On April 8, 2025 CEL-SCI Corporation (NYSE American: CVM) reported that a study titled "Distinct CD8+ T cell dynamics associate with response to neoadjuvant cancer immunotherapies" by Li Housaiyin et. al., Cancer Cell (2025) provides support for CEL-SCI’s approach aimed at seeking early regulatory approval for Multikine* (Leukocyte Interleukin, Injection) as a neoadjuvant in the treatment of newly diagnosed previously untreated locally advanced head and neck cancer based on early tumor responses (Press release, Cel-Sci, APR 8, 2025, View Source [SID1234651845]).
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The concept that tumor responses predict survival has been acknowledged for many cancer types and has led to accelerated approval of many cancer drugs. The study in Cancer Cell, which had 41 evaluable patients, gives further support that this is also true in the neoadjuvant pre-surgical immunotherapy treatment of head and neck cancer.
"The data from both our completed Multikine neoadjuvant Phase 3 study and the study published in Cancer Cell show that newly diagnosed locally advanced head and neck cancer patients who were treated with immune therapies before surgery and had tumor responses, were also likely to have better overall survival. This is quite logical—when a person’s tumor shrinks in response to immunotherapy treatment before the tumor is removed by surgery—their survival outcome is expected to be better," stated CEL-SCI CEO Geert Kersten. "We believe that the recent greater availability of peer-reviewed published data specific to neoadjuvant therapy and early tumor response in head and neck cancer supports our development and regulatory efforts."
CEL-SCI’s 212-patient Confirmatory Registration Study, which has received the FDA’s go-ahead, is designed to verify the statistically significant efficacy and safety results from the Company’s previously completed Phase 3 randomized controlled Multikine trial.
During the Multikine Phase 3 clinical trial, the 5-year survival rate of the target patient population for the confirmatory study increased to 73% when patients were treated with Multikine before surgery vs 45% for control patients who received only the standard of care treatments [Log rank p=0.0015 and a hazard ratio of 0.35 (0.18, 0.65; Wald p=0.0012)].
As a neoadjuvant therapy, Multikine is given to patients right after diagnosis, prior to surgery. In the Phase 3 study, pre-surgery objective early tumor response to treatment with Multikine was confirmed by pathology at surgery. There were 45 objective early responders, of which 5 were complete pathological responders, whose tumors completely disappeared in the Multikine treated group, within the 3-weeks of Multikine treatment. There were zero responders reported in the control group pre-surgery. Pre-surgical responders exhibited a 306% overall survival prolongation and had a significantly lowered death rate -vs- non-responders 22.2% vs 54.1% (2-sided Fisher Exact Test, p <0.0001) in support of pre-surgical response being prognostic.