Tecartus (brexucabtagene autoleucel) / Gilead, Fosun Kite - LARVOL DELTA

Study of Brexucabtagene Autoleucel Plus Dasatinib in Adults With Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1 | N=8 | Active, not recruiting | Sponsor: Stanford University | Recruiting ➔ Active, not recruiting | N=20 ➔ 8 | Trial completion date: Aug 2025 ➔ Jun 2027 | Trial primary completion date: Aug 2025 ➔ Jun 2027

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD19

Today, Fosun Pharma's subsidiary's CAR-T product was submitted for listing. [Google translation] (163.com) - "Based on the drug's clinical trial progress, the Insight database speculates that the application may be for adult patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia."

China filing • B Acute Lymphoblastic Leukemia

Therapy Sequencing in Relapsed/Refractory MCL (ICML 2025) - P1, P1/2, P2, P3 | "Although a direct comparison between them has only been performed for ibrutinib and temsirolimus [23], covalent BTK inhibitor (cBTKi) single agent therapy has been consolidated as the standard of care after first-line CIT. Moreover, to address cBTKi failure, two anti-CD19 CAR-T cell therapy products, brexucabtagene autoleucel [20, 21] and lisocabtagene maraleucel [22], and the first noncovalent BTKi, pirtobrutinib [19], have recently been approved...Liso-cel only FDA approved; CIT, chemoimmunotherapy options include BR, R-BAC, R-CHOP, R-DHAP or R-DHAOx, R-GEMOx, paliative options (avoid bendamustine pre-CART apheresis); pirtobrutinib, available after cBTKi failure in second-line (EMA) but third-line (FDA); RM, rituximab maintenance...Orelabrutinib [18] is licensed only in China...Of note, both acalabrutinib and zanubrutinib induce lower rates of atrial fibrillation, hypertension, and bleeding compared to ibrutinib in randomized studies..."

IO biomarker • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Oncology • PLCG2 • TP53

High-Risk MCL: Definition and Innovative Treatment Strategies (SOHO 2025) - "Pirtobrutinib, a non-covalent BTKi, demonstrates activity in patients with prior BTKi exposure, though less effective in this population compared to BTKi-naïve patients with complete response [CR] rates of 20% vs 35%, respectively...Glofitamab, a CD20 × CD3 BITE, appears more promising in patients with prior BTKi exposure, eliciting CR rates of 71%, a median duration of CR of 12.6 months, and median PFS of 8.6 months...ZUMA-2 evaluated brexucabtagene autoleucel in R/R high-risk MCL, while the TRANSCEND MCL cohort evaluated lisocabtagene maraleucel in a similar population of R/R MCL but also allowed for more prior lines of therapy and secondary central nervous system (CNS) disease (8% of patients)...Selected upfront chemotherapy-free trials for high-risk MCL patients Trial Regimen Outcome in overall population Outcomes in TP53- mutated or aberrant MCL Outcomes in other high-risk MCL TP53 mutations = 15% pts mPFS 39 mo High MIPI = 38% Outcomes inferior to overall..."

IO biomarker • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Lymphoma • Mantle Cell Lymphoma • Oncology • KMT2D • NOTCH1 • NOTCH2 • ROR1 • SMARCA4

Safety, Efficacy, and Length-of-Stay Analysis of Outpatient CAR-T Therapy in Non-Hodgkin Lymphoma Patients at a Community-Based Medical Center (SOHO 2025) - "Objectives: Assess the safety, tolerability, and outcomes of outpatient CAR-T therapy for non-Hodgkin lymphoma patients treated with axicabtagene ciloleucel (axi-cel), lisocabtagene maraleucel (liso-cel), tisagenlecleucel (tisa-cel), or brexucabtagene autoleucel (brexu-cel) in a community setting...None received prophylactic dexamethasone or tocilizumab... Outpatient CAR-T therapy is feasible with comparable safety, efficacy, and improved cost effectiveness based on lower length of hospital stay. Larger prospective studies are warranted."

Clinical • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Nodal Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

CARing for ALL: A Multicenter Real-World Study of ALL Patients Treated with CAR T-cell Therapy Using the TriNetX Database (SOHO 2025) - "Tisagenlecleucel and brexucabtagene autoleucel are both anti-CD19 CAR T-cell therapies...In the adult group, 45% of patients required tocilizumab for complications, 39.2% patients received it in the pediatric group... ALL patients being administered CAR T-cell therapy experience a significant number of adverse effects, 2 of 5 patients develop CRS; almost 1 of 5 adult patients develop ICANS. Mortality among the adult and pediatric groups was noted to be similar at 30%; historically, outcomes for adult ALL patients have been worse as compared to their pediatric counterparts. Adult patients have a higher prevalence of comorbidities."

