On September 16, 2024, CEL-SCI reported that its Multikine® has demonstrated a significant improvement in the 5-year survival rate of patients with locally advanced resectable head and neck cancer, achieving an 82.6% survival rate in those treated with surgery and radiation, compared to 47.3% for those receiving standard care.
CEL-SCI Corporation is a biotechnology company, with operations in Vienna, Virginia, and near Baltimore, Maryland. The company is focused on developing immunotherapy treatments designed to harness the body’s immune system to fight cancer and other diseases. Their lead product, Multikine, is aimed at improving survival rates in cancer patients by enhancing the immune system’s ability to target and attack tumors before traditional treatments are applied.
This is the strongest evidence yet of Multikine’s effectiveness, with a 73% reduction in the overall risk of death (hazard ratio of 0.27). These results were observed in patients who met CEL-SCI’s confirmatory Registration Study criteria and were deemed low risk for recurrence, thus not recommended to receive chemotherapy post-surgery per NCCN guidelines.
The data reinforces the idea that improved patient selection, such as through the use of PET scans in the upcoming confirmatory study, could further enhance these outcomes, raising the survival rate from 73% to 82%.
The Phase 3 study, which involved 923 patients, showed that low-risk patients treated with Multikine before surgery had a median survival benefit of almost four years compared to those in the control group. In contrast, high-risk patients, who required chemotherapy after surgery, did not experience the same benefit.
This led the FDA to request a confirmatory Registration Study focusing on patients with low PD-L1 tumor expression and no lymph node involvement, as they showed the best survival rates. The new data, presented at the ESMO 2024 Congress, confirmed that Multikine provided the greatest survival benefit to patients not scheduled to receive chemotherapy.
The additional data presented this weekend at ESMO 2024 provides further evidence that we have identified the target population that has the greatest survival benefit from Multikine, and that our study criteria can select for these patients upon diagnosis, before surgery,”
CEL-SCI CEO Geert Kersten
The findings suggest that more precise diagnostic tools, like PET scans, could help target these patients more effectively, improving survival outcomes even further. Dr. Geert Kersten, CEL-SCI’s CEO, and Dr. Eyal Talor, CSO, both emphasized the importance of these results, indicating that Multikine offers a survival advantage, particularly for patients not subjected to the immune-compromising effects of chemotherapy.
With this new analysis we also saw that patients selected by these criteria who are deemed low risk for recurrence post-surgery have a further improved survival outcome with a hazard ratio of 0.27, which even is better than the already exceptional hazard ratio of 0.34 seen for the overall selected population.”
CEL-SCI’s CSO Eyal Talor, Ph.D.
CEL-SCI’s Multikine Immunotherapy that Targets Tumors Early, Wins FDA Approval
CEL-SCI’s approach is based on the idea that boosting a patient’s immune system while it is still intact can have the greatest impact on survival. Multikine is designed to help the immune system target tumors at a point when it is still strong enough to launch an effective attack.
This therapy, which has been administered to more than 740 patients, has received Orphan Drug designation from the FDA for treating squamous cell carcinoma of the head and neck in the neoadjuvant setting.
The completed Phase 3 study produced very strong data, which led the FDA to approve CEL-SCI’s patient selection criteria for a smaller, targeted confirmatory Registration Study. This study will include 212 patients newly diagnosed with locally advanced head and neck cancer, specifically those without lymph node involvement, as determined by PET scans, and with low PD-L1 tumor expression, verified through biopsy. This group represents over 100,000 patients each year.
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