Yescarta (axicabtagene ciloleucel)
/ Cabaret Biotech, National Cancer Institute, Gilead, Fosun Kite
- LARVOL DELTA
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November 13, 2025
Axicabtagene Ciloleucel in Combination With Atezolizumab in Patients With Refractory Diffuse Large B-cell Lymphoma: The Phase 1/2 ZUMA-6 Trial.
(PubMed, Clin Cancer Res)
- "Safety and efficacy of this combination were consistent with axi-cel monotherapy. Correlative analyses could inform as to which LBCL patients may benefit from axi-cel and immune checkpoint inhibitor combinations."
Journal • P1/2 data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Thrombocytopenia
March 26, 2026
FLU-CART: Fludarabine exposure in patients undergoing Fludarabine based lymphodepletion prior to CAR-T cell therapy
(clinicaltrialsregister.eu)
- P4 | N=75 | Not yet recruiting | Sponsor: Universitair Ziekenhuis Gent
New P4 trial • Hematological Malignancies • Oncology
November 04, 2025
CAR T-cell therapy in secondary CNS lymphomas: A real-world study from the descar-t registry
(ASH 2025)
- P | "At the timeof CAR T-cell infusion, 109/195 (56%) patients were in complete (CR) or partial response (PR), and 84 (43%)had stable (SD) or progressive disease (PD) (missing data: 1%).One hundred thirty-eight (71%) patients received axi-cel, 26 (13%) tisa-cel, and 31 (16%) liso-cel. Efficacy and toxicity data, particularlywith respect to neurotoxicity, were consistent with those observed in systemic DLBCL. Further studies areneeded to support these results over the long term and to determine the optimal place of CAR T-cellswithin the therapeutic options of CNS lymphomas."
CAR T-Cell Therapy • Clinical • Real-world • Real-world evidence • B Cell Lymphoma • CNS Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Primary Central Nervous System Lymphoma • Secondary Central Nervous System Lymphoma
November 04, 2025
Mosunetuzumab and polatuzumab combined with axicabtagene ciloleucel induce high complete response rates at day+90 in Relapsed/Refractory large B-cell lymphoma
(ASH 2025)
- P2 | "Futility (assessed dynamically) was rejected after 11 pts achieved a CR at Day +90.Treatment consisted of 3 phases: following leukapheresis on Day -36, pts received bridging therapy withstep-up dosing of mosun IV (1 mg on Day -35, 2 mg on Day -28 and 60 mg on Day -21) combined withpola IV (1.8 mg/kg on Day -21); pts then received standard lymphodepletion with fludarabine andcyclophosphamide from Day -5 to Day -3, followed by axi-cel infusion on Day 0. Mosun-pola in combination with axi-cel was effective, inducing high complete response rates at Day +90.No increase in acute CAR-T related toxicities were seen. Follow-up to assess durability of CR is ongoing."
Clinical • B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Large B Cell Lymphoma • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Thrombocytopenia • CD79B
January 09, 2026
Health-related quality of life after second-line Axi-cel in transplant-ineligible patients with large B-cell lymphoma.
(PubMed, Blood Adv)
- P2 | "These findings indicate that axi-cel improves HRQoL regardless of transplant eligibility, supporting its use across a broad patient population. NCT04531046."
HEOR • Journal • B Cell Lymphoma • Fatigue • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation
March 25, 2026
Impact of age on outcomes after CD19 CAR T-cell therapy for large B-cell lymphomas.
(PubMed, Blood Neoplasia)
- "Patients received either axicabtagene ciloleucel (75%) or tisagenlecleucel (25%). CD19 CAR-T therapy is effective for older adults, and older age does not worsen mortality. Older age is associated with higher ICANS risk and should guide patient selection."
Journal • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation
March 25, 2026
Spinal cord disease following CAR T-cell therapy with axicabtagene ciloleucel in a patient with high-grade B-cell lymphoma.
(PubMed, Leuk Lymphoma)
- No abstract available
Journal • B Cell Lymphoma • CNS Disorders • Hematological Malignancies • High-grade B-cell lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology
December 13, 2021
Axicabtagene Ciloleucel as Second-Line Therapy for Large B-Cell Lymphoma.
