Originally published by our sister publication Clinical Oncology News

By Clinical Oncology News Staff

The FDA approved obecabtagene autoleucel (Aucatzyl, Autolus Inc.), a CD19-directed genetically modified autologous T-cell immunotherapy, for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Efficacy was evaluated in FELIX (ClinicalTrials.gov. Identifier: NCT04404660), an open-label, multicenter, single-arm trial that enrolled adults with relapsed or refractory CD19-positive B-cell ALL. Enrolled patients were required to have relapsed following a remission lasting 12 months or less, relapsed or refractory ALL after two or more prior lines of systemic therapy, or disease that was relapsed or refractory three or more months after allogeneic stem cell transplantation. 

The major efficacy outcome measures were rate and duration of complete remission (CR) achieved within three months after infusion. Additional outcome measures were rate and duration of overall complete remission, which includes CR and CR with incomplete hematologic recovery at any time. Of the 65 patients evaluable for efficacy, 27 (42%; 95% CI, 29%-54%) achieved CR within three months. The median duration of CR achieved within three months was 14.1 months (95% CI, 6.1 months to not reached). 

The prescribing information has a boxed warning for cytokine release syndrome (CRS), immune effector cell–associated neurotoxicity syndrome (ICANS) and T-cell malignancies. CRS occurred in 75% (grade 3; 3%) and neurologic toxicities in 64% (grade ≥3; 12%), including ICANS in 24% (grade ≥3; 7%). The most common non-laboratory adverse reactions (incidence ≥20%) included CRS, unspecified infectious pathogen, musculoskeletal pain, viral infections, fever, nausea, bacterial infectious disorders, diarrhea, febrile neutropenia, ICANS, hypotension, pain, fatigue, headache, encephalopathy and hemorrhage.

Based on a press release from the FDA.