CEL-SCI: Multikine Boosts Quality of Life by Up to 95% in Head & Neck Cancer Patients
CEL-SCI Corporation (NYSE American: CVM) has recently announced the publication of new data from its Phase 3 study of Multikine* (Leukocyte Interleukin, Injection) in the well-respected, 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,” presents comprehensive findings from CEL-SCI’s extensive Phase 3 trial, which is the largest study ever conducted for newly diagnosed locally advanced head and neck cancer.
Study Overview
The Phase 3 trial investigated the efficacy and safety of Multikine as a neoadjuvant therapy for patients newly diagnosed with treatment-naïve, resectable, locally advanced head and neck squamous cell carcinoma (HNSCC). The treatment was administered prior to standard-of-care interventions such as surgery, radiotherapy, or chemoradiotherapy. The primary objective was to evaluate the impact of Multikine on patient outcomes, including overall survival and quality of life (QoL).
Dr. Eyal Talor, CEL-SCI’s Chief Scientific Officer, emphasized the importance of this publication, stating, “We are pleased that the wealth of data resulting from our completed Phase 3 study is now published in this international oncology journal. 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.”
Quality of Life Data from the Study
One of the most striking findings from the study was the improvement in QoL for patients treated with Multikine. This assessment was conducted using validated tools developed by the European Organisation for Research and Treatment of Cancer (EORTC):
- EORTC QLQ-C30: A 30-item questionnaire used to assess the health-related QoL of cancer patients.
- EORTC QLQ-H&N 35: A specialized questionnaire designed to evaluate QoL in head and neck cancer patients, complementing the general EORTC QLQ-C30 assessment.
QoL variables were assessed at multiple time points, including baseline (before treatment), after treatment, and during long-term follow-up. These evaluations covered a wide range of factors, such as:
- Pain levels in the mouth, jaw, and throat
- Swallowing difficulties
- Changes in the sense of smell and taste
- Ability to perform self-care and mobility tasks
- Emotional well-being, including irritability and depression
- Overall social and family interactions
Objective Early Response to Multikine Treatment
In this study, Multikine was administered as a neoadjuvant therapy before surgery. The early response to treatment was confirmed through pathology at the time of surgery. Key findings included:
- 45 patients in the Multikine-treated group showed an objective early response to treatment
- This included 5 complete responders, meaning their tumors completely disappeared after just three weeks of Multikine therapy.
- Zero patients in the control group (who received standard-of-care treatments only) exhibited an objective early response to treatment
- Standard-of-care treatments included surgery plus radiotherapy or surgery plus chemoradiotherapy, with cisplatin used as the chemotherapeutic agent per study protocol and NCCN guidelines.
Quality of Life Improvements in Responders
The study demonstrated significant QoL improvements in both complete and partial responders to Multikine treatment:
- 95.1% of complete responders reported an improvement in QoL
- These patients reported a 100% improvement (i.e., the highest possible improvement score from baseline) in 60% (39 out of 65) of QoL measures assessed.
- Improvements were observed in aspects such as sleep, appetite, pain levels, emotional state, oral health, sense of smell and taste, and social and public interactions.
- These QoL benefits were sustained for over three years following Multikine treatment.
- 89.4% of partial responders (those experiencing a greater than 30% tumor reduction, confirmed by pathology at surgery) also reported notable QoL improvements from baseline assessments.
Implications for Future Treatment Approaches
The results of this Phase 3 trial highlight the potential of Multikine as an effective neoadjuvant immunotherapy for head and neck cancer. The substantial improvements in patient QoL, along with the favorable safety and efficacy profiles, suggest that Multikine could become an important addition to the standard-of-care treatment paradigm once it receives regulatory approval.
Given that head and neck cancer treatments can often lead to severe side effects impacting basic functions such as eating, speaking, and social interactions, the ability of Multikine to significantly improve QoL represents a major advancement in patient care. The findings from this study could potentially drive wider adoption of Multikine and influence future clinical guidelines for managing head and neck cancer.
