Obecabtagene autoleucel, or obe-cel approved for the treatment of relapsed or refractory adult B-cell acute lymphoblastic leukemia (ALL).
Approval of the CD19 chimeric antigen receptor T-cell therapy (CAR T) — designed to have a ‘fast-off’ kinetic” to minimize excessive activation of the programmed T cells and thereby increase T-cell persistence and reduce T-cell exhaustion.
FELIX study: The pooled analysis showed a complete response (CR) or CR with incomplete hematologic recovery (CR/CRi) rate of 77% and a CR rate of 57% at a median follow up of 11 months in 124 patients for treatment of relapsed or refractory adult B-cell acute lymphoblastic leukemia (ALL), at a median follow up of 11 months.
Among evaluable patients, 96% achieved minimal residual disease (MRD)-negative status.
Median duration of response was not reached.
Safety findings showed a low 2.4% and 7.1% rate of grade 3 or higher cytokine release syndrome (CRS) and/or grade 3 or higher immune effector cell-associated neurotoxicity syndrome (ICANS), respectively.
Patients underwent lymphodepletion with fludarabine as 4 x 30 mg/m2 and cyclophosphamide at 2 x 500 mg/m2.
Obe-cel was administered at a target dose of 410 x 106 CAR T cells as a split dose on days 1 and 10 based on pre-lymphodepletion bone marrow blast burden.
CAR T expansion was similar across the study cohorts, and CAR T persistence was ongoing in most responders at follow up.
A particular benefit was observed in patients’ low leukemia burden, defined as morphological remission per investigator assessment (less than 5% bone marrow blasts without extramedullary disease) as measured at screening or at the start of lymphodepletion, prior to obe-cel infusion.