secwatch.observer — SEC 8-K summary
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Issuer:     Autolus Therapeutics plc (AUTL)
CIK:        0001730463
Form:       8-K
Filed at:   2024-06-03T23:59:59+00:00
Accession:  0001730463-24-000070
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Autolus presents FELIX update: 78% ORR, 40% ongoing remission without SCT, median OS 23.8 months
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- ORR 78% (99/127); median EFS 11.9 months, median OS 23.8 months; 12-month OS rate 61.1%.
- 40% of responders in ongoing remission without SCT or other therapy at median 21.3 months follow-up.
- Ongoing CAR T persistence associated with 2.7x lower relapse/death risk vs. loss of persistence.
- Consolidative SCT after obe-cel did not appear to improve EFS or OS in responders.
- BLA under FDA review with PDUFA target action date November 16, 2024.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1730463/000173046324000070/0001730463-24-000070-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1730463/000173046324000070/autl-20240531.htm
  HTML page:      https://secwatch.observer/filing/0001730463-24-000070

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer