On July 14, 2023 CEL-SCI Corporation (NYSE American: CVM) reported that it has concluded a productive meeting with the U.S. Food and Drug Administration (FDA) regarding the path forward for bringing Multikine* (Leukocyte Interleukin, Injection) immunotherapy to market for the treatment of newly diagnosed locally advanced squamous cell carcinoma of the head and neck (SCCHN) (Press release, Cel-Sci, JUL 14, 2023, View Source [SID1234633246]). During the recent meeting, the FDA acknowledged the longstanding need for improved treatments for head and neck cancer.
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CEL-SCI believes the agency was collaborative and positive. Preliminary feedback from the FDA included that the selection criteria developed by CEL-SCI could be used to determine which patients should receive Multikine. Based on the feedback received at this recent meeting, CEL-SCI is preparing additional information about its development plan for the next meeting with the agency.
CEL-SCI is expecting scientific advice meetings with the European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK in the fall of 2023. These are priority markets for CEL-SCI, as Europe has more than twice the number of head and neck cancer cases diagnosed each year as compared to the U.S.
The Company believes that it is even further along the regulatory path in Canada, as Health Canada already advised CEL-SCI earlier this year that it would be appropriate to request advance consideration for approval of Multikine under the Notice of Compliance with Conditions (NOCC) policy. If Health Canada grants the NOCC, then it is possible that CEL-SCI could begin commercialization in Canada as early as 2024.
Geert Kersten, CEO of CEL-SCI stated, "The almost 4-year median survival benefit and complete tumor elimination in some patients in just 3 weeks are very strong indications that we have a drug that can help patients with this horrible cancer. It is also important to note that 15.2% of the patients treated with Multikine exhibited a tumor response in only 3 weeks and patients who have a tumor response have an 82.2% survival at 5-years, compared to 48.6% for the control group. Tumor response has often been used in conditional approvals as an important indicator of the effectiveness of a treatment. A confirmatory clinical trial will be required by the FDA based on the agreed upon selection criteria for patients that will be treated with Multikine as assessed by methods including PET-CT/MRI screening. We will collaborate closely with the FDA to design a clinical protocol that will allow us to generate, as expeditiously as possible, the confirmatory data they require for approval of Multikine. This includes confirming the pre-surgical tumor responses that arise within just weeks of Multikine treatment in the agreed upon population. Our meeting with Health Canada earlier this year was also positive, and we are preparing our application for the NOCC approval as they suggested, which we hope to file later this year/early next year. Our planned meetings with the MHRA in Britain and the EMA in Europe will help us understand if a conditional approval can be given in those countries with a promise to do confirmatory studies after approval or if it is possible to get a conditional approval with the enrollment of just a small number of patients. Our goal is to obtain approval of Multikine worldwide and then make it available to patients as fast as possible."
Multikine is a neoadjuvant immunotherapy given to newly diagnosed head and neck cancer patients for three weeks immediately after diagnosis, before the standard of care (SOC) treatments of surgery and radiation, because that is when the immune system is still thought to be the strongest. The completed pivotal Phase 3 study demonstrated that patients who received Multikine followed by surgery and radiation reported a 5-year statistically significant overall survival (OS) absolute benefit of 14.1% in the intent to treat (ITT) subjects (n=380) who were categorized as lower risk for recurrence (LR) per National Comprehensive Cancer Network (NCCN) guidelines as compared to control LR subjects who received only SOC. With PET-CT/MRI, these subjects can be identified at screening to permit Multikine treatment before surgery.