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Highlights

  • FELIX trial shows 55.4% estimated three-year overall survival in adult r/r B-ALL patients.
  • 40% of patients remain in molecular remission at 36-month follow-up mark.
  • Obe-cel designed for rapid expansion and favorable safety profile in CAR T-cell therapy. 

Autolus Therapeutics plc (NASDAQ:AUTL), a clinical-stage biopharmaceutical company focused on programmed T cell therapies, has announced updated results from its ongoing FELIX trial evaluating obe-cel, an autologous CD19 CAR T-cell therapy, in adults with relapsed or refractory (r/r) CD19-positive B-cell acute lymphoblastic leukemia (B-ALL). 

The FELIX study, a Phase 1b/2 open-label, multicenter, single-arm trial, was designed to assess the safety and efficacy of obe-cel, formerly known as AUTO1. Data presented from the trial revealed an estimated three-year overall survival rate of 55.4%. Additionally, 40% of treated patients remained in molecular remission at the 36-month follow-up point, indicating durable disease control in a significant subset of participants. 

Obe-cel is engineered for rapid CAR T-cell expansion, aiming to improve outcomes while maintaining a favorable safety profile compared to earlier generations of CAR T-cell therapies. The therapy seeks to reduce severe side effects, such as cytokine release syndrome, which can be associated with cellular immunotherapies. 

Dr. Christian Itin, CEO of Autolus, commented on the trial results, stating: 

“Obe-cel’s durability of response without any subsequent therapy in two out of every five responders is a key factor leading the transformation of therapy for adult r/r B-ALL patients. At a median follow-up of 33 months, we are encouraged to see a continuation of the long-term plateau we observed at the last data cut.” 

Beyond obe-cel, Autolus is also developing other cell therapy candidates across multiple oncology indications. Its pipeline includes AUTO1/22 for pediatric ALL, AUTO4 for T-cell lymphoma, AUTO6NG for neuroblastoma, and AUTO8 for multiple myeloma. The company continues to progress clinical development efforts as it evaluates the potential of these therapies to address unmet medical needs in cancer and autoimmune diseases. 

The updated survival and remission data from the FELIX trial provide further insights into obe-cel’s long-term treatment impact and will likely inform Autolus’s ongoing regulatory and commercial planning for its lead program. Investors and stakeholders will be watching closely as the company moves toward potential pivotal studies and regulatory filings.