CEL-SCI Multikine Phase 3 shows 43% survival extension; BLA submission planned

CEL SCI CORP

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.

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