secwatch.observer — SEC 8-K summary
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Issuer:     CEL SCI CORP (CVM)
CIK:        0000725363
Form:       8-K
Filed at:   2023-03-09T23:59:59+00:00
Accession:  0001654954-23-002577
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

CEL-SCI Multikine Phase 3 shows 43% survival extension; BLA submission planned
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- Multikine extended overall survival by 43% (HR 0.70; 95% CI 0.49-1.00) vs SOC in 352 LR head & neck cancer patients.
- 5-year survival: 65.3% Multikine arm vs 49.7% control; benefit increased from 2.8% at 3yr to 15.6% at 5yr.
- 16.5% of Multikine patients had early tumor response (complete pathological) vs 0% control; responders' death rate 15.6% vs 48.7%.
- Data presented at ECHNO 2023; company plans to submit BLA to FDA for newly diagnosed locally advanced SCCHN.
- Intended patient population ~210,000 annual global cases; no new approved therapy for decades.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/725363/000165495423002577/0001654954-23-002577-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/725363/000165495423002577/cvm_8k.htm
  HTML page:      https://secwatch.observer/filing/0001654954-23-002577

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