secwatch.observer — SEC 8-K summary
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Issuer:     DELCATH SYSTEMS, INC. (DCTH)
CIK:        0000872912
Form:       8-K
Filed at:   2024-08-28T23:59:59+00:00
Accession:  0001193125-24-208282
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Delcath reports positive results from two independent studies on CHEMOSAT and HEPZATO KIT in liver cancers
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- CHEMOSAT study: 91% disease control rate, 18.2% complete response in liver tumors; median hepatic PFS 52 weeks overall.
- CHEMOSAT in uveal melanoma: median hepatic PFS 69 weeks; in cholangiocarcinoma: 38 weeks.
- HEPZATO KIT first-line: median OS 22.4 months, hepatic PFS 17.6 months vs 8.8 months for immunotherapy.
- HEPZATO KIT second-line: median PFS 22.2 months; hepatic PFS not reached vs 14.7 months for immunotherapy.
- Both studies published in peer-reviewed journals (ESMO GI and Annals of Surgical Oncology).

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/872912/000119312524208282/0001193125-24-208282-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/872912/000119312524208282/d848260d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-208282

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