CEL-SCI’s Multikine® Immunotherapy Misses Primary Endpoint in Phase 3

 

• Data indicate significant overall survival (OS) benefit for patients who received the Multikine® treatment regimen followed by surgery and radiotherapy, but not for patients who had chemotherapy added to the same treatment. The group showing significant survival benefit (no chemotherapy) represents approximately 155,000 patients per year globally, or about 40% of newly diagnosed advanced primary head and neck cancer patients

• Patients treated with the Multikine treatment regimen followed by surgery and radiotherapy(no chemotherapy) demonstrated statistically significant OS (ITT, p=0.0236, HR= 0.68) advantage vs. Standard of Care (SOC) alone; the 3-year survival advantage was 4.9% (72.4% vs 67.5%) and the 5-year survival advantage was 14.1% (62.7% vs 48.6%) for the pre-defined population receiving no chemotherapy.  The Multikine treatment regimen followed by surgery and radiotherapy(no chemotherapy) exhibited consistent OS advantage.  Median follow up time was greater than 7 years for those last alive

• No safety issues were found for Multikine in the treated population

• CEL-SCI plans to seek U.S. Food and Drug Administration (FDA) approval for Multikine immunotherapy based on the demonstrated significant OS benefit and favorable safety profile in the unmet medical need head and neck cancer patients who received Multikine, surgery and radiotherapy as part of their SOC      

• The analysis of this separate group is expected to meet regulatory requirements for FDA submission

• We believe the positive results of the study in this group of patients mark the first-ever success of a neoadjuvant cancer immunotherapy in advanced primary head and neck cancer

https://www.businesswire.com/news/home/20210628005472/en/CEL-SCI%E2%80%99s-Multikine%C2%AE-Immunotherapy-Produces-Significant-14.1-5-Year-Survival-Benefit-62.7-Vs-48.6-in-the-Group-Receiving-Surgery-Plus-Radiotherapy-in-a-Landmark-Head-and-Neck-Cancer-Phase-3-Study