(PubMed, N Engl J Med)
- P3 | "Axi-cel therapy led to significant improvements, as compared with standard care, in event-free survival and response, with the expected level of high-grade toxic effects. (Funded by Kite; ZUMA-7 ClinicalTrials.gov number, NCT03391466.)."
Clinical • Journal • Bone Marrow Transplantation • CNS Disorders • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Inflammation • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation
November 04, 2025
Axi-cel delivers similar outcomes regardless of ASCT-eligibility in second line R/R LBCL: Combined data from ZUMA-7 and ALYCANTE
(ASH 2025)
- P2, P3 | "This improvement was clinically meaningful inALYCANTE (+10.6), but did not reach the threshold in ZUMA-7 (+9.6). Physical function also declinedtransiently in both trials at Day 50 (-12.9 for both), with ZUMA-7 showing statistically significantimprovement from baseline by Month 24 (+4.1), while ALYCANTE showed a smaller, non-significant gain(+2.4).ConclusionEfficacy, safety, and HRQoL patterns were consistent across both ZUMA-7 and ALYCANTE populations.These data support the use of axi-cel regardless of transplant eligibility and reinforce the transition fromASCT to CAR T eligibility in 2L therapy."
Clinical • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma
March 21, 2026
Early Steroid and Anakinra Use to Manage Axicabtagene Ciloleucel Toxicity Reduces the Total Duration of CRS and ICANS.
(PubMed, Blood Adv)
- "Axicabtagene ciloleucel (axi-cel) is an effective CAR-T cell therapy for relapsed or refractory (R/R) large B-cell lymphoma (LBCL). However, efficacy outcomes, ICU admission rates, and hospitalization length were similar between the cohorts. This study supports earlier intervention for CAR-T toxicities and establishes anakinra as a safe and effective alternative toxicity management drug to tocilizumab."
Journal • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology
March 11, 2026
Marginal Zone Lymphoma
(ICKSH 2026)
- "Bendamustine -rituximab demonstrates an ORR of ~93% and CR of ~81% in EMZL, with 5 -year PFS of ~8 0%. Lenalidomide - rituximab (R² ) offers an effective chemotherapy -free option with ORR of 93%, CR of 70%, and 5 - year OS of 96%...Zanubrutinib is now the pref erred agent based on the MAGNOLIA trial, demonstrating an ORR of 68%, CR of 26%, with favorable safety profile including low rates of atrial fibrillation (3%)...Emerging therapies include CAR -T cell therapy (axicabtagene ciloleucel showed ORR 77% in ZUMA -5), CD20×CD3 bispecific antibodies (mosunetuzumab, epcoritamab, glofitamab), non - covalent BTK inhibitors (pirtobrutinib), and antibody -drug conjugates...Key unmet needs include MZL -specific clinical trials, understanding of transformation biology, and development of novel targeted therapies. With the expanding therapeutic armamentarium, the treatment paradigm is shifting toward targeted, immune -based strategies, offering improved outcomes for..."
Atrial Fibrillation • Cardiovascular • Endocrine Disorders • Extranodal Marginal Zone Lymphoma • Hematological Malignancies • Hepatitis C • Hepatology • Immunology • Indolent Lymphoma • Infectious Disease • Lyme Disease • Lymphoma • Lymphoplasmacytic Lymphoma • Marginal Zone Lymphoma • Nodal Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Sjogren's Syndrome • Splenic Marginal Zone Lymphoma • Waldenstrom Macroglobulinemia • BIRC3 • CCND1 • CD19 • CD20 • CD5 • CD79A • CREBBP • EP300 • KMT2D • MALT1 • MME • MYD88 • NOTCH2 • TNFAIP3
February 07, 2026
A REAL-WORLD ANALISYS OF AXICABTAGENE CILOLEUCEL AS SECOND LINE TREATMENT IN PATIENTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMAS: A REPORT FROM RETE EMATOLOGICA PUGLIESE (REP)
(EBMT 2026)
- "Bridging therapy was administered to 29/36 patients, most commonly polatuzumab-based regimens (52%), followed by platinum/ARA-C combinations (38%) and radiotherapy (10%). In this real-world cohort, second-line Axi-cel in R/R DLBCL demonstrated high early response rates, manageable toxicity, and survival outcomes comparable to pivotal trials. Our experience supports the effectiveness of Axi-cel in routine practice and highlights the importance of integrated post–CAR-T therapeutic strategies, including bispecific antibodies, in the modern management of refractory DLBCL."