CAR T-Cell Therapy • Clinical • Real-world • Real-world evidence • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Brexucabtagene Autoleucel (Brexu-Cel) as Consolidation Treatment in Adults With B-Cell Acute Lymphoblastic Leukemia (B-ALL): Efficacy and Toxicity in a Real-World Setting (SOHO 2025) - "The median number of prior therapies (including blinatumomab [98%], inotuzumab [77%], allo-SCT [15%]) was 2 (range, 1-8); 10 patients received CAR-T in CR1...Twenty-two (42%) and 13 (25%) received tocilizumab and dexamethasone, respectively... Brexu-cel as a consolidation strategy demonstrates CART expansion even in patients with no morphologic disease. A ≥15-cells/μL expansion threshold predicts durable RFS and demonstrates low rates of G3-4 CRS/ICANS."

Clinical • Real-world • Real-world evidence • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

A Pilot "Window-3" Study of Acalabrutinib Plus Rituximab Followed by Brexucabtagene Autoleucel Therapy in Patients With Previously Untreated High-risk Mantle Cell Lymphoma (clinicaltrials.gov) - P1 | N=22 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Recruiting ➔ Active, not recruiting

Enrollment closed • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology • BIRC3 • CCND1 • CD20 • FAT1 • KMT2D • NOTCH2 • NSD2 • POT1 • TP53 • UBR5

Unmasking Hodgkin-Like Features in Mantle Cell Lymphoma After CAR-T Therapy: A Case of Composite Lymphoma (SOHO 2025) - "Based on tumor board discussion, he was initiated on Nordic-type R-CHOP/DHAP induction followed by CAR-T therapy of brexucabtagene autoleucel (Tecartus) after standard fludarabine and cyclophosphamide (Flu/Cy) conditioning...Brentuximab was later discontinued due to neutropenia; he continued on single-agent nivolumab... Composite lymphomas involving MCL pose unique diagnostic and therapeutic challenges. CAR-T therapy can play a significant role in the treatment of composite lymphoma; studies are needed to evaluate its efficacy. Multimodal management and vigilant surveillance are essential in addressing these complex post-CAR-T evolutions."

Clinical • Chronic Lymphocytic Leukemia • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Mantle Cell Lymphoma • Oncology • CCND1 • CD5 • FCER2 • TNFRSF8

A Post-Marketing Analysis of Autoimmune Toxicities Following Chimeric Antigen Receptor T-Cell Therapy Using the FDA Adverse Event Reporting System (ACR Convergence 2025) - "All individual case safety reports listing any of the 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 were included. This post-marketing pharmacovigilance analysis highlights product- and disease-specific patterns of autoimmune AEs following CAR-T therapy. While limited by FAERS reporting bias, these findings support the need for monitoring strategies and emphasize the importance of prospective studies to validate these associations. Integrating pharmacogenomic and immunologic correlates may further elucidate underlying mechanisms."

Adverse events • CAR T-Cell Therapy • IO biomarker • P4 data • B Acute Lymphoblastic Leukemia • B Cell Lymphoma • Complement-mediated Rare Disorders • Follicular Lymphoma • Gastrointestinal Disorder • Hematological Malignancies • Immunology • Indolent Lymphoma • Inflammatory Arthritis • Leukemia • Lupus • Lymphoma • Musculoskeletal Diseases • Myositis • Non-Hodgkin’s Lymphoma • Ocular Inflammation • Ophthalmology • Optic Neuritis • Rheumatology • Sarcoidosis • Vasculitis • ROR1

CAR-T Cell Therapy in RR B-ALL (ICBMT 2025) - "So far, three products representing autologous CAR T-cells with anti-CD19 specificity, tisagenlecleucel (tisa-cel), brexucabtagene autoleucel (brexucel) and obecabtagene autoleucel (obe-cel) have been approved for the treatment of relapsed/refractory (RR) B-ALL...Similarly, allogeneic CAR T-cells are being engineered, with the objective to simplify the logistics of the procedure. Taking into account its very high research and development potential, it can be hypothesized that, in the future, CAR T-cells will become an important component of the treatment algorithm, not necessarily restricted to RR setting, but used already in first line treatment."

CAR T-Cell Therapy • IO biomarker • CD22

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

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

Glycemic Outcomes Following CAR T-Cell Therapy: A Real-World Multicenter Analysis of Hemoglobin A1c Trends (SOHO 2025) - "CAR T-cell agents included axicabtagene ciloleucel, tisagenlecleucel, lisocabtagene maraleucel, brexucabtagene autoleucel, and ciltacabta-gene autoleucel. This real-world analysis suggests that approximately 1 in 10 patients may develop elevated HbA1c following CAR T-cell therapy, raising concern for treatment-associated glycemic disturbances. The observed patterns— particularly among younger and racially diverse subgroups— highlight the need for further investigation. While causality cannot be established from retrospective data alone, these findings underscore the importance of post-CAR T-cell therapy metabolic monitoring and support prospective studies to define risk factors and long-term outcomes."

