CEL-SCI, FDA agree on patient selection approach for Multikine study

CEL-SCI (CVM) announced that in a recent meeting the FDA concurred with the company’s approach to patient selection using low PD-L1 tumor expression in its confirmatory registration study for Multikine. This study will focus on the treatment of newly diagnosed locally advanced primary head and neck cancer patients with no lymph node involvement and low PD-L1 tumor expression. This registration study, slated to commence in the first quarter of 2025, will enroll approximately 212 patients and prospectively confirm the favorable safety profile and the very favorable efficacy results demonstrated in the target population in CEL-SCI’s prior Phase 3 randomized study of 928 patients.