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Autolus Therapeutics to Present Clinical Data Updates at the American Society of Hematology (ASH) Annual Meeting 2025

AUTL
  • Autolus Therapeutics announced the online publication of five abstracts regarding its CD19-targeting CAR T-cell therapy, obecabtagene autoleucel (obe-cel), for presentation at the ASH Annual Meeting in Orlando from December 6-9, 2025.
  • Abstract 302 presents initial safety, efficacy, \& pharmacokinetic data from the CARLYSLE study showing obe-cel has a favorable safety profile \& deep B-cell depletion in patients with severe, refractory systemic lupus erythematosus (SLE).
  • Abstract 4429 indicates that a higher percentage of central memory cells (Tcm) in the drug product predicts positive clinical outcomes, including overall survival, while CD25+ HLADR+ CD4+ cells in leukapheresis products independently predicted less favorable outcomes.
  • Abstract 740 reports preliminary findings from the CATULUS trial in pediatric patients with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL), showing a 95% overall response rate, low rates of high-grade CRS \& ICANS, \& nearly 90% of responders maintaining ongoing remission.
  • Abstract 4060 demonstrates that CAR T-cell persistence at Month 3, measured by droplet digital PCR, is associated with longer event-free survival \& overall survival in adult patients with R/R B-ALL who remain in remission.
  • Abstract 4031 confirms that commercially available reagents targeting the G4S linker can reliably monitor obe-cel expansion \& persistence, whereas reagents based on the CD19 protein are unsuitable due to the unique CAT19 binder structure.
  • CEO Dr. Christian Itin stated that the data underscores the potential for obe-cel to produce long-term outcomes in severe hematological \& autoimmune populations \& noted upcoming real-world data from the ROCCA consortium.
  • Obe-cel, marketed as AUCATZYL, was approved by the FDA on November 8, 2024, for adult patients with relapsed or refractory B-cell precursor ALL, with conditional marketing authorization granted by the MHRA in the UK \& EMA in the EU in 2025.
  • Safety warnings highlight risks of Cytokine Release Syndrome (CRS), Neurologic Toxicities (ICANS), Secondary Hematological Malignancies, prolonged cytopenias, infections, \& hypogammaglobulinemia.
  • In the FELIX study of 100 patients, CRS occurred in 75% of patients (3% Grade 3), neurologic toxicities in 64% (12% Grade ≥3), \& 9% of patients experienced fatal adverse reactions primarily due to infections or ICANS.