other material
confidence high
sentiment positive
materiality 0.80
CEL-SCI Phase 3 Multikine shows 14.1% 5-year OS benefit in lower-risk head and neck cancer
CEL SCI CORP
- 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.