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CEL-SCI’s Multikine Phase 3 cancer study shows 43% survival extension
The Fly

CEL-SCI’s Multikine Phase 3 cancer study shows 43% survival extension

CEL-SCI Corporation reported new data from its pivotal Phase 3 study, the largest study ever conducted in newly diagnosed locally advanced squamous cell carcinoma of the head and neck, SCCHN. A poster presentation titled "Leukocyte Interleukin Injection immunotherapy followed by radiotherapy extends overall survival n treatment naive locally advanced primary squamous cell carcinoma of the head & neck: the IT-MATTERS Study" was delivered by Eyal Talor, Ph.D., CEL-SCI’s Chief Scientific Officer on March 8 at the 10th European Congress on Head & Neck Oncology in Lisbon, Portugal. CEL-SCI plans to submit a Biologics License Application to the U.S. Food and Drug Administration and other regulatory agencies for approval of Multikine nin the treatment of newly diagnosed SCCHN in patients deemed at lower risk for recurrence as defined by National Comprehensive Cancer Network guidelines, representing a patient population of about 210,000 annual cases globally. The new data presented is very important because it focuses exclusively on the patient population from the IT-MATTERS study for which CEL-SCI is seeking regulatory marketing approval, for locally advanced primary head and neck cancer patients scheduled to receive radiotherapy, but not chemotherapy, after surgery. Per the NCCN guidelines, these LR patients typically are recommended to receive only radiotherapy following surgery. The recommended treatment for higher risk for recurrence patients is concurrent chemoradiotherapy after surgery. In the IT-MATTERS study, 44 patients who were determined to be higher risk for recurrence following surgery should have been administered chemoradiotherapy, but received only radiotherapy, and were included in the survival analysis of the IT-MATTERS study initially performed. A more accurate representation of the survival of the intended LR patient population treated with Multikine would have been obtained had the analysis been performed by excluding these 44 patients. At the ECHNO 2023 Congress, we present study data demonstrating the survival and death rate advantages of the patients treated with Multikine over control in the LR population who received only radiotherapy following surgery.

Published first on TheFly

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