Clinical • Real-world • Real-world evidence • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Septic Shock
February 07, 2026
THIOTEPA, CYCLOPHOSPHAMIDE AND FLUDARABINE CONDITIONING REGIMEN FOR ADULT PATIENTS WITH NON-HODGKIN LYMPHOMA UNDERGOING ALLOGENEIC STEM CELL TRANSPLANTATION: IMPACT OF DONOR MISMATCH ON OUTCOME
(EBMT 2026)
- "Median number of lines before transplant were 3 (range 1-10); 8 (23%) pts received autologous stem cell transplant, 6 (18%) pts CAR-T (3 tisagenlecleucel, 1 brexucabtagene autoleucel, 1 axicabtagene ciloleucel) and 6 (18%) bispecific antibodies (4 glofitamab, 2 mosunetuzumab). Our data highlight the efficacy of TCF conditioning for disease control in heavily pretreated lymphomas, with 1-year PFS and OS of 66% and 71% respectively. HSCT from mismatched donors had higher complications rate (mainly GVHD, despite the prevalent use of PT-Cy GVHD prophylaxis platform) and a tendency of lower 1-year OS."
Clinical • Bone Marrow Transplantation • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Richter's Syndrome • T Cell Non-Hodgkin Lymphoma • Transplantation
February 07, 2026
SALVAGE STRATEGIES AND OUTCOMES AFTER EARLY-LINE CD19 CAR T-CELL THERAPY FAILURE IN LARGE B-CELL LYMPHOMA
(EBMT 2026)
- "Prior CAR-T exposure included axicabtagene ciloleucel (51%), isoantigenic maraleucel (24%), tisagenlecleucel (22%), and point-of-care products (4%); 70% had received CAR-T therapy in the third-line setting.The overall response rate (ORR) to first salvage therapy was 50%, including 34% complete and 16% partial responses...1B–C), most commonly including bispecific antibodies (n=54), involved-site radiotherapy (n=40), bendamustine-based therapy (n=24), and polatuzumab-containing therapy (n=24); treatment categories were not mutually exclusive... In this large multicenter cohort of LBCL patients relapsing after early-line CD19 CAR-T therapy, salvage treatment achieved clinically meaningful responses regardless of prior CAR-T treatment line. Early post–CAR-T relapse identified a high-risk subgroup with poor outcomes. Immunotherapy-based salvage strategies showed the most favorable activity, supporting their preferential consideration and underscoring the need for prospective..."
CAR T-Cell Therapy • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma
March 06, 2026
THE TOTAL COST OF CARE AND BUDGET IMPACT OF INTRODUCING MOSUNETUZUMAB PLUS POLATUZUMAB VEDOTIN FOR SECOND-LINE OR LATER (2L+) TREATMENT OF RELAPSED/REFRACTORY LARGE B-CELL LYMPHOMA (LBCL) TO A UNITED STATES (US) HEALTH PLAN
(ISPOR 2026)
- P3 | "Comparators included rituximab plus gemcitabine and oxaliplatin (R-GemOx) per the Phase 3 SUNMO trial (NCT05171647) and FDA-approved treatments, including axicabtagene ciloleucel (Axi-cel), lisocabtagene maraleucel (Liso-cel), tisagenlecleucel (Tisa-cel), tafasitamab plus lenalidomide (Tafa+len), glofitamab, epcoritamab, loncastuximab tesirine (Lonca), and polatuzumab plus bendamustine and rituximab (Pola-BR). Adding Mosun-Pola to a US payer formulary resulted in a small budget impact that remained robust in OWSA. TCC for Mosun-Pola was lower versus treat-to-progression epcoritamab, Tafa+len and CAR-T regimens. Given the small budget impact and improved clinical outcomes versus R-GemOx demonstrated in the Phase 3 SUNMO trial, Mosun-Pola is a meaningful option for 2L+ relapsed/refractory LBCL."
