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Tisagenlecleucel Therapy Produces High Response Rates in Patients With High-Risk R/R FL
Efficacy data of tisagenlecleucel in adult patients with high-risk relapsed/refractory (R/R) follicular lymphoma (FL) were presented at the 2021 American Society of Hematology (ASH) Annual Meeting to update results from the overall population at a median follow-up of 17 months and report a subgroup analysis of patients with high-risk disease from the ELARA trial.
“Primary analysis of the single-arm, multicenter, Phase II ELARA trial in R/R FL demonstrated that tisagenlecleucel resulted in high overall (ORR) and complete response rates (CRR), and prolonged progression-free survival (PFS) at a median follow-up of 11 months,” explained Dr Catherine Thieblemont, MD, PhD, Department of Hemato-Oncology, Paris, France, and colleagues.
Patients included in the study had confirmed R/R FL after ≥2 lines of therapy or had relapsed after autologous stem cell transplant (ASCT). Study endpoints included objective response rate (ORR), CRR, PFS, and duration of response (DOR). Tisagenlecleucel (0.6-6×108 CAR+ viable T cells) was given after lymphodepleting chemotherapy (fludarabine [25 mg/m2] plus cyclophosphamide [250 mg/m2] once daily for 3 days or bendamustine [90 mg/m2] once daily for 2 days).
A total of 97 patients received tisagenlecleucel and 94 were evaluable for primary efficacy analysis. In the overall ELARA population, high and durable responses were seen (ORR 86.2%, CRR 69.1%, 9-month DOR 76%, and 12-month PFS 67%). PFS was 85.5 percent in CR patients at 9 months.
“Compared with corresponding low-risk subgroups, there was a numerical reduction in CRR for high-risk subgroups (POD24 59% vs 87.9%; high TMTV 40% vs 76.4%; ≥5 prior lines of therapy 59.3% vs 73.1%). A reduction in 12-month PFS was also identified for patients in these subgroups: POD24 (60.8% vs 77.9%), high baseline TMTV (54.5% vs 68.5%), and ≥5 prior lines of therapy (59.6% vs 69.7%),” wrote Dr Thieblemont and colleagues.
High TMTV was associated with bulky disease, high FLIPI, and high CRP. Only POD24 and high TMTV were associated with shorter PFS.
“With 17-month median follow-up, tisagenlecleucel produced high ORR and CRR, and was associated with durable response and promising 12-month PFS in patients with R/R FL and 2+ prior lines of therapy. Safety was consistent with known tisagenlecleucel profile. POD24 and high TMTV were independently associated with PFS. These results suggest that tisagenlecleucel can induce high rates of durable response, including most patients in the high-risk disease subgroups, who have poor prognosis with current non-CAR-T cell therapies,” concluded Dr Thieblemont and colleagues.
Catherine T, Dickinson M, Martinez-Lopex J, et al. Efficacy of Tisagenlecleucel in Adult Patients (Pts) with High-Risk Relapsed/Refractory Follicular Lymphoma (r/r FL): Subgroup Analysis of the Phase II Elara Study. Presented at: the 2021 ASH Annual Meeting; Dec. 11-14; 2021; Abstract 131.
