Abecma (idecabtagene vicleucel) / BMS - LARVOL DELTA

Ciltacabtagene Autoleucel versus Idecabtagene Vicleucel for Treatment of Patients with Relapsed or Refractory Multiple Myeloma: A Systematic Review and Meta-analysis (ESMO 2025) - No abstract available

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

From Trials to Practice: A 2025 Review of Idecabtagene Vicleucel and Ciltacabtagene Autoleucel Efficacy Across Clinical Studies and Real-World Evidence. (PubMed, Eur J Haematol) - "Key toxicities include cytokine release syndrome (CRS) and neurotoxicity, with emerging concerns regarding delayed neurotoxicities, second primary malignancies, and IEC-enterocolitis. This review provides a detailed analysis of recent clinical trial data, the reported outcomes of real-world published evidence, and the changing role of these therapies within the myeloma treatment paradigm, including challenges, gaps in knowledge, potential barriers to accessibility, and future directions aimed at optimizing the efficacy and safety of CAR T-cell therapy for MM patients."

HEOR • Journal • Real-world evidence • Review • Gastrointestinal Disorder • Hematological Malignancies • Multiple Myeloma • Oncology

Elranatamab for Relapsed/Refractory Multiple Myeloma With Severe Renal Impairment Requiring Hemodialysis. (PubMed, Hematol Oncol) - "To illustrate this issue, we introduce the case of a 68-year-old female with triple-class RRMM and end-stage renal disease requiring hemodialysis, treated with elranatamab as a second line treatment following progression after therapy with daratumumab, bortezomib, lenalidomide, and dexamethasone. Despite experiencing grade I cytokine release syndrome during the initial administrations, symptoms were managed effectively with tocilizumab and dexamethasone, allowing treatment continuation...According to the literature, BCMA-directed immunotherapies, including teclistamab, belantamab mafodotin, and idecabtagene vicleucel, have shown efficacy in dialysis-dependent RRMM patients, though data remain limited...By providing real-world evidence for the use of bispecific antibodies in end stage renal disease patients, this review emphasizes the potential for expanding therapeutic options to this vulnerable population while highlighting the need for vigilant monitoring of infection..."

Journal • Chronic Kidney Disease • Hematological Malignancies • Infectious Disease • Inflammation • Multiple Myeloma • Nephrology • Oncology • Renal Disease

Multiple Myeloma Unpacked (ICML 2025) - P3 | "Several other phase II studies have explored the efficacy of triplet regimens incorporating Rd as a backbone, combined with agents such as elotuzumab [30], ixazomib [31], or carfilzomib [32] as well as quadruplet regimen including daratumumab and carfilzomib [33]...The landscape of induction treatment has evolved with the incorporation of the anti-CD38 monoclonal antibody daratumumab (D) into the triplet bortezomib-thalidomide-dexamethasone (VTd) and, more recently, bortezomib-lenalidomide-dexamethasone (VRd)...In transplant-ineligible patients, VRd [45], daratumumab-lenalidomide-dexamethasone (DRd) [46, 47] and daratumumab-bortezomib-melphalan-prednisone (DVMP) [48, 49] have been the standards of cares for years...The FDA approval of isatuximab-bortezomib-lenalidomide-dexamethasone (Isa-VRd), based on the results of the IMROZ study [38], which demonstrated the superiority of Isa-VRd over VRd in terms of MRD negativity and PFS, introduces a new SoC...Consequently,..."

IO biomarker • Hematological Malignancies • Multiple Myeloma • Oncology • Plasmacytoma • Smoldering Multiple Myeloma • B2M • CRBN • CTCs • XPO1

Comparative Efficacy and Safety of BCMA-Targeted CAR T-Cell Therapies and Bispecific Antibodies in Relapsed/Refractory Multiple Myeloma: A Comprehensive Review of Clinical Outcomes and Adverse Events (SOHO 2025) - " The monoclonal anti-CD38 antibodies daratumumab and isatuximab, when added to standard regimens, achieved ORRs of 60– 90%, median PFS of 11-22 months, and CR rates up to 40%, with infusion reactions (15-50%), neutropenia (20-40%), and infections representing the most common adverse events. The anti-BCMA ADC belantamab mafodotin yielded an ORR of approximately 32% in heavily pretreated cohorts, with a median DOR of 11 months, although ocular keratopathy (>60%) and thrombocytopenia (35– 45%) necessitated rigorous monitoring. BCMA × CD3 BiTEs such as teclistamab demonstrated ORRs of 60-65% and CR rates of 20– 30%, with cytokine release syndrome in 55-70% (predominantly grade 1-2), alongside frequent neutropenia (70%) and hypogammaglobulinemia. Targeted immunotherapies have shown strong response rates and lasting remissions in patients with relapsed or refractory multiple myeloma; however, their unique benefits and side effects highlight the need for personalized..."

