Lisocabtagene maraleucel (liso-cel) is a chimeric antigen receptor (CAR) T-cell therapy that can be used to treat relapsed or refractory large B-cell lymphoma (R/R LBCL) in patients who have received one or more lines of systemic therapy. However, there is currently limited real-world data available on outcomes for patients with R/R LBCL treated with liso-cel. As such, using data collected from the Center for International Blood and Marrow Transplant Research, Jennifer L. Crombie, MD, Dana Farber Cancer Institute, Boston, Massachusetts, and colleagues set out to evaluate the real-world clinical effectiveness and safety of commercial liso-cel in this patient group.

The study included 323 patients with R/R LBCL, including those with high-risk disease, who received liso-cel infusion (conforming product only) between February 2021 and November 2022 across more than 50 treatment sites. In terms of patient characteristics, 81% of the participants had DLBCL not otherwise specified (NOS), 37% had an international prognostic index (IPI) of ≥3, 15% had prior transplants, 12% had high-grade B-cell lymphoma (HGBCL), and 6% had active central nervous system involvement (CNS). For 27% of the patients, their disease had transformed from indolent lymphoma. The median age of the participants was 70 years old.

The median number of prior lines of systemic therapy was 3 (range, 0-11), with 25% of patients having received ≥4 lines. The median time from diagnosis to liso-cel infusion was 1.4 years (range, 0.2-29.7 months). The median vein-to-vein time (from leukapheresis to liso-cel infusion) was 36 days (IQR, 34-42), which is consistent with clinical studies of liso-cel. The main outcome measures of the study were overall response rate (ORR), complete response (CR) or better, duration of response (DOR), progression-free survival (PFS), overall survival (OS), and risk of immune effector cell-associated neurotoxicity syndrome (ICANS) and cytokine release syndrome (CRS).

The results showed that the ORR was 79%, with a 65% CR rate, after a median follow-up of 7.4 months. The median time to response for the liso-cel treatment was 1.2 months (IQR, 1.0-3.1). At the time of data cutoff, the median rates for DOR, PFS, and OS had not been met. The 6-month DOR rate was 73% (95% CI, 66%-79%), the estimated 6-month PFS rate was 64%, and the OS rate was 82%.

Although 30% of the participants had ICANS, only 11% had severe or grade ≥3 events. Patients with ICANS were mostly treated with corticosteroids (12%) and corticosteroids/antiepileptics (5%). Within the 52% of patients that had CRS, only 3% had grade ≥3 events. Those with CRS were primarily treated with tocilizumab (20%) and corticosteroids/tocilizumab (12%). The attributed cause of death was grade 5 CRS for 3 patients and grade 5 ICANS for 3 patients. With the exception of 2 patients, all participants had concurrent causes of death, which included hemophagocytic lymphohistiocytosis (n = 2) and disease progression (n = 3).

The researchers found that, overall, a one-time infusion of liso-cel resulted in “deep and durable” responses in patients with R/R LBCL, including those with high-risk features characteristic of poor prognosis. When compared to patients who were treated with liso-cel in the TRANSCEND study, those in the real-world setting had similar baseline characteristics, including the percentage of patients who had received ≥4 lines of prior systemic therapy (26% vs 25%, respectively). The incidence of severe (grade ≥3) CRS and ICANS was low, with no CRS events reported in 48% of patients and no ICANS events reported in 70% of patients. Per these findings, Dr Crombie and colleagues suggest liso-cel as a therapeutic option for patients with R/R LBCL in a real-world setting.

Source: Crombie JL, Nastoupil LJ, Andreadis C, et al. Multicenter, real-world study in patients with R/R large B-cell lymphoma (LBCL) who received lisocabtagene maraleucel (liso-cel) in the United States (US). Presented at: 2023 ASH Annual Meeting & Exposition; December 9-12, 2023; San Diego, CA, and virtual; Abstract 104.