CEL-SCI reports 73.4% five-year survival in Multikine Phase 3 patient analysis

he findings were presented by CEL-SCI Chief Scientific Officer and Multikine developer Dr. Eyal Talor during a keynote address at the 6th World Congress on Otology, Rhinology and Laryngology in Rome, Italy.

The analysis focused on pre-surgical patient stratification, an approach intended to identify patients most likely to benefit from immunotherapy before undergoing surgery, radiation or chemotherapy. Traditionally, risk assessment in head and neck cancer has relied heavily on pathological findings obtained after surgery, potentially limiting opportunities to tailor treatment earlier in the care pathway.

By examining disease characteristics and pre-treatment tumor biomarkers associated with Multikine’s mechanism of action, CEL-SCI identified a subgroup of patients who achieved a 73.4% five-year overall survival rate when treated with Multikine followed by standard of care. This compared with 45.0% among patients receiving standard of care alone.

The company said the findings provide a scientific basis for its planned Phase 3 U.S. registration study, which will focus on the patient population identified through the analysis.

Kersten said the combination of disease stage and pre-treatment tumor biomarkers could help identify patients who experience a substantial survival benefit when Multikine is administered before surgery. He also highlighted findings indicating that nearly three times as many patients treated with Multikine achieved disease downstaging compared with the control group, alongside evidence of pre-surgical tumor shrinkage.

According to CEL-SCI, these treatment effects were observed without adding toxicity to standard-of-care treatments, an important consideration as the company evaluates Multikine’s potential role in cancer treatment.

The company also pointed to Multikine’s safety profile as a potential differentiator from immune checkpoint inhibitors, some of which carry boxed warnings for serious or potentially fatal immune-related adverse events affecting specific organs.

CEL-SCI is now looking to build on the Phase 3 findings through its planned U.S. registration study, with the goal of further evaluating Multikine in a biomarker-defined patient population and advancing the investigational therapy toward potential commercialization.

The reported survival and tumor-response findings are based on the company’s analysis of its completed study; the planned registration study will be important in determining whether these results can be confirmed.

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