Multikine - (IT-MATTERS)

July 30, 2026: CEL-SCI Corporation (NYSE: CVM) announced that a manuscript analyzing its Phase 3 IT-MATTERS trial of Multikine (Leukocyte Interleukin, Injection) in newly diagnosed, treatment-naïve, resectable, locally advanced head and neck cancer has been accepted for publication in Oral Oncology. The paper focuses on the prognostic role of tumor PD-L1 expression and reports improved overall survival in a predefined subgroup with low tumor PD-L1 expression and no lymph node involvement who received neoadjuvant Multikine prior to standard of care.

In this subgroup, five-year overall survival was 73% with Multikine plus standard of care versus 45% with standard of care alone; the company also cites an overall survival hazard ratio of 0.34 for the selected population.

CEL-SCI said it will disclose the scientific findings after the article is published per journal policy. The company is preparing to start enrollment in a global 212-patient Confirmatory Registration Study designed to confirm the previously observed overall survival benefit in the same target population, with sites planned across the U.S., Europe, and Asia. Multikine has FDA Orphan Drug designation for neoadjuvant therapy in squamous cell carcinoma of the head and neck and is not yet FDA-approved.