CEL-SCI Corporation (CVM), a leader in immunotherapy, announced FDA approval of its patient selection strategy for the upcoming confirmatory Registration Study of Multikine® (Leukocyte Interleukin, Injection).
This approval is a significant milestone for CEL-SCI, as the study will target newly diagnosed, locally advanced head and neck cancer patients with low PD-L1 tumor expression (TPS <10) and no lymph node involvement.
Starting in early 2025, the study plans to enroll 212 patients to confirm safety and efficacy shown in CEL-SCI’s previous Phase 3 study of 928 patients.
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Multikine Aims at Low PD-L1 Patients in the $48 Billion Cancer Therapy Market
PD-L1 is a key cancer biomarker, especially for checkpoint inhibitors like Keytruda and Opdivo, effective in high PD-L1 patients.
CEL-SCI’s Multikine, however, shows better efficacy for low PD-L1 patients, representing about 70% of head and neck cancer cases.
Unlike traditional checkpoint inhibitors that release immune “brakes,” Multikine activates immune responses in low PD-L1 patients, filling a market gap.
“Multikine is the only neoadjuvant immunotherapy known to show survival benefits in low and negative PD-L1 head and neck cancer patients,” said CEL-SCI CEO Geert Kersten.
“The FDA’s agreement on patient selection based on low PD-L1 levels strengthens our approach and boosts our confidence in Multikine’s potential for this targeted population.”
Addressing an Unmet Need in Head and Neck Cancer Treatment
Multikine’s approach targets early-stage, resectable head and neck cancer patients with low PD-L1, about 100,000 cases annually.
This aligns with CEL-SCI’s mission to treat cancer patients less responsive to checkpoint inhibitors, filling a critical therapy gap.
About CEL-SCI and Multikine’s Potential Impact on Cancer Immunotherapy
CEL-SCI’s Multikine (Leukocyte Interleukin, Injection) is a pioneering first-line cancer therapy. Dosed in over 740 patients, Multikine received FDA Orphan Drug designation for neoadjuvant use in head and neck cancer.
Backed by Phase 3 data, the FDA’s endorsement further validates Multikine’s potential in cancer treatment.
The upcoming Registration Study aims to position Multikine as a leading treatment for low PD-L1 head and neck cancer patients, advancing CEL-SCI’s mission in cancer immunotherapy.
CEL-SCI Prepares for 2025 Launch of Pivotal Multikine Study
Supported by the FDA and a targeted patient strategy, CEL-SCI will launch its Multikine Registration Study in Q1 2025.
By focusing on low PD-L1 patients, CEL-SCI aims to address a critical gap in head and neck cancer treatment, positioning Multikine for a transformative role in future cancer care.
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