Adverse events • CAR T-Cell Therapy • Clinical • Clinical data • Review • Hematological Malignancies • Multiple Myeloma • Oncology

A Post-Marketing Analysis of Gastrointestinal Adverse Events Following Chimeric Antigen Receptor T-Cell Therapy Using the FDA Adverse Event Reporting System (ACG 2025) - "Individual case safety reports listing any CAR-T therapies—Tisagenlecleucel (tisacel), Axicabtagene Ciloleucel (axicel), Lisocabtagene Maraleucel (lisocel), Brexucabtagene Autoleucel (brexucel), Idecabtagene Vicleucel (idecel), and Ciltacabtagene Autoleucel (ciltacel)—as the suspected drug for GI AEs were included. There were 1395 GI AEs with CAR-T reported in FAERS (Table 1). Compared to other CAR-T, Ciltacel was associated with immune effector-cell mediated enterocolitis (IEC-EC) and non-immune colitis; Lisocel with GI ulceration, necrosis, and cholestasis; Idecel with functional/motility disorders; and Axicel and Tisacel with GI bleed. Tisacel was also associated with abnormal liver function tests, pancreatitis, and functional/motility disorders.Distinct patterns were observed based on primary cancer."

Adverse events • CAR T-Cell Therapy • P4 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • B Cell Lymphoma • Cholestasis • Diffuse Large B Cell Lymphoma • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • Hematological Malignancies • Hepatology • Immunology • Large B Cell Lymphoma • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Pancreatitis • Primary Mediastinal Large B-Cell Lymphoma

The Evolving Landscape of Multiple Myeloma Mortality: A 20-Year US Population-Based Analysis (SOHO 2025) - "Introduction: The horizon of multiple myeloma (MM) has witnessed remarkable therapeutic advances, like the introduction of proteosome inhibitors and CAR-T therapy, in the past two decades. This US population-based analysis reveals two main findings. First, the annual reduction in mortality from 1999 to 2008 reflects the cumulative impact of improved supportive care, high-dose chemotherapy, and autologous stem cell transplantation. The introduction of proteasome inhibitors (bortezomib) and immunomodulatory drugs (lenalidomide) in the late 2000s was expected to accelerate mortality declines."

Clinical • Hematological Malignancies • Multiple Myeloma • Oncology

Cardiovascular Adverse Events Among Cancer Patients Receiving Chimeric Antigen Receptor T-Cell Therapy (SOHO 2025) - "Adult patients (≥18 years) who received one of the six FDA-approved CAR-T products (tisagenlecleucel, axicabtagene, brexucabtagene, lisocabtagene, idecabtagene, or ciltacabtagene) between years 2017-2024 were included, using relevant procedure codes. CAEs were observed in about 26% of CAR-T recipients within 3 months, with hypotension being the most common manifestation. Importantly, up to 6% of patients developed heart failure. These findings highlight the need for heightened cardiovascular monitoring, especially because hypotension may not always be attributable to CRS alone."

Adverse events • CAR T-Cell Therapy • Clinical • Diffuse Large B Cell Lymphoma • Oncology

Low Occurrence of Ocular Adverse Events after CAR-T Cell Therapy. (PubMed, Ocul Oncol Pathol) - "Billing codes were used to identify patients receiving autologous CAR-T therapy approved by the US Food and Drug Administration (FDA) for the treatment of a hematological malignancy: tisagenlecleucel, brexucabtagene autoleucel, lisocabtagene maraleucel, ciltacabtagene autoleucel, idecabtagene vicleucel, or axicabtagene ciloleucel. In the period of 6 months following CAR-T therapy infusion, o-AEs were rare in patients receiving CAR-T cell therapy, indicating that patients without existing eye conditions do not need routine prescreening or directed follow-up after treatment, unless symptomatic. Ongoing monitoring and reporting of ocular adverse events will be important given the durable effects of CAR-T therapy in the treatment of hematologic cancers as well as increasing indications for CAR-T therapy in malignant and nonmalignant disease."

