Lisocabtagene maraleucel (liso-cel) was effective and had a manageable safety profile in patients with Richter transformation (RT), according to a study of real-world data presented at the Society of Hematologic Oncology 2024 Annual Meeting in Houston, Texas.
The study included 30 patients who received liso-cel, an autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy. Ninety percent of patients had diffuse large B-cell lymphoma. The primary outcomes included objective response rate (ORR), complete response (CR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety. The safety analysis included an assessment of rates of cytokine release syndrome (CRS), immune effector cell–associated neurotoxicity syndrome (ICANS), and prolonged cytopenia (grade 4 thrombocytopenia or neutropenia at 30 days post-infusion).
Two patients had central nervous system involvement at liso-cel infusion, and 48% received bridging therapy. The median time from leukapheresis to infusion was 35 days. The median follow-up was 12.3 months, at which point the ORR was 76% among 29 evaluable patients. Of respondents, 66% achieved CR. The median time to first response was 1.1 months (range, 0–3.1). At data cutoff, median DOR was not reached, but the 12-month DOR rate was 77% (95% CI, 49.5–91).
Regarding survival outcomes, the median PFS and OS were not reached. The 12-month PFS was 54% (95% CI, 33–72), and the 12-month OS was 67% (95% CI, 44–83).
Seventy percent of patients experienced CRS; no cases were grade 3, 3% of cases were grade 4, and 3% of cases were grade 5. Corticosteroids plus tocilizumab was the most common treatment for CRS, used in 23% of cases, followed by tocilizumab alone, used in 20%. ICANS was reported in 47% of patients, with 17% of cases being grade 3, 10% being grade 4, and no grade 5 cases.
Corticosteroids alone were the most common ICANS treatment (23%), followed by antiepileptics plus corticosteroids (17%). Seventeen percent of patients experienced prolonged cytopenia. One patient had a second primary malignancy, which was gastrointestinal. Eight (27%) patients died, and seven of the deaths were due to disease progression.
“Patients with RT have poor prognosis and high unmet need. Here, we show that liso-cel provided meaningful clinical benefit and manageable safety, with low incidences of grade ≥3 CRS,” the study authors summarized. “The high CR rate is promising in this difficult-to-treat population, and longer follow-up in a larger cohort is needed.”
Reference
Abu-Sayeef Mirza AS, Winter A, Bharadwaj S, et al. Real-world outcomes of lisocabtagene maraleucel (liso-cel) in patients with Richter transformation (RT) from the Center for International Blood and Marrow Transplant Research (CIBMTR). Abstract #CLL-189. Presented at the Society of Hematologic Oncology 2024 Annual Meeting; Sept. 4-7, 2024; Houston, Texas.