CEL-SCI Corporation (NYSE American: CVM) announced the publication of a study in the peer-reviewed journal Oral Oncology, presenting clinical data on its investigational cancer immunotherapy Multikine in patients with locally advanced resectable oral cancer.

The 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," identifies low and zero tumor PD-L1 expression (TPS below 10%) and the absence of lymph node involvement as biomarkers for selecting patients in future clinical trials.

In the biomarker-selected patient group, those receiving Multikine before surgery followed by standard of care achieved a five-year overall survival rate of 73.4%, compared with 45.8% for patients receiving surgery and standard of care alone. This corresponded to a hazard ratio of 0.34 (p=0.0012), representing a 28.6 percentage point difference. The study also reported a 49% reduction in the risk of disease progression or death, with a progression-free survival hazard ratio of 0.51 (p=0.0197).

CEL-SCI stated it is preparing to begin enrollment in a global 212-patient Confirmatory Registration Study evaluating Multikine in the same patient population. The trial is designed with approximately 97% statistical power.

"Publication of these findings in Oral Oncology represents an important peer-reviewed acceptance of the science behind our Multikine development program," said Geert Kersten, CEO of CEL-SCI.

The published study notes that currently approved checkpoint inhibitor therapies are generally directed toward patients with higher PD-L1 expression. Multikine has not been approved or licensed by the FDA or any other regulatory agency, and its safety or efficacy has not been established for any use. The information in this article is based on a press release issued by CEL-SCI.