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Autolus' Obe-cel Shows 95.5% Response In Pediatric High-Risk r/r B-ALL With Low Severe CRS And ICANS At ASH 2025

Benzinga·12/08/2025 13:38:02
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  • Obe-cel demonstrates high remission rates in pediatric patients with high-risk r/r B-ALL with overall response rate (ORR) of 95.5%; low rates of high-grade cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) observed, consistent with obe-cel's adult safety profile
  • FELIX study data analyses highlight product cell phenotype and level of CAR T persistence at three months as potential predictors of long-term remission
  • Real-world data independently collected by the ROCCA consortium during the US commercial launch of obe-cel were presented and show a high response rate and low levels of high-grade CRS and ICANS consistent with the clinical trial experience in the FELIX study

LONDON and GAITHERSBURG, Md., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (NASDAQ:AUTL), an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, announces presentation of preliminary data from the CATULUS Phase 1 trial of obe-cel in pediatric relapsed or refractory (r/r) B-ALL patients, as well as further insights from the registrational FELIX study in adult r/r B-ALL, at the American Society of Hematology (ASH) Annual Meeting.