secwatch.observer — SEC 8-K summary
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Issuer:     CEL SCI CORP (CVM)
CIK:        0000725363
Form:       8-K
Filed at:   2022-08-22T23:59:59+00:00
Accession:  0001654954-22-011627
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

CEL-SCI Phase 3 Multikine shows 14.1% 5-year OS benefit in lower-risk head and neck cancer
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- 8.1% ORR for Multikine+CIZ vs 0% SOC in ITT; 15.2% ORR in proposed indication (n=158).
- 14.1% absolute OS advantage at 5 years in lower-risk arm (62.7% vs 48.6%; HR=0.68).
- Median OS nearly 4 years longer: 101.7 months vs 55.2 months for SOC in proposed indication.
- No excess safety issues; adverse event rates similar across all treatment arms.
- Company plans to submit BLA to FDA for indication covering ~210,000 patients globally.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/725363/000165495422011627/0001654954-22-011627-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/725363/000165495422011627/cvm_8k.htm
  HTML page:      https://secwatch.observer/filing/0001654954-22-011627

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