On July 26, 2024 CEL-SCI Corporation (NYSE American: CVM) reported positive results from a bias analysis conducted for its concluded Phase 3 study of Multikine (Leukocyte Interleukin, Injection)* in the treatment of head and neck cancer (Press release, Cel-Sci, JUL 26, 2024, View Source [SID1234645107]). Conducting a bias analysis is a standard process used to identify, assess, and address potential sources of bias that could influence the outcomes and interpretations of study results. The goal of a bias analysis is to ensure that the trial’s findings are reliable, the conclusions are valid, and to minimize the risk that bias has distorted the results.
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CEL-SCI’s bias analysis concluded that the treatment group demographics and baseline characteristics were comparable for the Multikine treated and control arms of the Phase 3 study. There were no confounding baseline parameters in the Multikine-treated versus control population. No bias was present in the study and none was detected in favor of the investigational product, Multikine. As such, the study data are reliably interpretable, statistically significant and have been shown to support the clinical effect of neoadjuvant (pre-surgery) Multikine immunotherapy in extending the life of these patients in the Phase 3 study.
This is critically important information because CEL-SCI, with the FDA’s agreement, will be conducting a 212-patient confirmatory registration study for Multikine. The target population for the confirmatory study shows a 5-year survival in advanced primary head and neck cancer of 73% in Multikine treated patients vs. 45% survival in the control.
"Multikine’s efficacy results in the target population are truly impressive and the bias analysis is critical to demonstrate a high degree of confidence in the data. A hazard ratio of 0.35 with an upper limit of 0.66 is excellent and suggests a very high chance to repeat the great survival benefit from Multikine. The bias analysis showed that the survival benefit is truly from Multikine as opposed to an imbalance in the patient population," stated CEL-SCI CEO Geert Kersten. "We are pleased to share the baseline results as we prepare to submit the data to regulators ahead of our upcoming confirmatory registration study."
The bias analysis was conducted for the entire Phase 3 study population of 923 patients with newly diagnosed resectable, locally advanced primary head and neck cancer, as well as the subgroup of 114 patients who had no lymph node involvement and had low PD-L1 tumor expression (determined via biopsy), the target population for CEL-SCI’s upcoming confirmatory registration study.