Benzinga | Jun 28, 2021 11:09AM EDT

UPDATE: CEL-SCI Earlier Release Showed Co. When Its Multikine Treatment Was Administered And Higher Risk Was Compared To Control, Study Did Not Achieve Its Primary Endpoint

When the complete study population to which the Multikine treatment regimen was administered (i.e., the combined lower risk (no chemotherapy) and higher risk (with chemotherapy added)) was compared to control, the study did not achieve its primary endpoint of a 10% improvement in overall survival. However, the OS benefit of 14.1% at 5 years for the lower risk subgroup (no chemotherapy) exceeded the 10% OS benefit set out for the study population as a whole. In addition, as the OS results for the lower risk of recurrence patients (no chemotherapy) are significant (two-sided p=0.0236, HR=0.68) and the effect is robust, durable and increasing over time, CEL-SCI plans to seek FDA approval for Multikine cancer immunotherapy in this underserved patient population. This indication represents a dire unmet medical need with the last FDA approval being many decades ago. CEL-SCI has Orphan Drug designation from the FDA for the neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck -- the patient population treated in this Phase 3 study.