Autolus obe-cel FELIX pooled analysis: 78% CR/CRi, 12-mo EFS 50%, low immunotoxicity; BLA filed for r/r B-ALL

Autolus Therapeutics plc

Pooled FELIX Phase Ib/II (n=127): CR/CRi rate 78%; grade ≥3 CRS 2%, ICANS 7%; median follow-up 16.6 months.
Patients with <5% BM blasts at lymphodepletion: 12-mo EFS 65%, no grade ≥3 CRS or ICANS (n=36).
Pooled ALLCAR19/FELIX Ib (n=36) in r/r B-ALL: 81% remission rate; 41% in ongoing CR at median >3 years follow-up without transplant.
AUTO8 (BCMA/CD19 dual CAR) MCARTY Phase I (n=11): 100% ORR, 7 CR/sCR, no grade ≥3 CRS/ICANS; trial enrolling.
BLA for obe-cel in relapsed/refractory adult B-ALL submitted to FDA; ASH data support regulatory filing.

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