CEL-SCI Reports 14.1% 5-Year Survival Benefit in Phase 3 Multikine Trial; Plans FDA Submission

CEL SCI CORP

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).

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