FDA Registration-Enabling Ph 3 Confirmatory Study of Multikine® launched in Newly Diagnosed Head and Neck Cancer
“Our Confirmatory Registration Study marks a definitive milestone toward establishing Multikine as the new immunotherapy standard of care for newly diagnosed head and neck cancer with low or zero levels of PD-L1,” said Geert Kersten, CEO of CEL-SCI. “Enrollment will span premier clinical centers across the U.S., Europe, Asia, and South America, targeting the exact population where our previous Phase 3 trial demonstrated compelling, statistically significant improvements in overall survival, quality of life, and safety. Backed by approximately 97% statistical power to confirm this survival advantage, we believe this registration-enabling study provides an exceptional opportunity to validate our earlier Phase 3 results and bring this much-needed therapy to patients.”
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