On August 4, 2026 CEL-SCI Corporation (NYSE American: CVM) reported the publication of its study, "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," in the internationally recognized journal Oral Oncology.
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The peer-reviewed publication provides scientific evidence supporting the biomarker strategy that forms the foundation for selecting patients in CEL-SCI’s upcoming global Confirmatory Registration Study of Multikine (Leukocyte Interleukin, Injection)*. The Oral Oncology published study identifies low and zero tumor PD-L1 expression (TPS <10%) and the absence of lymph node involvement (N0) as prognostic biomarkers for selecting patients most likely to achieve substantial survival benefit from Multikine administered before surgery.
In this biomarker-selected patient population, patients receiving the Multikine treatment regimen prior to surgery followed by standard of care achieved a 73.4% five-year overall survival (OS) rate compared with 45.8% for patients receiving surgery followed by standard of care alone, corresponding to a hazard ratio of 0.34 (p=0.0012) and a 28.6% absolute improvement in five-year survival. The published study also demonstrated a statistically significant improvement in progression-free survival (PFS), with a 49% reduction in the risk of disease progression or death (PFS hazard ratio 0.51; p=0.0197) compared to control in the same patient population.
Importantly, the peer-reviewed publication concludes that these biomarkers can be used prospectively to identify patients most likely to benefit from Multikine and guide future clinical studies in head and neck (squamous cell carcinoma) cancer.
"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 results not only confirm the remarkable overall and progression free survival benefit observed in the selected population analyzed in our Phase 3 trial, but they also provide strong support for the biomarker selection strategy we are implementing for our Confirmatory Registration Study. It is important to note that when Keytruda was approved by the FDA in the same indication, based on event free survival, it had not established overall survival benefit. As awareness of the Multikine data grows within the global oncology community, we believe Multikine will become increasingly recognized as a differentiated immunotherapy."
The publication in Oral Oncology notes that currently approved checkpoint inhibitor therapies are generally directed toward patients with higher PD-L1 expression, while Multikine’s unique mechanism of action enables it to benefit patients whose tumors express low (TPS <10%), as well as zero (0%) PD-L1. This creates the potential for a treatment approach that specifically targets the underserved low and zero PD-L1 patient population.
CEL-SCI is preparing to commence enrollment in its global 212-patient Confirmatory Registration Study, which will evaluate Multikine in newly diagnosed, previously untreated, locally advanced resectable head and neck oral cancer patients with low and zero (TPS <10%) PD-L1 tumor expression and no lymph node involvement—the same patient population reported on in the newly published study in Oral Oncology. The trial is designed with approximately 97% statistical power to confirm the previously observed overall survival benefit.
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, 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, AUG 4, 2026, View Source [SID1234669678])