A third-party study published in JAMA Oncology on March 6, 2025, provided data that supports Multikine’s use as a neoadjuvant treatment in patients with tumors having low PD-L1 expression. The study, titled “Neoadjuvant Nivolumab Plus Chemotherapy Followed by Response-Stratified Chemoradiation Therapy in HPV-Negative Head and Neck Cancer: The DEPEND Phase 2 Non-randomized Clinical Trial,” evaluated nivolumab as a neoadjuvant immunotherapy.
The DEPEND study demonstrated that checkpoint inhibitor nivolumab works best in patients with high levels of PD-L1, but does not work well in patients with low or zero levels of PD-L1. These findings are similar to those from CEL-SCI’s Phase 3 study, which showed Multikine worked best in patients with low to zero PD-L1 levels.
This external validation underscores Multikine's potential to address a critical unmet need among newly diagnosed head and neck cancer patients whose tumors have low PD-L1 expression, a population representing about 70% of this patient group. CEL-SCI's upcoming confirmatory Registration Trial will enroll patients based on these criteria.
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