Yescarta (axicabtagene ciloleucel) / Cabaret Biotech, National Cancer Institute, Gilead, Fosun Kite - LARVOL DELTA

CAR T-Cell Therapy Use in Rare Lymphoid Malignancies: A Single-Center Experience (SOHO 2025) - "He received Axi-Cel, with a course complicated by grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS) and grade 1 cytokine release syndrome (CRS), requiring steroids, tocilizumab, and anakinra...Case 3: A 62-year-old male with isolated CNS relapse of DLBCL received Axi-Cel after failing methotrexate (MTX)-based treatment... This report adds evidence supporting CAR-T therapy in challenging conditions like PTLD and CNSL, where larger clinical trials are ongoing or difficult to conduct."

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

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

Relapsed/Refractory Indolent Lymphoma: Options Beyond Immunotherapy (SOHO 2025) - "Third-line immunotherapy-based strategies are now approved for the treatment of patients with multiple relapses, including the chimeric antigen receptor T-cell (CAR-T) constructs axicabtagene ciloleucel, tisagenlecleucel, and lisocabtagene maraleucel, as well as bispecific antibodies like the anti-CD20 × CD3 agents mosunetuzumab and epcoritamab...Obinutuzumab was chosen as the companion of zanubrutinib due to the high proportion of rituximab-refractory patients enrolled in the study and was administered in both arms up to 20 infusions...Loncastuximab with Rituximab In a population of 39 advanced-stage FL patients, including 20 cases of disease relapse within 24 months since frontline treatment (POD24), the combination of the two drugs in an outpatient fixed-duration regimen produced a complete response rate of 67% after 12 weeks on-therapy, which rose to 77% within 21 weeks...Compared with existing agents targeting Ikaros/Aiolos, such as lenalidomide, avadomide, and..."

B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CRBN • IKZF1

Pembrolizumab Monotherapy Achieves Sustained Complete Metabolic Remission in Mediastinal B-Cell Lymphoma Relapsing After CD19-Directed CAR T-Cell Therapy: A Case Report (SOHO 2025) - "Case Description: A 48-year-old man was diagnosed in May 2021 with primary mediastinal B-cell lymphoma that proved refractory to first-line R-CHOP and second-line R-DHAOX...In January 2022, he received CD19-targeted chimeric antigen receptor (CAR) T-cell therapy (axicabtagene ciloleucel)... This case illustrates that checkpoint inhibition with pembrolizumab can rescue patients with relapsed or refractory primary mediastinal B-cell lymphoma after CAR T-cell therapy, even in the absence of tissue confirmation. This case highlights the value of immune modulation as a bridge to long-term disease control and underscores the importance of personalized, multidisciplinary decision-making when standard salvage options are limited."

CAR T-Cell Therapy • Case report • Clinical • Monotherapy • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Mediastinal B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma

Best of Cell Therapy for Lymphoma: What We Learned in 2024 and 2025 (SOHO 2025) - P1/2, P2 | "Autologous CAR-T Therapy CD19 CAR-T New Regulatory Approvals In March 2024, the United States Food and Drug Administration (FDA) granted accelerated approval to lisocabtagene maraleucel (lisocel) for relapsed/refractory (R/R) chronic lymphocytic leukemia/ small lymphocytic lymphoma (CLL/SLL) after Bruton tyrosine kinase inhibitors (BTKis) and B-cell lymphoma 2 (BCL2) inhibitors, making it the first CAR-T approval in this disease...Long-Term Follow-up of Pivotal CD19 CAR-T Trials TRIAL (PRODUCT) LYMPHOMA SUBTYPE MEDIAN FU (MONTHS) ORR (%) CR (%) MEDIAN PFS (MONTHS) PFS (%) OS (%) NOTABLE SAFETY FINDINGS 64.6 90 75 (79% in FL cohort, 65% in MZL cohort) 62.2 53 (5 yr) 69 (5 yr) No new late signals ZUMA-5 (AXICEL) FL/MZL ( ≥ 3L) ELARA (TISA-CEL) FL ( ≥ 3L) 53 – * 69.1 53.3 50.2 (4 yr) 79.3 (4 yr) No new late signals; 6.2% secondary primary malignancies TRANSCEND FL (LISO-CEL) FL (2L+ high-risk/3L+) 29.5 – 30 95.7 – 97.1 94.2 – 95.7 NR 72.5 – 82.6 (2 yr) 88.2 –..."

