CEL-SCI launches Phase 3 confirmatory trial of Multikine in head and neck cancer

CEL-SCI launched a global Phase 3 confirmatory registration study for Multikine in newly diagnosed, resectable, locally advanced head and neck cancer.

• The trial targets about 212 patients with low or zero PD-L1 expression and no clinical lymph node involvement, based on a high-responder subgroup from its prior Phase 3 study.
• The study design aims for about 97% power to detect a 0.34 hazard ratio on overall survival.
• In the prior Phase 3 subgroup, 5-year overall survival was 73% with Multikine versus 45% with standard of care alone.
• The company plans to use early pre-surgical tumor response endpoints to support potential accelerated or conditional approvals while overall survival follow-up continues.