CEL-SCI Corporation announced on November 7, 2024, that the U.S. Food and Drug Administration (FDA) agreed on the use of the PD-L1 biomarker to select head and neck cancer patients for the Multikine marketing registration study. This agreement is a crucial step in advancing Multikine's clinical development.
The confirmatory study is specifically designed to enroll newly diagnosed locally advanced primary head and neck cancer patients who present with no lymph node involvement and low PD-L1 tumor expression. This patient population showed a significant survival benefit in Multikine's prior Phase 3 trial.
The FDA's concurrence on these patient selection criteria is vital for the upcoming 212-patient study, which is set to commence in Q1 2025. This clarity helps ensure the trial is focused on the patient group most likely to benefit from Multikine treatment.
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