Autolus announces positive primary endpoint data in FELIX trial

Autolus Therapeutic, a clinical-stage biopharmaceutical company, has announced that the phase 2 FELIX clinical trial of obecabtagene autoleucel (obe-cel) in relapsed/refractory (r/r) adult Acute Lymphoblastic Leukaemia (ALL) has met its primary endpoint of overall remission rate (ORR) at interim levels.

Obe-cel (AUTO1), a CD19 CAR T cell investigational therapy, demonstrated an ORR of 70% in an interim analysis of 50 patients. Obe-cel showed comparable expansion and initial persistence (median follow up 6.4 months) to the data showed in the previous ALLCAR19 study.

Within a wider group of 92 patients, only 3% experienced Grade 3 or higher cytokine release syndrome and 8% experienced Grade 3 or higher immune effector cell-associated neurotoxicity syndrome, highlighting encouraging safety data.

By achieving this milestone, Autolus will receive a $35m payment from Blackstone Life Sciences, with a further $35m as a result of the completion of planned activities supporting the obe-cel manufacturing process.

CEO and chair of Syncona Investment Management Limited, Martin Murphy, said: “The data is consistent with what was previously presented in the ALLCAR19 academic study, underlining the potential of obe-cel as a drug which can provide meaningful impact for patients suffering from ALL, whilst also showing a very positive safety profile in the last line setting.”

Associate attending physician at the Memorial Sloan Kettering Cancer Center, Dr Jae Park, said: “Obe-cel’s high level of anti-leukaemia activity, combined with a well-manageable tolerability profile, is a significant step forward in this underserved disease setting, which is characterised by the explosive growth of the leukaemia and the poor condition of many patients.”

James Spargo