CEL-SCI Shares Head & Neck Cancer Data: Multikine Halves Death Risk

CEL-SCI Corporation has announced that its Chief Scientific Officer, Dr. Eyal Talor, presented significant findings on the company's investigational cancer drug, Multikine, at the International Drug Discovery Science & Technology 20th Annual Congress in Budapest, Hungary, on June 18, 2024. Dr. Talor's presentation, titled "Neoadjuvant Immunotherapy for Head and Neck Cancer: Low Tumor PD-L1 Expression - IT-MATTERS – RCT," highlighted the promising results of Multikine in treating head and neck cancer patients with low levels of tumor cell PD-L1 expression.

Multikine (Leukocyte Interleukin, Injection) is an innovative pre-surgical cancer drug for newly diagnosed, locally advanced resectable head and neck cancer. It has been tested on 750 patients, demonstrating strong safety and efficacy. The drug was found to significantly enhance overall survival in these patients compared to those treated with standard of care therapies alone, especially in those with low tumor cell PD-L1 expression. This contrasts with approved checkpoint inhibitors like Keytruda and Opdivo that show greater survival benefit in patients with higher levels of tumor cell PD-L1 expression. PD-L1, or Programmed Death-Ligand 1, is a protein crucial for immune system regulation and is a target for immune checkpoint inhibitors.

In a randomized, controlled Phase 3 trial, Multikine exhibited a 73% survival rate at five years for patients, compared to a 45% survival rate in the control group. The results were statistically significant with a log rank p-value of 0.0015. The risk of death over five years was halved from 55% in the control group to 27% in the Multikine group, with a hazard ratio of 0.35 (95% confidence intervals [0.19, 0.66]).

Dr. Talor emphasized that the survival benefit observed in this patient population is substantially higher than what will be required for success in a confirmatory study. Based on these compelling results, CEL-SCI is preparing to launch an FDA confirmatory Registration Study for Multikine. This study will enroll 212 newly diagnosed, treatment-naive patients with locally advanced primary squamous cell carcinoma of the head and neck (oral cavity), with no lymph node involvement and low PD-L1 tumor expression. Annually, around 100,000 patients globally meet these diagnostic criteria.

CEL-SCI Corporation, headquartered in Vienna, Virginia, with additional operations near Baltimore, Maryland, aims to enhance patient survival by boosting the immune system while it is still intact. Multikine is designed to target the tumor at an early stage, leveraging the relatively intact immune system to mount a more effective attack against the cancer.

Multikine has received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck. The promising data from the Phase 3 trial has been instrumental in receiving the FDA’s approval to proceed with a smaller, focused confirmatory Registration Study.

The company's approach to cancer treatment with Multikine represents a significant advancement in immuno-oncology, offering hope for improved survival outcomes in patients with specific types of head and neck cancer. CEL-SCI’s focus on enhancing the immune system's ability to fight cancer at an early stage is central to its mission of developing innovative treatments that provide substantial survival benefits.

With the upcoming confirmatory study, CEL-SCI is poised to further validate the efficacy of Multikine, potentially offering a new therapeutic option for patients with head and neck cancer. The company's commitment to advancing cancer treatment through immunotherapy continues to drive its research and development efforts.