Adverse events • Journal • Conjunctivitis • Dry Eye Disease • Hematological Disorders • Hematological Malignancies • Herpes Zoster • Keratitis • Leukemia • Lymphoma • Ocular Infections • Ocular Inflammation • Oncology • Ophthalmology • Optic Neuritis • Uveitis

Post-marketing Safety Assessment of CAR T-cell Therapies: Analysis of Individual Case Safety Reports in the VigiBase. (PubMed, Ther Innov Regul Sci) - "Our study provides an overall exploration of the post-marketing safety profiles of currently approved CAR-T cell therapies. The significant proportion of fatalities occurred in accordance with approved indications, emphasizes the need for ongoing investigation into ADRs with fatal outcomes, particularly in the pediatric population."

Journal • P4 data • Hematological Disorders • Hematological Malignancies • Oncology • Pediatrics

Neighborhood Socioeconomic Disadvantage and Distance From Treatment Center Do Not Impact Survival Outcomes of Patients With non-Hodgkin Lymphoma and Multiple Myeloma Treated With CAR T-Cell Therapies (SOHO 2025) - "CAR T-cell products used included axi-cel, tisa-cel, liso-cel, brexu-cel (B-NHL) and ide-cel and cilta-cel (MM). In this single-center study, neighborhood disadvantage and DTC did not impact response or survival outcomes in patients with access to CAR T-cell therapies. However, patients from more disadvantaged neighborhoods had to travel farther. These findings highlight access disparities and support broader, multicenter studies to assess their impact on CAR-T delivery and outcomes."

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

Knowledge-map and bibliometric analysis of scientific research on FDA-approved Chimeric Antigen Receptor T cell products (2015-2024). (PubMed, Discov Oncol) - "This study offers a translationally relevant perspective for clinicians, researchers, and policymakers, and underscores the evolving priorities in therapeutic development, access, and sustainability in precision oncology."

FDA event • Journal • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology

Characterizing the Real-World Risks of Kidney Injuries Associated with Chimeric Antigen Receptor T Cell Therapies-Evidence and Safety. (PubMed, Health Data Sci) - " Six therapies were evaluated involving a total of 9,770 patients, with only acute kidney injury (AKI) identified as associated with idecabtagene vicleucel treatment using 4 algorithmic thresholds, including disproportionality analysis... CAR-T therapies do not directly cause renal damage and necessitate controlling adverse renal risks during or after treatment, such as cytokine release syndrome. Future research efforts should rigorously optimize these aspects to better cater to nephrologists' requirements."

Journal • Real-world evidence • Acute Kidney Injury • Inflammation • Nephrology • Renal Disease

Early Free Light-Chain Suppression as a Prognostic Marker in Relapsed and Refractory Myeloma Patients Treated With BCMA-Directed CAR-T Cells. (PubMed, EJHaem) - "B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T-cell (CAR-T) therapies, such as idecabtagene vicleucel (ide-cel) and ciltacabtagene autoleucel (cilta-cel), have improved outcomes, yet many patients relapse within a year. Prospective validation is warranted to integrate FLC suppression into early response assessment strategies. The authors have confirmed clinical trial registration is not needed for this submission."

Biomarker • IO biomarker • Journal • Hematological Malignancies • Multiple Myeloma • Oncology

Idecabtagene vicleucel (ide-cel) and endogenous immune profiles linked to progression-free survival in relapsed/refractory multiple myeloma (RRMM) patients (IMS 2025) - No abstract available

Clinical • Hematological Malignancies • Multiple Myeloma

Optimizing Selection of Bridging Therapies Prior to CAR-T Therapy Administration for Multiple Myeloma: Clinical Pearls From an Expert Roundtable. (PubMed, Clin Lymphoma Myeloma Leuk) - "This review aims to provide an overview of key considerations influencing bridging therapy selection and to outline practical guidance for selection of bridging therapy across patient populations. With expanded indications and earlier referrals for patients to receive CAR-T therapy for MM, continued collaboration with experienced CAR-T providers will be instrumental in optimizing administration of bridging therapy and improving overall patient outcomes."

Journal • Hematological Malignancies • Multiple Myeloma • Oncology

Efficacy and Safety of Idecabtagene Vicleucel in Relapsed/Refractory Multiple Myeloma: A Meta-Analysis (SOHO 2025) - "Ide-cel demonstrates significant clinical activity in RRMM, with a notable complete response rate and a rapid median time to initial response. Additional large-scale clinical trials comparing ide-cel with the conventional therapies in RRMM are recommended to support the findings."

