{"doi":"10.1002/hon.70093_143","title":"143 | REAL‐WORLD OUTCOMES OF AXICABTAGENE CILOLEUCEL (AXI‐CEL) FOR THE TREATMENT OF RICHTER TRANSFORMATION TO LARGE B‐CELL LYMPHOMA (RT‐LBCL)","abstract":"Introduction: There are limited published data on the effectiveness and safety of chimeric antigen receptor (CAR) T-cell therapy for treatment of RT-LBCL, an aggressive lymphoma arising in the setting of underlying chronic lymphocytic leukemia that is associated with poor prognosis. Herein, we report real-world outcomes in the largest cohort of patients (pts) with RT who were treated with axi-cel. Methods: Adult pts enrolled in the Center for International Blood and Marrow Transplant Research (CIBMTR) data registry who received axi-cel for RT-LBCL between October 2017 and August 2023 were included. Effectiveness outcomes included objective response rate (ORR), complete response (CR) rate, duration of response (DOR), incidence of relapse/progressive disease (REL/PD), progression-free survival (PFS), and overall survival (OS). Safety outcomes included cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) by ASTCT consensus grade, non-relapse mortality (NRM), and other adverse events. Outcomes were analyzed descriptively. Results: A total of 91 pts with RT were identified. At time of axi-cel infusion, 48 (53%) pts were aged ≥ 65 years (median, 66 years; range, 32–83), 78 (86%) had a reported Eastern Cooperative Oncology Group (ECOG) performance score 0–1, and 71 (78%) had clinically significant comorbidities. Median time from RT-LBCL diagnosis to axi-cel infusion was 9.9 mo (range, 2–283). Pts received a median of 3 (range, 1–8) lines of therapy between RT diagnosis and infusion, and 17 (19%) had prior hematopoietic cell transplantation (7% autologous; 12% allogeneic). Additional data on disease and treatment history will be provided in the presentation. Median time from leukapheresis to infusion was 29 days (IQR, 26–34). Bridging therapy was given to 47 (53%) pts. At a median follow-up of 26 mo (range, 0.3–59), ORR was 68% (95% CI: 58–78) with a CR rate of 53% (95% CI: 42–63). Median DOR was 19 mo (95% CI: 5-not reached). Median PFS was 5 mo (95% CI: 3–9) and OS was 16 mo (95% CI: 10–41), with encouraging response durability beyond 12 mo (Figure). Cumulative incidence of REL/PD at 12 mo was 50% (95% CI: 39–60). CRS was reported in 67 (74%) pts (8% Grade ≥ 3), with a median duration of 6 days. ICANS was reported in 40 (44%) pts (27% Grade ≥ 3), with a median duration of 8 days. Prolonged cytopenia by Day 30 was reported in 30% of pts (neutropenia, 7%; thrombocytopenia, 27%); 48% of pts had clinically significant infections. Cumulative incidence of NRM at 12 mo was 9% (95% CI: 4–16). Conclusion: In the largest study of real-world pts with RT treated with axi-cel to date, promising effectiveness and sustained responses were observed in a population with high unmet medical need. With a comparable safety profile to that observed in other LBCL subtypes, these findings support the use of axi-cel for RT-LBCL. Further study is warranted in this difficult-to-treat population. Research funding declaration: Kite, a Gilead Company; US National Institutes of Health NCI Cellular Immunotherapy Data Resource [CIDR] and NCI, NHLBI and NIAID for the Resource for Hematopoietic Cell Transplantation and Adoptive Cell Therapy Keywords: non-Hodgkin; cellular therapies Potential sources of conflict of interest: A. M. Winter Consultant or advisory role: BeiGene, AstraZeneca, and BTG Pharmaceuticals C. Lau Employment or leadership position: Kite, a Gilead Company Stock ownership: Gilead Sciences M. Shadman Employment or leadership position: Bristol Myers Squibb (spouse) Consultant or advisory role: AbbVie, Adaptimmune, Adaptive Biotechnologies, AstraZeneca, Atara Biotherapeutic, BeiGene, Bristol Myers Squibb, Lilly, Epizyme, Fate Therapeutics, Genentech, Innate Pharma, Kite, a Gilead Company, MEI Pharma, Merck, MorphoSys/Incyte, Mustang Bio, Pharmacyclics, Regeneron, Sound Biologics, and TG Therapeutics Other remuneration: research funding from AbbVie, AstraZeneca, Atara Biotherapeutics, BeiGene, Bristol Myers ","journal":"Hematological Oncology","year":2025,"id":553174,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":1,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9381,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2025-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1249394,"name":"Constance Lau","orcid":null,"position":1,"is_corresponding":false},{"id":233391,"name":"Mazyar Shadman","orcid":"0000-0002-3365-6562","position":2,"is_corresponding":false},{"id":282395,"name":"Alex F. Herrera","orcid":"0000-0002-9665-7415","position":3,"is_corresponding":false},{"id":11101,"name":"Caron A. Jacobson","orcid":"0000-0002-0180-0654","position":4,"is_corresponding":false},{"id":196645,"name":"F. L. Locke","orcid":null,"position":5,"is_corresponding":false},{"id":247184,"name":"Sairah Ahmed","orcid":"0000-0001-7302-8299","position":6,"is_corresponding":false},{"id":1449874,"name":"Yi Lin","orcid":"0000-0001-5222-3060","position":7,"is_corresponding":false},{"id":1450230,"name":"Sanjeevi Bharadwaj","orcid":null,"position":8,"is_corresponding":false},{"id":122965,"name":"Mehdi Hamadani","orcid":"0000-0001-5372-510X","position":9,"is_corresponding":false},{"id":527665,"name":"Z. Feng","orcid":null,"position":10,"is_corresponding":false},{"id":122968,"name":"Waleska S. Pérez","orcid":null,"position":11,"is_corresponding":false},{"id":284115,"name":"Zhen‐Huan Hu","orcid":"0000-0002-3303-8991","position":12,"is_corresponding":false},{"id":659200,"name":"Timothy Best","orcid":null,"position":13,"is_corresponding":false},{"id":243288,"name":"Bing Du","orcid":"0000-0002-5402-6527","position":14,"is_corresponding":false},{"id":792730,"name":"L. J. Martin","orcid":null,"position":15,"is_corresponding":false},{"id":415400,"name":"Liana Nikolaenko","orcid":"0000-0003-0542-1712","position":16,"is_corresponding":false},{"id":122967,"name":"Marcelo C. Pasquini","orcid":"0000-0003-1579-2293","position":17,"is_corresponding":false},{"id":273365,"name":"Allison Winter","orcid":"0000-0002-8437-7539","position":0,"is_corresponding":true}],"reference_count":0,"raw_metadata":null,"created_at":"2026-07-19T02:54:41.819682Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}