Data published in peer-reviewed scientific journal Pathology and Oncology Research
Quality of life improvements included reduction in or cessation of pain in the head and neck area, improvement or complete restoration in ability to eat, drink, and swallow, ability for selfcare including walking and using the toilet, and improved emotional wellbeing
Complete responders to Multikine treatment reported a 100% (wherein all respondents scored the highest possible improvement from baseline) on 60% (39/65) quality of life measures
89.4% of partial responders to Multikine reported improved quality of life measures
Multikine is headed into a final confirmatory Registration Study in head and neck cancer
VIENNA, Va., March 24, 2025--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) today announced new data has been published from its prior Phase 3 study of Multikine* (Leukocyte Interleukin, Injection) in newly diagnosed, treatment naïve, resectable, locally advanced head and neck cancer patients in the highly regarded peer reviewed journal Pathology and Oncology Research (POR). The article titled "Neoadjuvant Leukocyte Interleukin Injection Immunotherapy Improves Overall Survival in Low-risk Locally Advanced Head and Neck Squamous Cell Carcinoma -The IT-MATTERS Study" included a comprehensive presentation of results from CEL-SCI’s Phase 3 trial, the largest study ever conducted for newly diagnosed locally advanced head and neck cancer.
"We are pleased that the wealth of data resulting from our completed Phase 3 study is now published in this international oncology journal," stated CEL-SCI’s Chief Scientific Officer, Dr. Eyal Talor. "We believe the marked improvement in quality of life offered by Multikine neoadjuvant treatment appeared to have had a positive impact on patients’ quality of life, and in addition to its favorable safety profile, tolerability and efficacy, it is likely to improve adoption rates for Multikine following regulatory approval."
The new, previously unpublished findings included the following patient quality of life data:
Quality of life (QoL) was assessed and validated through use of two instruments, EORTC QLQ-C30 and EORTC QLQ-H&N 35 across all clinical sites.
EORTC QLQ-C30 is a 30-item questionnaire developed by the European Organisation for Research and Treatment of Cancer (EORTC) to assess the health-related QoL of cancer patients.
EORTC QLQ-H&N 35 is a questionnaire designed to assess the QoL of head and neck cancer patients in conjunction with the general cancer-specific EORTC QLQ-C30.
QoL variables were assessed at baseline, before and after the Multikine treatment, and periodically during long-term follow up. These assessments included questions regarding pain in the mouth, jaw, and throat, problems swallowing, sense of smell and taste, ability for selfcare and mobility including walking, using the toilet, shortness of breath, emotional wellbeing including irritability and depression, and many other daily health assessment factors.
As a neoadjuvant therapy, patients were treated with Multikine before surgery. Pre-surgery objective early response to treatment with Multikine was confirmed by pathology at surgery. There were 45 objective early responders (which included 5 complete responders following 3-weeks of Multikine treatment) in the Multikine treated + standard of care group and zero (none reported by investigators) in the control group, which received the standard of care treatments only (i.e., surgery plus radiotherapy or surgery plus chemoradiotherapy; with cisplatin as the chemotherapeutic agent per the study protocol and NCCN Guidelines).
95.1% of complete responders to Multikine reported improved QoL
Complete responders reported a 100% (wherein all respondents scored the highest possible improvement from baseline) on 60% (39/65) of the QoL measures assessed including sleep, appetite, pain, emotional state, condition of mouth, sense of smell and taste, and social, family and public interactions.
QoL results for complete responders were measured and sustained for over 3 years following treatment with Multikine.
89.4% of partial responders to Multikine (those exhibiting greater than 30% reduction in tumor – confirmed by pathology at surgery) also reported improved assessed QoL measures from baseline.
About the Completed Phase 3 and Upcoming Confirmatory Registration Study
Based on the exceptional efficacy results and favorable safety profile for Multikine in a cohort of patients in the Phase 3 study, the U.S. Food and Drug Administration has given CEL-SCI the go ahead to initiate a confirmatory Registration Study of Multikine in newly diagnosed, previously untreated resectable stage 3 and 4 head and neck cancer patients who had no lymph node involvement and low PD-L1 tumor expression. There is a high unmet need in this patient population, for which no advancement in overall survival has been forthcoming in decades, despite many previous attempts by others.
Upon the Registration Study achieving full enrollment, CEL-SCI plans to seek early approval based on early tumor responses which were shown to correspond with survival rates. During the completed Phase 3 clinical trial, the 5-year overall survival rate of the target patient population (disease stage 3 and 4 patients who had no lymph node involvement and low PD-L1 tumor expression), which is the same population that will participate in the confirmatory study, increased to 73% when patients were treated with Multikine vs 45% for control patients who received only standard of care treatments.
About Pathology and Oncology Research (POR)
A Switzerland-based highly regarded international journal, POR is dedicated to keeping scientists informed of developments in its focused biomedical fields which span the gap between basic research and clinical medicine.
About CEL-SCI Corporation
CEL-SCI believes that boosting a patient’s immune system before surgery, radiotherapy and chemotherapy have damaged it, should provide the greatest possible impact on survival. Multikine is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor.
Multikine (Leukocyte Interleukin, Injection), given right after diagnosis and before surgery, has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Based on the data from the completed randomized controlled Phase 3 study, the FDA concurred with CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a confirmatory Registration Study. The study will enroll 212 newly diagnosed locally advanced primary treatment naïve resectable head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing about 100,000 patients annually.
The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2024. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.