Clinical • Cost of care • HEOR • B Cell Lymphoma • Hematological Malignancies • Inflammation • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma
February 07, 2026
PICKING STRONG BRIDGING REGIMENS BEFORE CD19 CAR-T CELL THERAPY OF LARGE B CELL LYMPHOMA – HOW HISTOLOGY AND HIGH LDH IMPACT LONG-TERM OUTCOMES
(EBMT 2026)
- "Bridging choices were grouped as No-Bridging, radiotherapy, ancient (Pixantrone, CHOP-variants), intensive (e.g., R-DHAP, R-MATRIX), R-gemcitabine/oxaliplatin (R-GemOx), sequential, R-Polatuzumab (R-Pola), or R-Pola-Bendamustine (Pola-BR)... 508 patients (384 DLBCL-NOS, 124 trFL) treated with Axi-cel (65.2%), Tisa-cel (25.4%), or Liso-cel (9.4%) were included... Our dataset is limited by the retrospective nature including a possible bias that worse bridging outcome may prevent patients from CAR-T infusion. We found outcomes were distinct for trFL and DLBCL-NOS. In NOS, responses to bridging as well as any LDH-elevation strongly and independently influenced outcomes."
CAR T-Cell Therapy • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma
March 14, 2026
SALVAGE STRATEGIES AND OUTCOMES AFTER EARLY-LINE CD19 CAR T-CELL THERAPY FAILURE IN LARGE B-CELL LYMPHOMA
(EBMT 2026)
- "Prior CAR-T exposure included axicabtagene ciloleucel (51%), isoantigenic maraleucel (24%), tisagenlecleucel (22%), and point-of-care products (4%); 70% had received CAR-T therapy in the third-line setting.The overall response rate (ORR) to first salvage therapy was 50%, including 34% complete and 16% partial responses...1B–C), most commonly including bispecific antibodies (n=54), involved-site radiotherapy (n=40), bendamustine-based therapy (n=24), and polatuzumab-containing therapy (n=24); treatment categories were not mutually exclusive... In this large multicenter cohort of LBCL patients relapsing after early-line CD19 CAR-T therapy, salvage treatment achieved clinically meaningful responses regardless of prior CAR-T treatment line. Early post–CAR-T relapse identified a high-risk subgroup with poor outcomes. Immunotherapy-based salvage strategies showed the most favorable activity, supporting their preferential consideration and underscoring the need for prospective..."
CAR T-Cell Therapy • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma
February 07, 2026
IMPACT OF PRIOR B-CELL-DIRECTED IMMUNOTHERAPY ON THE OUTCOME OF CD19 CAR T-CELL THERAPY IN AGGRESSIVE B-CELL LYMPHOMA
(EBMT 2026)
- "Background: B-cell-directed immunotherapies (BCDI), such as CD19 chimeric antigen receptor T-cell therapy (CAR-T), antibody-drug conjugates including polatuzumab vedotin (pola), and bispecific antibodies (BSA) have revolutionized the treatment of large B-cell lymphoma (LBCL)...BCDI exposure (excluding rituximab) prior to CAR-T, including bridging therapy, was categorized as BSA, pola-based regimens, and other BCDI, including obinutuzumab, brentuximab vedotin, and loncastixumab tesirine...BCDI-exposed patients more often had ≥3 prior treatment lines (54.8% vs. 43.0%, p<0.001), more frequent axicabtagene ciloleucel usage (63.8% vs. 56.0%, p=0.012), and higher complete/partial remission (CR/PR) rates at lymphodepletion (40.2% vs. 29.1%, p<0.001).Three-year overall survival (OS) was numerically inferior with prior BCDI (41.3% vs. 49.7%, p=0.07), without differences in progression-free survival (PFS) (35.0% vs. 37.2%), relapse incidence (52.0% vs. 51.5%), or NRM (13.0%..."
CAR T-Cell Therapy • B Cell Lymphoma • Hematological Malignancies • Infectious Disease • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma
February 07, 2026
ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION AFTER FAILING CAR-T THERAPY FOR PATIENTS WITH RELAPSED/REFRACTORY LARGE B CELL LYMPHOMA: SPANISH MULTICENTER GETH-TC/GELTAMO STUDY
(EBMT 2026)
- "75% of the patients received axi-cel; 19/44 (44%) had achieved CR after CAR-T as best response. Our data confirmed that allo-HSCT is a feasible and a potentially curative option for eligible patients with R/R LBCL failing after CAR-T therapy, with a high PFS and low NRM. Most of the patients received targeted therapies as a bridging to allo-HSCT such as bispecific antibodies, polatuzumab and anti-PD1/PDL1 based regimens. Further prospective studies are needed to confirm these results."
