On July 30, 2026 CEL-SCI Corporation (NYSE American: CVM) reported that a manuscript highlighting the latest findings from its Phase 3 study titled "A Novel Neoadjuvant Immunotherapy Confers Improved Overall Survival in Oral Cancer Patients with Low Tumor PD-L1 Expression: The IT-MATTERS Clinical Trial – Prognostic Role of Tumor PD-L1 Expression," has been accepted for publication in Oral Oncology, one of the world’s leading peer-reviewed journals dedicated to head and neck cancer research and treatment.
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The manuscript, authored by Eyal Talor, Ph.D. (CEL-SCI Chief Scientific Officer, the developer of Multikine) and colleagues, is based on data from CEL-SCI’s landmark Phase 3 IT-MATTERS clinical trial evaluating Multikine (Leukocyte Interleukin, Injection)* in the treatment of newly diagnosed treatment naïve, resectable, locally advanced head and neck cancer patients. In accordance with the journal’s publication policies, CEL-SCI will disclose the scientific findings following publication in Oral Oncology.
"The acceptance of this manuscript by Oral Oncology represents another important validation of the quality and significance of our clinical data," said Geert Kersten, CEO of CEL-SCI. "Publication in leading peer-reviewed journals expands awareness of Multikine among oncologists, head and neck surgeons and cancer researchers around the world. As we prepare to begin patient enrollment in our Confirmatory Registration Study, we believe growing recognition within the scientific community will further strengthen the foundation supporting Multikine’s potential to become an important new treatment option for patients with low PD-L1 head and neck cancer."
In CEL-SCI’s Phase 3 study, a well-defined population of newly diagnosed, previously untreated, locally advanced resectable head and neck cancer patients with low tumor PD-L1 expression and no lymph node involvement treated with Multkine before receiving standard of care had a 73% five-year overall survival rate compared to 45% in patients receiving standard of care alone.
Unlike currently available immune checkpoint inhibitor therapies that primarily target patients with higher PD-L1 expression, Multikine is being developed specifically for patients with low PD-L1 tumor expression—an underserved patient population with limited treatment options and a recognized unmet medical need.
CEL-SCI is preparing to commence enrollment in its global 212-patient Confirmatory Registration Study, which is designed to confirm the previously observed overall survival benefit in this predefined target patient population. The registration study aims to enroll patients globally at clinical centers across the United States, Europe and Asia and is designed based on the approximately 97% statistical power to detect the previously observed overall survival hazard ratio of 0.34 in the same selected population of the completed Phase 3 study.
About Multikine
Multikine is a novel cancer immunotherapy administered before surgery as a treatment for newly diagnosed previously untreated locally advanced head and neck cancer. Its goal is to activate a person’s immune system to fight cancer before the ravages of surgery, radiation and chemotherapy have weakened the immune system. In the world’s largest head and neck cancer Phase 3 study in the same selected population, Multikine increased the 5-year survival rate of the target patient population to 73% vs 45% in patients treated with standard of care alone and halved the risk of death from 55% to 27%.
(Press release, Cel-Sci, JUL 30, 2026, View Source [SID1234669555])