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Favorable Real-World Outcomes of Lisocabtagene Maraleucel in Chronic Lymphocytic Leukemia
Abstract   Open access   Peer reviewed

Favorable Real-World Outcomes of Lisocabtagene Maraleucel in Chronic Lymphocytic Leukemia

Jennifer J. Huang, Jenna M Voutsinas, Niranjan S Khaire, Vincenzo Pizzuti, Leyla Shune, Matthew Lei, Rodrigo Fonseca, Mohammad Ammad-Ud-Din, Alan Skarbnik, Agrima Mian, …
Transplantation and cellular therapy, Vol.32(2), pp.S51-S52
02/2026
DOI: 10.1016/j.jtct.2025.12.080
url
https://doi.org/10.1016/j.jtct.2025.12.080View
Published (Version of record) Open Access

Abstract

Lisocabtagene maraleucel (liso-cel) was approved in the United States for CLL in 3/2024. Data regarding outcomes of liso-cel in CLL is limited to reports from TRANSCEND-CLL 004 which had strict inclusion and exclusion criteria. This work investigates the real-world efficacy and safety of liso-cel for patients with CLL. This is a multi-institutional retrospective study (Collaborative Assessment of Real-World Evidence of Lisocabtagene Maraleucel in Patients with Relapsed/Refractory CLL/SLL [CARE CAR-T CLL]) of patients with CLL who received commercial liso-cel in the United States. Patients with Richter transformation were excluded. Response was defined by iwCLL criteria. Patients who did not undergo a marrow biopsy but met other criteria for a complete response (CR) were categorized as unconfirmed CR (CRu). Patients in CR except for incomplete count recovery were categorized as CRi. CRS and ICANS were graded per ASTCT criteria. A total of 41 patients were identified with a median age of 68 years (range 37–80). Twenty-six patients (63%) had either del17p and/or mutated TP53, and 16 (39%) had complex karyotype (≥3 abnormalities) at time of liso-cel infusion (Table 1). Seven (20%) of patients had bulky disease (≥5 cm). Patients received a median of 6 prior lines of therapy (range 1-12), and 31 (76%) were previously treated with chemotherapy. Twenty-eight patients (68%) received bridging treatment that was stopped after leukapheresis, and 12 patients (29%) continued with bridging therapy after liso-cel infusion. Best CR/CRu/CRi rate was 59.0% (CR=18; CRu=2; CRi=3), and best overall response rate (ORR) was 85.4% (n=35) (Figure 1) with median time to best response of 30 days (IQR, 28-30 days). Measurable residual disease testing (MRD) by flow cytometry was done in 18 patients, and 12 patients (67%) had achieved undetectable MRD (uMRD). MRD by next generation sequencing (NGS) was done in 22 patients, and 11 (50%) patients had uMRD. Thirty-eight patients (92.7%) were alive at time of data collection. Median follow-up was 3.3 months (IQR, 2.4– 7.9 months). Thirty-five patients (87%) experienced any grade cytokine release syndrome (CRS), and 4 patients experienced grade 3 CRS (9.8%). Thirteen patients (31.7%) experienced any grade immune effector cell-associated neurotoxicity syndrome (ICANS), and 5 patients (12.1%) experienced grade 3 ICANS. There were no grade 4 or 5 CRS or ICANS (Figure 2). Real-world analysis of liso-cel for patients with relapsed/refractory CLL showed CR and ORR of 63.0% and 85.4%, respectively. Despite having a heavily pre-treated and chemotherapy-exposed population and with over half the patients having high-risk features, these response rates are higher than what was described in the TRANSCEND-CLL 004 clinical trial. Further updates and patients from additional collaborators will be presented at the meeting.

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