IO biomarker • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Chronic Lymphocytic Leukemia • Follicular Lymphoma • Hodgkin Lymphoma • Indolent Lymphoma • Large B Cell Lymphoma • Leukemia • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Oncology • Peripheral T-cell Lymphoma • Small Lymphocytic Lymphoma • T Cell Non-Hodgkin Lymphoma • CD22 • CD5 • IL15 • TNFRSF8

CAR-T Cell Therapy in B-Cell Lymphoma (ICBMT 2025) - P3 | "This treatment approach was first available in the third or later line setting (3L+) based on the results of single -arm trials, namely ZUMA -1 (axicabtagene ciloleucel [axi -cel]), JULIET (tisagenlecleucel [tisa -cel]) and TRANSCEND -NHL -001 (lisocabtagene maracelucel [liso -cel]1-3...Three main issues should be taken into account when planning treatment for a potential CART candidate: 1) Confirming an adequate washout of prior systemic treatment at time of leukapheresis, including at least 2 weeks in case of chemotherapy and 6 -12 months for bendamustine 15,47; 2) CD20/CD3 -targeted BsAbs seem safe prior to leukapheresis, if a sufficient time interval is maintained 48, but data in the bridging period are lacking; 3) CD19 -directed agents such as tafasitamab 49,50 or loncastuximab tesirine 51-53 could potentially decrease target expression and subsequent CAR T -cell efficacy 54,55, but further studies are warranted to better understand their individual..."

CAR T-Cell Therapy • IO biomarker • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Indolent Lymphoma • Infectious Disease • Large B Cell Lymphoma • Leukemia • Lymphoma • Mediastinal B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Primary Mediastinal Large B-Cell Lymphoma • BCL2 • BCL6

Management of Mantle Cell Lymphoma in Patients Previously Treated with Covalent BTK Inhibitors (SOHO 2025) - "Noncovalent BTKis Noncovalent BTKis, such as pirtobrutinib, offer a promising option in the post-covalent BTKi setting, with clinically meaningful activity...8,9 Among available CAR T-cell therapies in this setting, axicabtagene ciloleucel (axi-cel) has demonstrated excellent long-term outcomes, while lisocabtagene maraleucel (liso-cel) — although with shorter available follow-up data — demonstrates lower rates of high-grade CAR T-cell therapy-related toxicities, including cytokine release syndrome (CRS) and immune effector-associated neurotoxicity syndrome (ICANS)...Bispecific antibodies, such as glofitimab and mosunetuzumab, have demonstrated promising activity in clinical trials, either alone or in combination with other agents, including the antibody-drug conjugate polatuzumab vedotin...However, CRS remains a potential issue with the use of bispecifics in MCL, although step-up dosing and the use of obinutuzumab pretreatment have been associated with reduced..."

Clinical • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CCND1 • CD20

Going Beyond Conventional CAR T Cell Therapies for Treatment of Blood Cancer and Other Diseases (ICBMT 2025) - "The clinical success of first -generation CAR T cell therapies —such as tisagenlecleucel and axicabtagene ciloleucel —has transformed treatment paradigms for hematologic malignancies. This success was built on three core foundations: (1) ideal target antigens such as CD19 and BCMA with restricted expression profiles, (2) incorporation of costimulatory domains like CD28 and 4 -1BB to enhance expansion and persistence, and (3) effective mitigation strategies for toxicities including cytokine release syndrome (CRS ) and neurotoxicity, notably with tocilizumab and corticosteroids...Modular platforms enable post -infusion redirection and re -arming of CAR T cells, offering greater flexibility and control. In summary, next -generation CAR therapies are rapidly expanding beyond hematologic malignancies into solid tumors and allogeneic formats, with novel engineering and manufacturing solutions poised to improve scalability, safety, and accessibility."

CAR T-Cell Therapy • IO biomarker • Graft versus Host Disease • Hematological Malignancies • Oncology • Solid Tumor

Comparative Effectiveness and Safety of Salvage Chemotherapy Regimens Versus Chimeric Antigen Receptor T-Cell Therapies in Relapsed/Refractory Diffuse Large B-Cell Lymphoma: A Bayesian Network Meta-Analysis (SOHO 2025) - "While many patients are cured with R-CHOP, a substantial number relapse or develop refractory disease, particularly after second-line treatment failure or ineligibility for autologous stem cell transplantation. CD19-directed CAR-T therapies offer superior clinical benefit compared with salvage chemotherapy in R/R DLBCL. Axi-cel provides strong disease control with higher toxicity, while tisa-cel and liso-cel offer more favorable safety profiles. These findings support CAR-T therapies as the preferred treatment in eligible patients and emphasize the need for personalized treatment strategies based on efficacy, toxicity, and patient factors."

CAR T-Cell Therapy • HEOR • Retrospective data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Impact of Obesity on Efficacy, Safety, and Expansion Kinetics of CAR-T Therapy in Relapsed or Refractory Large B-Cell Lymphoma (SOHO 2025) - "BMI does not significantly affect CAR-T therapy outcomes, despite weight-based dosing for axi-cel, suggesting its effectiveness for lymphoma patients regardless of BMI."

Clinical • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD4 • CD8

A Multi-Model Machine Learning Framework Identifies Resistance-Associated Biomarkers in Axicabtagene Ciloleucel CAR T-Cell Therapy for Large B-Cell Lymphoma (ASTRO 2025) - No abstract available

Biomarker • CAR T-Cell Therapy • Machine learning • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • 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

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

Large B-Cell Lymphoma Microenvironment Archetype Profiles (LymphoMAPs) Clinically Identify Subgroups With Greatest Benefit From CD19 CAR T-Cell Therapy (SOHO 2025) - "This was validated in the ZUMA7 trial (axi-cel in second-line LBCL), where LymphoMapR classification of Nanostring data showed that LN patients had the most favorable outcomes (HR = 0.2, P < 0.0001), with 1-year progression-free survival of 67% vs 43% and 35% in FMAC and TEX patients, respectively. Archetype did not influence outcomes in the chemotherapy arm. These results suggest that LymphoMAPs reflect key features of the LBCL microenvironment that shape therapy response and offer targets for future interventions."

