CEL-SCI Presents New Phase 3 Multikine® Data at World Congress: Pre-Surgical Biomarkers Identify Head & Neck Cancer Patients Achieving 73% 5-Year Survival
CEL-SCI presented new biomarker-stratified analyses from its completed Phase 3 Multikine study at the 6th World Congress on Otology, Rhinology and Laryngology in Rome. In the biomarker-selected target population (N0 disease, PD-L1 TPS <10%; n = 114), 5-year overall survival was 73.4% with Multikine plus standard of care versus 45.0% with SOC alone (HR 0.34, p = 0.0012) — a 66% reduction in the risk of death. Pre-surgical response/disease downstaging was 38% versus 13% for SOC (p = 0.003), with no increase in Grade 3/4 adverse events or Multikine-related deaths. These selection criteria form the foundation of an upcoming 212-patient U.S.
Key figures
- Drug Name
- Multikine (Leukocyte Interleukin, Injection)
- Phase Of Trial
- Phase 3
- Hazard ratio
- 0.34 [95% CI: 0.18-0.66], p = 0.0012
- Target subgroup n
- 114
- Death risk reduction
- 66%
- Pre surgical response
- 38% (Multikine + SOC) vs 13% (SOC alone), p = 0.003
- Registration study power
- approximately 97%
- Registration study patients
- 212
- Five year survival biomarker selected
- 73.4% (Multikine + SOC) vs 45.0% (SOC alone)
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