucel, teclistamab, talquetamab, or elranatamab, and continuous enrollment ≥90 days before and after index date. Of the 2,442 pts included, 61% received BsAbs and 39% received CAR-Ts. Descriptively, these results suggest important differences in sociodemographic and clinical characteristics among pts who received novel tx for MM. Uptake of BsAbs was higher compared to CAR-Ts, indicating greater tx accessibility for BsAbs. This warrants further investigation into barriers to access and strategies to potentially ameliorate existing health disparities in U.S. MM pts."

Clinical • HEOR • Real-world • Real-world evidence • Hematological Malignancies • Multiple Myeloma • Oncology

Characteristics of RWE used in Regulatory Decision-Making for Marketing Authorization Applications (MAAs) (ISPOR 2025) - "Descriptive analyses were performed to identify trends in the characteristics of drugs and of the RWE. Seven medicines were analyzed: idecabtagene vicleucel (ide-cel), omburtamab, sotorasib, alpelisib, palovarotene, tacrolimus, and omaveloxolone. MAAs containing RWE submitted to the FDA were predominantly for rare diseases medicines and for first-in-class indications. Acceptability of RWE varied based on entire body of evidence. Further investigation into factors influencing RWE acceptability and its integration into MAAs across other regulators such as EMA is warranted."

Hematological Disorders • Rare Diseases

Distinct expansion, phenotype, function, and toxicity of cilta-cel vs. ide-cel CAR T cells in the real world (AACR 2025) - "This first report of in-depth, comparative patient biomonitoring following real-world cilta-cel or ide-cel therapy highlights intrinsic biological differences between these BCMA-targeting CAR T products, potentially explaining differences in clinical activity and toxicity. Our findings may guide the optimization of cellular immunotherapy strategies in myeloma patients."

CAR T-Cell Therapy • Clinical • IO biomarker • Real-world • Real-world evidence • Hematological Malignancies • Multiple Myeloma • Oncology • CD27 • CD4

Cytomegalovirus Retinitis During Idecabtagene Vicleucel Therapy in Patients With Relapsed/Refractory Multiple Myeloma. (PubMed, Transpl Infect Dis) - "CMV retinitis is a significant complication of ide-cel therapy. Regular CMV PCR is important, but early ophthalmological consultations are crucial for timely detection and management, even in the absence of CMV replication, particularly when visual impairment develops. Further studies are needed to identify the risk factors and establish preventive strategies."

Journal • Cytomegalovirus Infection • Genetic Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Ocular Inflammation • Oncology • Ophthalmology • Retinal Disorders

CAR-T for multiple myeloma: practice pearls. (PubMed, Bone Marrow Transplant) - "The CAR-T cell products ciltacabtagene autoleucel and idecabtagene vicleucel have transformed the management of patients with multiple myeloma. Here, we present a practical guide highlighting clinical pearls on the incorporation of CAR-T into clinical practice. Topics addressed include expected outcomes, recommendations for referral timing, bridging therapy, treatment complications, therapeutic sequencing, and management of relapse."

Journal • Review • Hematological Malignancies • Multiple Myeloma • Oncology

KarMMa-9: A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation (clinicaltrials.gov) - P3 | N=618 | Active, not recruiting | Sponsor: Celgene | Trial completion date: Jul 2032 ➔ Aug 2025 | Trial primary completion date: Mar 2031 ➔ Aug 2025

Trial completion date • Trial primary completion date • Bone Marrow Transplantation • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

Economic Impact of Elranatamab for Treatment of Patients with Relapsed or Refractory Multiple Myeloma. (PubMed, Clinicoecon Outcomes Res) - "Total cost of care per month of median PFS over one year was $19,642 with elranatamab, talquetamab ($33,391), teclistamab ($37,791), selinexor plus dexamethasone ($48,784), physician's choice of treatment ($65,886), idecabtagene vicleucel ($78,361), and ciltacabtagene autoleucel ($17,640). Elranatamab for RRMM is projected to result in a minimal to small budget impact over 3 years and good economic value with lower cost of care per month of PFS compared with other available RRMM treatments except for ciltacabtagene autoleucel."

HEOR • Journal • Hematological Malignancies • Multiple Myeloma • Oncology

Standard-of-Care Idecabtagene Vicleucel for Relapsed/Refractory Multiple Myeloma: A CIBMTR Analysis. (PubMed, Blood) - "This is the largest real-world study of ide-cel CAR-T cell therapy in pts with RRMM. We observed a favorable safety and efficacy profile that mirrors trial experience, even in the setting of significant co-morbidities in 77% of patients, many of which would have made them ineligible for the registrational KarMMa clinical trial."

