CEL-SCI Presents New Phase 3 Multikine® Data at World Congress: Pre-Surgical Biomarkers Identify Head & Neck Cancer Patients Achieving 73% 5-Year Survival
Target Population Selection: Biomarker profile – applied prior to treatment of locally advanced disease with no lymph node involvement (N0) and low/zero tumor PD-L1 expression (TPS <10%) or zero identifies patients deriving maximum survival benefit from pre-surgical Multikine® treatment.
Nearly 3x Higher Pre-Surgical Response: New analysis demonstrated a statistically significant increase in pre-surgical response/disease downstaging (38% for Multikine + SOC vs. 13% for SOC alone; p = 0.003).
Tumor responses: Significant number of complete and partial tumor responses before surgery.
Substantial Overall Survival Advantage: Biomarker-selected target population demonstrated a 73.4% 5-year survival rate for Multikine-treatment regimen + SOC versus 45.0% for SOC alone, HR = 0.34, p = 0.0012, representing a 66% reduction in the risk of death.
Favorable Safety Profile: In a broader new safety analysis, Multikine regimen demonstrated excellent safety without increasing Grade 3/4 adverse events or systemic toxicity compared to standard of care alone, with no Multikine-related deaths.
Foundation for U.S. Registration Study: Selection criteria form the core of CEL-SCI's upcoming 212-patient U.S. Registration Study, which is designed with about 97% statistical power to prospectively confirm these findings.
Keynote Presentation: Data presented in a Keynote Address by CSO Dr. Eyal Talor at the 6th World Congress on Otology, Rhinology and Laryngology in Rome, Italy.
VIENNA, Va,, October 26, 2026--CEL-SCI Corporation (NYSE American: CVM) today announced positive new pre-surgical tumor response and safety analyses from its completed Phase 3 study of Multikine® (Leukocyte Interleukin, Injection)*. The findings were presented by the Company's Chief Scientific Officer and developer of Multikine, Dr. Eyal Talor, during a keynote address at the 6th World Congress on Otology, Rhinology and Laryngology in Rome, Italy.
The presentation highlights how pre-surgical patient stratification addresses a long-standing limitation in head and neck cancer management, where patient risk assessment traditionally relies on post-operative pathological evaluation.
This precision oncology approach directs immunotherapy to patients most likely to derive clinical benefit prior to surgery, radiation, or chemotherapy and impacts their survival outcome. By evaluating disease characteristics and tumor biomarkers specific to Multikine's mechanism of action, CEL-SCI identified a patient population achieving a 73.4% 5-year overall survival rate with Multikine plus standard of care (SOC) versus 45.0% for SOC alone. These findings serve as the scientific foundation for CEL-SCI's upcoming Phase 3 U.S. Registration Study.