CEL-SCI Corporation (NYSE American: CVM) has recently shared positive news from its discussion with the U.S. Food and Drug Administration (FDA) regarding the approval pathway for its cancer immunotherapy, Multikine* (Leukocyte Interleukin, Injection), as a first-line treatment. This follows robust safety and efficacy data from CEL-SCI's Phase 3 study on head and neck cancer. As a result, the FDA has allowed CEL-SCI to proceed with a confirmatory Registration Study of Multikine for newly diagnosed advanced primary head and neck cancer patients without lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy).

CEL-SCI, expressed excitement over the outcome, stating, "Through this discussion and agreement with the FDA, we have achieved a tremendous milestone for people who are newly diagnosed with head and neck cancer." He emphasized the clarity and strength of the survival benefit observed in the target patient population, enabling the confirmatory study to enroll only 212 individuals to validate the Phase 3 findings.

Key points from the report include:

• The FDA's approval of a 212-person confirmatory Registration Study underscores the efficacy and safety demonstrated in the previous Phase 3 study involving 928 participants.
• The confirmatory study will employ a randomized controlled trial with two arms: Multikine treatment plus standard of care versus standard of care alone. Notably, Multikine-treated patients in the selected group exhibited a 73% 5-year survival rate, compared to 45% in the control group.
• CEL-SCI's innovative patient selection criteria, developed based on Multikine's biological mechanism of action, garnered FDA acceptance. This allows patient enrollment before surgery, a departure from traditional post-surgery selection practices.
• The FDA's acknowledgment of the high unmet need in the target population and the potential of Multikine to address this need are pivotal factors favoring approval.
• With expert advice affirming a high likelihood of success for the confirmatory study, CEL-SCI's de-risked value proposition offers investors a compelling opportunity in the Phase 3 oncology landscape.

In essence, the FDA's endorsement paves the way for Multikine to potentially redefine the standard of care for newly diagnosed head and neck cancer patients, reflecting CEL-SCI's commitment to advancing innovative therapies to address critical medical needs.

 

Source: businesswire.com

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