Journal • CNS Disorders • Hematological Malignancies • Infectious Disease • Movement Disorders • Multiple Myeloma • Oncology • Parkinson's Disease

Longitudinal analysis of gut microbiome and metabolome correlates of response and toxicity with idecabtagene vicleucel. (PubMed, Blood Adv) - "Additionally, network analysis and mass spectrometric assessment of stool metabolites revealed important associations and pathways, such as Flavonifractor plautii being linked to increased indole metabolites and pathways in responders. Our findings uncover novel microbiome associations between ide-cel responses and toxicities that may be useful for developing modalities to improve CAR-T outcomes."

Journal • Hematological Malignancies • Inflammation • Multiple Myeloma • Oncology

ANALYSIS OF MAJOR ADVERSE CARDIAC EVENTS (MACE) AND SURVIVAL OUTCOMES BY CAR-T SUBTYPE: CD-19 VERSUS BCMA DIRECTED THERAPY IN LYMPHOMA AND MULTIPLE MYELOMA PATIENTS (EBMT 2025) - " A single-center retrospective comparative cohort study was performed in R/R MM and B-cell lymphoma patients treated with FDA approved CD19-directed (axicabtagene ciloleucel/lisocabtagene maraleucel) and BCMA-directed CAR-T cells (idecabtagene vicleucel/ciltacabtagene autoleucel). Cardiovascular toxicity as measured by MACE was present in approximately 50% of patients with arrythmias as the most frequent event. Though numerically higher for CD19 CAR-T there was no significant difference between CAR-T cohorts per targeted antigens. Additionally, no difference was found in cardiovascular or all-cause readmissions, CRS incidence, or Tocilizumab utilization.Conversely, BCMA CAR-T therapy demonstrated a higher risk of earlier mortality in comparison to CD19 CAR-T therapy and a more profound decrease of fibrinogen levels during treatment.Further research is warranted to explore the relationship between CAR-T therapy and cardiovascular toxicities including the underlying..."

Adverse events • Clinical • IO biomarker • Acute Coronary Syndrome • B Cell Lymphoma • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Malignancies • Lymphoma • Multiple Myeloma • Myocardial Infarction • Non-Hodgkin’s Lymphoma • Oncology • CRP

ANALYSIS OF MAJOR ADVERSE CARDIAC EVENTS (MACE) AND SURVIVAL OUTCOMES BY CAR-T SUBTYPE: CD-19 VERSUS BCMA DIRECTED THERAPY IN LYMPHOMA AND MULTIPLE MYELOMA PATIENTS (EBMT 2025) - " A single-center retrospective comparative cohort study was performed in R/R MM and B-cell lymphoma patients treated with FDA approved CD19-directed (axicabtagene ciloleucel/lisocabtagene maraleucel) and BCMA-directed CAR-T cells (idecabtagene vicleucel/ciltacabtagene autoleucel). Cardiovascular toxicity as measured by MACE was present in approximately 50% of patients with arrythmias as the most frequent event. Though numerically higher for CD19 CAR-T there was no significant difference between CAR-T cohorts per targeted antigens. Additionally, no difference was found in cardiovascular or all-cause readmissions, CRS incidence, or Tocilizumab utilization.Conversely, BCMA CAR-T therapy demonstrated a higher risk of earlier mortality in comparison to CD19 CAR-T therapy and a more profound decrease of fibrinogen levels during treatment.Further research is warranted to explore the relationship between CAR-T therapy and cardiovascular toxicities including the underlying..."

Adverse events • Clinical • IO biomarker • Acute Coronary Syndrome • B Cell Lymphoma • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Malignancies • Lymphoma • Multiple Myeloma • Myocardial Infarction • Non-Hodgkin’s Lymphoma • Oncology • CRP

TRACKING THE PATIENT QUALITY OF LIFE JOURNEY WITH PROMIS-29 AFTER CHIMERIC ANTIGEN RECEPTOR T CELL THERAPY (EBMT 2025) - " From May 2019 to December November 2024, 622 patients (median age of 66 (20-88) underwent commercial CAR T (70% non-Hodgkin lymphoma (NHL), 27% multiple myeloma (MM), 3% acute lymphoblastic lymphoma (ALL); 33% axi-cel, 20% liso-cel, 14% tisa-cel, 7% brexu-cel, 18% cilta-cel, 9% ide-cel). Most patients (87%) received cyclophosphamide/fludarabine lymphodepletion, with 10% receiving bendamustine and 2% cyclophosphamide alone... Standard of care use of PROMIS-29 over an electronic platform was possible, though efforts are needed to improve response rates. Variability in summary and domain scores existed between products and timepoints, though most patients who answered showed improvement from standardized norms over time. This data can serve as a baseline for future interventions."