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

Characteristics and Health Care Utilization in Relapsed Patients With Acute Lymphoblastic Leukemia Receiving CAR-T Therapy: A Real-World Study (SOHO 2025) - "Key eligibility criteria included patients with the diagnosis of relapsed ALL and who received an FDA-approved CAR-T treatment for ALL (tisagenlecleucel, brexucabtagene autoleucel). These findings highlight the need for proactive toxicity management strategies and adequate health care resource planning to support the expanding use of CAR-T therapy in ALL in real-world settings. Further studies are warranted to identify predictors of high health care utilization and evaluate the long-term impact on health care costs and survival outcomes."

Clinical • HEOR • Real-world • Real-world evidence • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

An Economic Model Comparing the Costs Associated with Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) Among Patients Treated with Chimeric Antigen Receptor (CAR) T-Cell Therapies for Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (R/R B-ALL) (SOHO 2025) - P1/2 | "Objective: To estimate the cost of CRS/ICANS in patients with R/R BALL treated with obe-cel or brexucabtagene autoleucel (brexu-cel)... Obe-cel was associated with lower CRS/ICANS-related healthcare costs versus brexu-cel. These results suggest that obe-cel improves resource utilization and reduces healthcare costs versus other CAR T-cell therapies for R/R B-ALL. Funding: Autolus."

Clinical • Cytokine release syndrome • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

The impact of social determinants of health on outcomes of brexucabtagene autoleucel in adults with relapsed/refractory B-cell acute lymphoblastic leukemia. (PubMed, Bone Marrow Transplant) - "Outcomes appear independent of SDoH and SDoH did not impact OS. We observed comparable outcomes to non-Hispanic patients."

Journal • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

Outpatient Brexucabtagene Autoleucel in B-Cell Acute Lymphoblastic Leukemia and Mantle Cell Lymphoma. (PubMed, Am J Hematol) - No abstract available

Journal • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Oncology • T Acute Lymphoblastic Leukemia

Gilead Sciences Announces Second Quarter 2025 Financial Results (Businesswire) - "Cell Therapy product sales decreased 7% to $485 million in the second quarter 2025 compared to the same period in 2024, reflecting ongoing competitive headwinds. (i) Yescarta (axicabtagene ciloleucel) sales decreased 5% to $393 million in the second quarter 2025 compared to the same period in 2024, primarily driven by lower demand, partially offset by higher average realized price; (ii) Tecartus (brexucabtagene autoleucel) sales decreased 14% to $92 million in the second quarter 2025 compared to the same period in 2024, primarily reflecting lower demand, partially offset by higher average realized price."

Sales • Acute Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Mantle Cell Lymphoma

CAR T cell therapy in acute lymphoblastic leukemia (PubMed, Inn Med (Heidelb)) - "Modern immunotherapy in the form of T‑cell-based CD19-targeted approaches, such as the approved bispecific T‑cell engager (BiTE antibody) blinatumomab and chimeric antigen receptor T cells (CAR T cells) with the approved products tisagenlecleucel and brexucabtagene autoleucel has revolutionized the treatment of B‑precursor acute lymphoblastic leukemia (ALL). Furthermore, resistance mechanisms are discussed and an outlook on further development is given. The T‑precursor ALL remains a challenge due to its immunological complexity but new developments in CAR-T cell treatment approaches targeting CD5 and CD7 show that progress is also being made in this area."

Journal • Review • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia • CD5 • CD7

Real-world outcomes of brexucabtagene autoleucel for relapsed or refractory mantle cell lymphoma: a CIBMTR analysis. (PubMed, Blood Adv) - "Here, we report real-world effectiveness and safety outcomes of brexu-cel in a prospective study of patients with r/r MCL, including subgroups based on prior treatment with Bruton's tyrosine kinase inhibitor, bendamustine, or autologous hematopoietic cell transplant (auto-HCT) and number of prior therapy lines, using Center for International Blood and Marrow Transplant Research registry data. In patients with 1-2 prior therapy lines, relapse or progression was less frequent compared with those with 3 or more prior lines (HR 0.64; 95% CI, 0.42-1.00). Collectively, our results suggest that real-world outcomes with brexu-cel were consistent with ZUMA-2, regardless of prior therapy type or number of prior therapy lines."

Journal • Real-world evidence • Hematological Disorders • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology • Thrombocytopenia • Transplantation

(Cohort 3) ZUMA-2: Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 3) (clinicaltrials.gov) - P2 | N=95 | Completed | Sponsor: Kite, A Gilead Company | Active, not recruiting ➔ Completed

Trial completion • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology

JKART-1: Study of KTE-X19 in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P2 | N=25 | Active, not recruiting | Sponsor: Kite, A Gilead Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Oncology