secwatch.observer — SEC 8-K summary
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Issuer:     Autolus Therapeutics plc (AUTL)
CIK:        0001730463
Form:       8-K
Filed at:   2023-12-11T23:59:59+00:00
Accession:  0001730463-23-000119
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1730463/000173046323000119/0001730463-23-000119-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1730463/000173046323000119/autl-20231209.htm
  HTML page:      https://secwatch.observer/filing/0001730463-23-000119

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