secwatch.observer — SEC 8-K summary
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Issuer:     CEL SCI CORP (CVM)
CIK:        0000725363
Form:       8-K
Filed at:   2021-07-07T23:59:59+00:00
Accession:  0001654954-21-007693
Event type: other_material
Sentiment:  positive
Materiality: 0.95
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

CEL-SCI Reports 14.1% 5-Year Survival Benefit in Phase 3 Multikine Trial; Plans FDA Submission
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- Multikine showed a statistically significant 14.1% absolute improvement in 5-year overall survival in patients receiving surgery plus radiotherapy (n=380).
- The successful treatment arm represents 40% of the study population, estimated at 155,000 newly diagnosed advanced head and neck cancer patients annually.
- Analysis of the surgery plus radiation arm was pre-specified in the protocol and statistical analysis plan before unblinding, permitting FDA submission use.
- Company intends to meet with FDA for pre-BLA meeting and file for approval of Multikine in this patient population.
- No safety issues were identified; the survival benefit increased over time with a hazard ratio of 0.68 (p=0.0236).

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/725363/000165495421007693/0001654954-21-007693-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/725363/000165495421007693/cvm_8k.htm
  HTML page:      https://secwatch.observer/filing/0001654954-21-007693

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