CAR T-Cell Therapy • Clinical • HEOR • Acute Lymphocytic Leukemia • CNS Disorders • Fatigue • Hematological Malignancies • Lymphoma • Mood Disorders • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Pain • Psychiatry • Sleep Disorder

MT2017-45: CAR-T Cell Therapy for Heme Malignancies (clinicaltrials.gov) - P2 | N=144 | Active, not recruiting | Sponsor: Masonic Cancer Center, University of Minnesota | Phase classification: P ➔ P2

Phase classification • Acute Lymphocytic Leukemia • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Large B Cell Lymphoma • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma • CD19

CILTA-CEL OR IDE-CEL AND RESPONSE DYNAMICS IN RELAPSED REFRACTORY MULTIPLE MYELOMA: A REAL-WORD ANALYSIS OF DRST/DSMM/GMMG (EBMT 2025) - "Overall, cilta-cel demonstrated a greater capacity for response conversion and durable remission, making it a compelling option for RRMM treatment, especially for patients with suboptimal pre-treatment response. These findings underscore the need for individualized CAR-T therapy selection to optimize patient outcomes."

Hematological Malignancies • Inflammation • Multiple Myeloma • Oncology

IGM RECOVERY AS A SURROGATE OF EFFECTIVENESS AFTER CAR-T THERAPY FOR RELAPSED AND REFRACTORY MULTIPLE MYELOMA – A SINGLE INSTITUTION RETROSPECTIVE ANALYSIS (EBMT 2025) - "Background: KarMMa-3 trial showed significantly better outcomes in patients with relapsed and refractory multiple myeloma (RRMM) treated with ide-cel than in patients treated with standard of care...As bridging therapy, chemotherapy-based regimen (including VTD-PACE or DCEP) was used for 63% of patients, while others received daratumumab-based, isatuximab-based, carfilzomib-based, or ixazomib-based regimen... Clinical outcomes of our cohort were better than KarMMa-3 study, although follow-up period was not long enough. The reason for better PFS can be due to the administration of conventional chemotherapy as bridging therapy. Better outcome of patients with IgM recovery may be resulted from profound immune reconstitution."

Retrospective data • Hematological Malignancies • Inflammation • Multiple Myeloma • Oncology

SEQUENTIAL BCMA CAR-T CELL THERAPY IS SAFE AND EFFICACIOUS IN REFRACTORY MULTIPLE MYELOMA IN A REAL-WORLD SETTING (EBMT 2025) - "Remarkably, all patients with long-term remissions to ide-cel (≥ 1 year) obtained durable responses to cilta-cel and were still in remission at last follow up whereas short-lived responses to ide-cel seem to predict lower DOR to cilta-cel.Patients relapsing after cilta-cel had unfavorable prognosis and did not durably respond to salvage therapies including cevostamab, talquetamab and Pom-PACE.Extended follow-up and detailed treatment data including two more patients will be presented at the meeting. Notwithstanding potential logistical challenges and financial toxicity, our data indicates that sequential BCMA-CART therapy using commercially available products is safe and elicits durable responses in a sizable number of patients, especially in those who durably responded to first the first CART product. Responses to cilta-cel as second CART product seem comparable to those published in a recent real-word analysis (Sidana et al., Blood 2024)."

CAR T-Cell Therapy • Clinical • IO biomarker • Real-world • Real-world evidence • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Oncology

SEQUENTIAL BCMA CAR-T CELL THERAPY IS SAFE AND EFFICACIOUS IN REFRACTORY MULTIPLE MYELOMA IN A REAL-WORLD SETTING (EBMT 2025) - "Remarkably, all patients with long-term remissions to ide-cel (≥ 1 year) obtained durable responses to cilta-cel and were still in remission at last follow up whereas short-lived responses to ide-cel seem to predict lower DOR to cilta-cel.Patients relapsing after cilta-cel had unfavorable prognosis and did not durably respond to salvage therapies including cevostamab, talquetamab and Pom-PACE.Extended follow-up and detailed treatment data including two more patients will be presented at the meeting. Notwithstanding potential logistical challenges and financial toxicity, our data indicates that sequential BCMA-CART therapy using commercially available products is safe and elicits durable responses in a sizable number of patients, especially in those who durably responded to first the first CART product. Responses to cilta-cel as second CART product seem comparable to those published in a recent real-word analysis (Sidana et al., Blood 2024)."

CAR T-Cell Therapy • Clinical • IO biomarker • Real-world • Real-world evidence • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Oncology

DISTINCT EXPANSION, PHENOTYPE, FUNCTION, AND TOXICITY OF CILTA-CEL VS. IDE-CEL CAR T CELLS IN THE REAL WORLD (EBMT 2025) - "This first report of in-depth, comparative patient biomonitoring following real-world cilta-cel or ide-cel therapy highlights intrinsic biological differences between these BCMA-targeting CAR T products, potentially explaining differences in clinical activity and toxicity. Our findings may guide the optimization of cellular immunotherapy strategies in myeloma patients."

CAR T-Cell Therapy • Clinical • IO biomarker • Real-world • Real-world evidence • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Oncology • CD27 • CD4