CEL-SCI published a release launching a global Phase 3 confirmatory, registration-enabling study of Multikine for newly diagnosed, resectable head and neck cancer.
The trial targets 212 patients with low or zero PD-L1 expression and no clinical lymph node involvement; enrollment is planned across the U.S., Europe, Asia, and later South America.
The study design targets about 97% power to confirm a 0.34 hazard ratio on overall survival; the prior target subgroup showed 73% 5-year survival versus 45%.
Pre-surgical tumor response endpoints may support an FDA accelerated or conditional approval filing while overall survival follow-up continues.
CVM•
