A post-hoc analysis found that the chimeric antigen receptor T-cell therapy obecabtagene autoleucel (obe-cel) produced durable remissions and maintained a favorable benefit-risk profile across all age groups. The analysis was presented at the 2025 European Hematology Association (EHA) Congress in Milan, Italy.
The US Food and Drug Administration approved obe-cel on November 8, 2024, for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) based on data from 65 patients in the FELIX trial. In that study, 42% of patients achieved complete remission within three months of infusion, with a median duration of remission of 14.1 months.
At the 2025 EHA Congress, investigators led by Bijal Shah, MD, MS, a clinician-researcher in the Department of Malignant Hematology at Moffitt Cancer, reported updated findings from a post-hoc analysis of the same trial that compared patients younger than 55 and those 55 and older. The analysis showed that patients in both groups achieved deep and durable remissions, with favorable overall response rates, event-free survival, and overall survival. Rates of severe cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome remained low in both groups.
“These findings indicate that obe-cel is effective and has a positive benefit-risk profile regardless of patient age, including in older adults with relapsed or refractory B-cell [ALL] even though few patients received consolidative stem cell transplant,” Dr. Shah and colleagues wrote.
Reference
Shah B, Yallop D, Jabbour E. Efficacy and safety outcomes of obecabtagene autoleucel (obe-cel) stratified by age in patients with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL). Abstract# S114. Presented at the European Hematology Association 2025 Congress; June 12-15, 2025; Milan, Italy.