Retrospective data • Hematological Malignancies • Multiple Myeloma • Oncology

Safety and Efficacy of BCMA directed Chimeric Antigen Receptor T-Cell Therapy for the Treatment of Plasma Cell Leukemia. (PubMed, Blood Adv) - "Rates of hematological and non-hematological toxicities were similar between those patients treated with cilta-cel and ide-cel and consistent with those reported in patients with MM. In this first multicenter study evaluating patients with PCL treated with standard of care CAR-T products, we show that CAR-T is safe, feasible, and associated with improved outcomes compared to historical standards."

Clinical • Journal • Hematological Malignancies • Multiple Myeloma • Plasma Cell Leukemia

Farorable outcome of Relapsed/Refractory Multiple Myeloma treated with Idecabtagene Vicleucel (Ide-cel) Chimeric Antigen Receptor (CAR) T-Cell Therapy; IFM experience from the Descar-T Registry (IMS 2025) - No abstract available

Late-breaking abstract • Hematological Malignancies • Multiple Myeloma

Pre-infusion ferritin a predictive biomarker for CAR T-cell therapy in R/R multiple myeloma (Frontiers) - "Low ferritin levels at Day-0 and 88 pre-LDC were able to predict better responses regardless of the CAR T cell 89 product (hazard ratio [HR] 0.01 (95% CI 0.05–0.5); p=0.001, (HR 0.05 95% CI 90 0.01-0.2, p=<0.0069), respectively. Low ferritin + low CRP were able to predict responses at Day-0 and pre-LDC HR 0.3 (95% CI 0.07-1.3); p=0.04, HR 0.26 (95% CI 0.03-2.1), p=0.04, respectively."

Biomarker • Retrospective data • Multiple Myeloma

The Efficacy and Safety of Cilta-Cel and Ide-Cel in Relapsed/Refractory Multiple Myeloma: A Meta-Analysis (SOHO 2025) - "Both ide-cel and ciltacel are effective in RRMM, with cilta-cel demonstrating superior efficacy and MRD-negativity but greater hematologic toxicity. Ide-cel shows a more favorable safety profile. Treatment selection should weigh efficacy against toxicity; further direct comparisons are warranted."

Retrospective data • Hematological Malignancies • Multiple Myeloma • Oncology

Characteristics and Real-World Outcomes Following CAR T-Cell Therapy in Relapsed Multiple Myeloma: A Multi-Institutional US Descriptive Study (SOHO 2025) - "Patients with relapsed MM who had received one of the FDA-approved CAR-T treatments, idecabtagene vicleucel or ciltacabtagene autoleucel, were eligible. These findings emphasize the importance of proactive toxicity management strategies and adequate healthcare resource planning to support the growing use of CAR T-cell therapy in MM in real-world settings. Further research is needed to identify predictors of high healthcare utilization and to assess the long-term impact on healthcare costs and survival rates."

CAR T-Cell Therapy • Clinical • Real-world • Real-world evidence • Hematological Malignancies • Multiple Myeloma • Oncology

Managing the Aftermath: Hospital Trajectories and Readmission Patterns Following BCMA-Directed CAR-T Therapy (SOHO 2025) - "Background: Idecabtagene vicleucel [ide-cel] and ciltacabtagene autoleucel [cilta-cel] are B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T-cell therapies used in relapsed/ refractory multiple myeloma (RRMM). These findings highlight the substantial healthcare burden resulting from BCMA CAR-T therapy. Therefore, post-discharge monitoring and prompt and effective interventions in high-risk subgroups are needed to reduce early hospital readmissions."

Clinical • Hematological Malignancies • Multiple Myeloma • Oncology

Efficacy of idecabtagene vicleucel in patients with relapsed/refractory multiple myeloma and prior central nervous system manifestation: A multicenter real-world analysis. (PubMed, Hemasphere) - No abstract available

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

Comparative Meta-Analysis of Anti-B-Cell Maturation Antigen Therapies in Relapsed/ Refractory Multiple Myeloma: Teclistamab, Ciltacabtagene Autoleucel, and Idecabtagene Vicleucel (SOHO 2025) - "Cilta-cel demonstrated the highest response among the three agents, albeit with high toxicity. Ide-cel also showed robust efficacy almost similar to that of cilta-cel. Teclistamab, while exhibiting a lower ORR, may offer a viable alternative for patients ineligible for CAR-T therapy."

Retrospective data • Hematological Malignancies • Multiple Myeloma • Oncology