CEL-SCI reports new data from Multikine study

CEL-SCI reported new data from its concluded Phase 3 study of Multikine that were presented at the European Society for Medical Oncology, or ESMO, 2024 Congress on Saturday, September 14 in a poster. This data is highly relevant to CEL-SCI’s 212 patient confirmatory registration study which has received the FDA go-ahead and is currently under preparation. As previously reported, CEL-SCI’s completed Phase 3 study of 923 patients showed that newly diagnosed head and neck cancer patients who were deemed at low risk for recurrence after surgery had a median overall survival, or OS, benefit of 46.5-months, almost four-years, over control patients. However, patients who were deemed to be high risk for recurrence after surgery showed no survival benefit. Since the completed Phase 3 study showed clear survival benefit for some, but not all of the patients, the FDA requested that CEL-SCI conduct a confirmatory registration study focusing on the patients who showed the best survival benefit. Based on the data, CEL-SCI determined this target population to be patients with newly diagnosed locally advanced primary head and neck cancer with no lymph node involvement and with low PD-L1 tumor expression. Applying these selection criteria to the completed Phase 3 study of 923 patients resulted in the target population having a 73% survival at five years vs a 45% survival at five years for the control patients, log rank. The hazard ratio was an exceptional 0.34, with a 95% confidence interval upper limit of 0.65 and achieving a 66% reduction in the overall risk of death. The new data presented at ESMO includes a further analysis of the 114 patients in the completed Phase 3 study who met these target population selection criteria and form the basis for the confirmatory study. Specifically, the new analysis focused on those patients who were deemed low risk for recurrence following surgery as opposed to the selected patients who were deemed high risk for recurrence and who were recommended to have chemotherapy added to their treatment following surgery per the same guidelines. While the overall survival benefit was clear and statistically significant for the entire target population, the 79 patients who were recommended to receive only radiotherapy benefited to an even greater degree from pre-surgery treatment with Multikine than the group of 114 as a whole. This target low risk population had a five-year overall survival of 82.6% when treated with Multikine vs. 47.3% when treated with standard of care alone, without overlap in their respective 95% confidence intervals. More recent analysis for the target low risk population showed a hazard ratio of 0.27 achieving a 73% reduction in overall risk of death.