CAR T-Cell Therapy • Clinical • Acute Graft versus Host Disease • B Cell Lymphoma • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Transplantation
August 08, 2025
NKTR-255 Enhances Complete Response Following CD19 CAR-T in Patients with Relapsed/Refractory Large B-cell Lymphoma.
(PubMed, Blood Adv)
- P2/3 | "In this phase 2, randomized, double-blind, placebo-controlled, multicenter study of NKTR-255 versus placebo following CD19 CAR T-cell therapy, eligible patients with R/R LBCL were treated with one of two FDA-approved CAR T-cell products, axicabtagene ciloleucel (axi-cel) or lisocabtagene maraleucel (liso-cel). NKTR-255 was well-tolerated, safe, and augmented CR6 for LBCL patients. Based on the findings, additional confirmatory studies with NKTR-255 as adjuvant treatment to CAR T-cell, including other cellular therapies, are warranted (ClinicalTrials.gov number NCT05664217)."
Clinical • Journal • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19 • CD8
March 19, 2026
Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy
(clinicaltrials.gov)
- P3 | N=550 | Not yet recruiting | Sponsor: Kite, A Gilead Company
New P3 trial • B Cell Lymphoma • Hematological Malignancies • Indolent Lymphoma • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology
February 12, 2025
Three-year follow-up analysis of first-line axicabtagene ciloleucel in high-risk large B-cell lymphoma (ZUMA-12).
(PubMed, Blood)
- P2 | "Further assessments are needed to determine its benefit versus first-line standard-of-care. This trial was registered at clinicaltrials.gov, as #NCT03761056."
Journal • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology
November 04, 2025
Phase II, single-arm, open-label, multicenter study: Efficacy of adjunctive Bruton's tyrosine kinase inhibitor (BTKi) zanubrutinib and chimeric antigen receptor (CART) in aggressive B-cell non-hodgkins lymphoma (aNHL)
(ASH 2025)
- "48% received bridging, 52% received CART 2nd line and 48% ≥3rd line; 78% received axi-cel and 22% liso-cel.Median length of ZLI was 7 days (range 7-10). In pts with R/R aNHL, ZLI prior to CD19 CART apheresis followed by ZM post CART resultedin 6-mo CR rates and 12-18 mo duration of CRs above historical rates reported for CART alone. Additionalstudies are needed to clarify the impact of Z exposure on changes in the TME and therapeutic effects ofCART. The safety profile of ZM was manageable with low rates of G3 toxicities."
Clinical • IO biomarker • P2 data • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Indolent Lymphoma • Infectious Disease • Leukopenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • T Cell Histiocyte Rich Large B Cell Lymphoma • CD8 • ENTPD1 • PD-1 • PD-L1
July 16, 2022
Patient-reported outcomes in ZUMA-7, a phase 3 study of axicabtagene ciloleucel in second-line large B-cell lymphoma.
(PubMed, Blood)
- P3 | "Axi-cel showed clinically meaningful improvements in QoL over SOC. Superior clinical outcomes and favorable patient experience with axi-cel should help inform treatment choices in second-line R/R LBCL."
Journal • P3 data • Patient reported outcomes • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology
November 06, 2024
5-Year Follow-up Analysis from ZUMA-5: A Phase 2 Trial of Axicabtagene Ciloleucel (Axi-Cel) in Patients with Relapsed/Refractory Indolent Non-Hodgkin Lymphoma
(ASH 2024)
- "After the prior analysis, there were no lymphoma-specific deaths, and only 1 late progression event occurred in FL, indicating the curative potential of axi-cel in iNHL. SN and JC contributed equally."
Clinical • P2 data • Bladder Cancer • Follicular Lymphoma • Genito-urinary Cancer • Hematological Malignancies • Indolent Lymphoma • Infectious Disease • Lymphoma • Marginal Zone Lymphoma • Myelodysplastic Syndrome • Non-Hodgkin’s Lymphoma • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • CCR7
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