To evaluate the safety, efficacy, and CAR T-cell persistence of obe-cel in patients aged ≥55 years with relapsed or refractory B-cell acute lymphoblastic leukaemia (R/R B-ALL).
Key Findings:
37.8% of infused patients were ≥55 years, with a median age of 65 years.
Overall remission rate (ORR) was 87.5%, with 91.3% for Philadelphia chromosome-positive patients.
Median duration of remission was 21.2 months; EFS and OS were 11.7 months and 16.8 months, respectively.
Low incidence of Grade ≥3 cytokine release syndrome (2.1%) and immune effector cell-associated neurotoxicity syndrome (10.4%).
Treatment-related mortality within 3 months was 4.2%.
Interpretation:
Obe-cel demonstrates a high and durable remission rate in older patients with R/R B-ALL, with a favorable safety profile.
Limitations:
Limited data on CAR T-cell persistence due to median not being estimable.
Study results are based on a post-hoc analysis, which may introduce bias.
Conclusion:
Obe-cel is effective and has a positive benefit/risk profile for treating patients aged ≥55 years with R/R B-ALL.