CEL-SCI Corporation (NYSE American: CVM) today highlighted the promising implications for its immunotherapy Multikine® (Leukocyte Interleukin, Injection) following a recent meeting of the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC), which serves as a public forum for discussion.
FDA advisory committees provide independent expert guidance on the safety and effectiveness of both new and existing drugs, assisting the FDA in making informed decisions. While their recommendations are generally followed, they are non-binding.
At the recent ODAC meeting on September 27, 2024, the committee assessed the use of checkpoint inhibitors for various cancers. PD-L1 is the primary biomarker used for selecting patients for these drugs, which include popular treatments like Keytruda and Opdivo. The FDA sought input on:
- The adequacy of PD-L1 expression as a predictive biomarker for patient selection.
- Risk-benefit assessments for different subpopulations based on PD-L1 expression.
- The sufficiency of data to justify restricting approvals of immune checkpoint inhibitors based on PD-L1 levels.
After reviewing peer-reviewed data, the panel voted 10-2 and 11-1 against the risk-benefit profiles of PD-L1 inhibitors for various cancers. Concerns were raised about the lack of benefit for patients with low PD-L1 expression, along with potential unnecessary toxicities and increased financial burdens.
Checkpoint inhibitors represented an estimated $48 billion global market in 2023, with PD-L1 inhibitors accounting for 73% of this market. Current approvals for these drugs cover all patients, regardless of PD-L1 expression.
“The advisory committee’s findings mark a pivotal moment in cancer treatment, highlighting a significant gap for patients with low or negative PD-L1 levels. While leading checkpoint inhibitors like Keytruda work well for high PD-L1 expressers, Multikine is uniquely designed to benefit low and negative PD-L1 patients. Our previous studies identified low PD-L1 expression as a key biomarker, relevant to about 70% of head and neck cancer patients. This will inform our upcoming FDA confirmatory Registration Study for Multikine in treating treatment-naïve, resectable locally advanced head and neck cancer,” stated CEL-SCI CEO Geert Kersten.
“ODAC’s decision reinforces our belief in Multikine’s potential across a broader range of solid tumor indications, both alone and in combination treatments,” Kersten concluded.
About CEL-SCI Corporation
CEL-SCI is focused on enhancing patients’ immune systems while still intact, aiming to maximize survival impact. Multikine is engineered to enable the immune system to target tumors effectively at this critical time.
Multikine (Leukocyte Interleukin, Injection), a first-line cancer therapy, has been administered to over 740 patients and has received Orphan Drug designation from the FDA for neoadjuvant therapy in squamous cell carcinoma of the head and neck. Following strong results from a Phase 3 study, the FDA approved CEL-SCI’s targeted patient criteria for a focused confirmatory Registration Study, which will enroll 212 patients. This study will target newly diagnosed locally advanced primary head and neck cancer patients with low PD-L1 expression, representing over 100,000 annual cases.
The company operates in Vienna, Virginia, and the Baltimore, Maryland area.
