Tisagenlecleucel can produce responses in children and young adults with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL), according to research presented at the EHA 2022 Hybrid Congress.
Tisagenlecleucel produced an overall response rate of 32.1%, and the median progression-free survival (PFS) was 2.5 months.
These results come from the phase 2 BIANCA trial (ClinicalTrials.gov Identifier: NCT03610724). The trial enrolled 34 patients with R/R B-NHL, 33 of whom received an infusion of tisagenlecleucel.
At baseline, the patients’ median age was 13.0 years (range, 3-22 years). The most common lymphoma subtypes were Burkitt lymphoma (54.5%), diffuse large B-cell lymphoma (30.3%), and primary mediastinal B-cell lymphoma (9.1%).
Most patients (87.9%) had stage III or IV disease, 15.2% had primary refractory disease, 30.3% had disease that was refractory at relapse, and 54.5% had relapsed or progressive disease. The patients had received a median of 2 prior lines of therapy (range, 1-3), and 18.2% had a prior autologous transplant.
Patients received 1 dose of tisagenlecleucel after optional bridging chemotherapy. The median time from tisagenlecleucel infusion to data cutoff was 16 months (range, 6-30 months), and the median follow-up was 8 months (range, 0.5-30 months).
The efficacy population included 28 patients because 4 patients had achieved a complete response prior to tisagenlecleucel infusion, and 1 patient had no baseline scan.
The overall response rate was 32.1%, with 7.1% of patients achieving a complete response and 25.0% having a partial response.
The median PFS was 2.5 months, and the 12-month PFS rate was 23%. The median overall survival (OS) was 11.4 months, and the 12-month OS rate was 47%.
The safety analysis included 33 patients. Treatment-emergent grade 3 or higher adverse events (AEs) were reported in 100% of patients, with serious AEs reported in 69.7%.
Cytokine release syndrome (CRS) occurred in 69.7% of patients, and all cases were grade 1-3. The median time to CRS onset was 6 days (range, 1-130 days), and the median duration of CRS was 5 days (range, 1-13 days).
Neurologic events (NEs) were reported in 27.3% of patients, and 15% of patients had a grade 3 or higher NE. The median time to NE onset was 8 days (range, 3-48 days), and the median duration of NEs was 9 days (range, 1-21 days).
Fatalities, occurring in 49% of patients, were all deemed unrelated to the study treatment.
Disclosures: This research was supported by Novartis. The presenter declared affiliations with Roche, Bristol Myers Squibb, Novartis, Celgene, and Adaptimmune.
Minard-Colin V, Buechner J, Locatelli F, et al. Efficacy and safety of tisagenlecleucel in pediatric and young adult patients (pts) with relapsed or refractory (R/R) mature B-cell non-Hodgkin lymphoma (NHL): The phase II BIANCA study. Presented at EHA 2022; June 9-12, 2022. Abstract S255.