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Children and young adults with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) are at increased risk for subsequent morbidity with each salvage treatment
.
Tisagenlecleucel is a CD19-directed chimeric antigen receptor (CAR) T-cell therapy approved for use in children and young patients with R/R B-ALL, as well as adult patients
with recurrent or refractory diffuse large B-cell lymphoma and relapsed or refractory follicular lymphoma.
In the Phase 2 ELIANA trial, the first analysis, Tisagenlecleucel induced high remission rates (81%) in children and young patients with R/R B-ALL, and 59% of responding patients remained relapse-free at 12 months
.
The latest efficacy, safety, and patient-reported quality of life outcomes
in 79 children and young adults with R/R B-ALL are reported here.
Remission duration, event-free survival, and overall survival for all patients
As of this analysis, the median follow-up was 38.
8 months, and the overall response rate was 82%.
The median event-free survival was 24 months, and median overall survival was not reached
.
The event-free survival rate at 3 years was 44% and the overall survival rate was 63%.
The estimated 3-year recurrence-free survival rate with or without review of follow-up treatment was 52% and 48%,
respectively.
There were no new or unexpected long-term adverse effects
.
Grade 3/4 adverse reactions
were reported in 29% of patients one year after Tisagenlecleucel infusion.
There was no increase
in the rate of grade 3/4 infection after one year of Tisagenlecleucel infusion.
Patients reported improvements in life therapy after Tisagenlecleucel infusion, up to 36 months
.
Taken together, the results demonstrate the promising long-term safety and activity
of Tisagenlecleucel as a salvage treatment option for previously treated R/R B-ALL in children and young adults.
Original source:
Theodore W.
Laetsch, et al.
Three-Year Update of Tisagenlecleucel in Pediatric and Young Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia in the ELIANA Trial.
Journal of Clinical Oncology.
November, 2022.
https://ascopubs.
org/doi/full/10.
1200/JCO.
22.
00642