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

Gilead plots Korea oncology push with Trodelvy, prepares Yescarta launch (Korea Biomedical Review) - "After dominating Korea’s virology market for more than a decade, Gilead Sciences is shifting gears, building out an oncology portfolio and preparing to file its first CAR-T therapy in the country. The pivot is anchored by Trodelvy (sacituzumab govitecan), the company’s only oncology drug currently on the Korean market....Next in line is Yescarta (axicabtagene ciloleucel), Gilead’s CAR-T therapy for relapsed or refractory large B-cell lymphoma, developed through Kite, its U.S.-based cell therapy subsidiary. Already designated an orphan drug in Korea, the company has completed its local regulatory filing and is aiming for a commercial launch in 2026."

Launch non-US • B Cell Lymphoma

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

Clinical representativeness of pivotal trials for T-cell engagers in relapsed/refractory follicular lymphoma. (PubMed, Future Oncol) - "The epcoritamab trial enrolled more broadly and was more representative of typical R/R FL patients than the mosunetuzumab, tisa-cel, and axi-cel trials. Differences in patient characteristics should be considered when evaluating the comparative benefits of T-cell engagers in R/R FL after ≥ 2 systemic therapies."

Journal • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

Clinical, Economic, and Humanistic Outcomes of First-Line High-Risk Large B-Cell Lymphoma: A Series of Systematic Literature Reviews (SOHO 2025) - "Older regimens, with robust long-term data highlight poor prognosis in double-expressor lymphoma and patients with DHL, while newer therapies, such as axi-cel (in trials) demonstrate potential for improved OS (12 m, 91%; 36 m, 81%) and progression-free survival (PFS; 12 m, 75%; 36 m, 75%). Novel combination regimens that incorporated additional agents, such as Pola-R-CHP + venetoclax and R-CHOP + azacitidine achieved higher response rates than standard therapies... Although available data indicate that approved treatments may be beneficial, the clinical burden in 1L high-risk LBCL remains considerable and has potential to impact costs. The literature underscores the need for more clinically effective treatments. Effective 1L therapies for high-risk LBCL could help reduce the need for subsequent treatments, ultimately improving patient outcomes while lowering overall healthcare costs."

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

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

Comparative real-world outcomes of CD19-directed CAR T-cell therapies in large B-cell lymphoma. (PubMed, Blood Adv) - "Axi-cel was associated with faster vein-to-vein time (axi-cel: 35 days, tisa-cel: 43 days, liso-cel: 41 days; p < 0.001) and fewer out-of-specification products (axi-cel: 2%, tisa-cel: 4%, liso-cel: 11%; p = 0.004). These results provide insights into potential differential outcomes depending on product selection."

Clinical • Journal • Real-world evidence • B Cell Lymphoma • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Large B Cell Lymphoma • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology

CD19 Directed CAR T Therapy for Transformed Follicular Lymphoma: A CIBMTR Analysis. (PubMed, Am J Hematol) - "Most patients (78%) received axicabtagene ciloleucel, with 67% of patients having resistant disease at the time of CAR T infusion...Older age ≥ 60 significantly increased the risk of NRM. Our study suggests that CD19 CAR T is effective and safe for tFL."

Journal • CNS Disorders • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology • Transplantation

Pharmacoeconomic Profiles of Advanced Therapy Medicinal Products in Rare Diseases: A Systematic Review. (PubMed, Healthcare (Basel)) - "ATMPs for rare blood diseases, such as tisagenlecleucel and axicabtagene ciloleucel, were found to be cost-effective in a majority of studies, with incremental QALYs ranging from 1.5 to 10 per patient over lifetime horizon...Onasemnogene abeparvovec for spinal muscular atrophy (SMA) showed uncertain cost-effectiveness results, and voretigene neparvovec for retinal diseases was not cost-effective in 40% of studies, with incremental QALYs around 1.3 and high costs exceeding the WTP threshold set. ATMPs in treating rare diseases show promising economic potential, but cost-effectiveness varies across indications. Policymakers must balance innovation with system sustainability, using refined models and the long-term impact on patient outcomes."

HEOR • Journal • Review • Acute Lymphocytic Leukemia • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Gene Therapies • Genetic Disorders • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Movement Disorders • Muscular Atrophy • Non-Hodgkin’s Lymphoma • Oncology • Ophthalmology • Rare Diseases • Retinal Disorders

The MFDS authorized Yescarta for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and for patients with primary mediastinal large B-cell lymphoma (PMBCL), a rare subtype recognized as distinct from DLBCL due to its unique clinical and pathological characteristics. (Korea Biomedical Review)

Korea approval • Diffuse Large B Cell Lymphoma • Primary Mediastinal Large B-Cell Lymphoma