Chris Wack’s Contribution After the business revealed findings from its nine-and-a-half-year pivotal Phase 3 research for its immunotherapy Multikine leukocyte interleukin injection in the treatment of advanced primary squamous cell carcinoma of the head and neck, CEL-SCI Corp. shares fell 28 percent to $18 on Monday.
According to the company, a study of patients with advanced primary squamous cell carcinoma of the head and neck found a statistically significant overall survival benefit of 14.1%, with overall survival of 62.7 percent at five years for the group of patients who received the Multikine treatment regimen followed by surgery and radiotherapy therapy, but not chemotherapy, as part of a five-year treatment plan. According to the report, the OS benefit grew over time. This survival advantage was not seen in patients who got the same Multikine treatment regimen prior to surgery and radiotherapy but also received chemotherapy. The intravenous chemotherapy, cisplatin, may have reversed the survival benefit conferred by Multikine immunotherapy in these patients. The trial involved 928 patients in stages III and IVa across 78 sites on three continents. Because five randomized patients were never treated, the ITT population consisted of 923 patients. The Multikine therapy regimen + SOC versus SOC alone were the study’s two main comparator arms. At five years, patients who received the Multikine therapy regimen + SOC compared to SOC alone had an overall survival benefit of 14.1%, which was higher than the pre-defined 10% overall survival benefit for the research population as a whole. The overall survival advantage grew with time and was visible for this group of patients from the beginning of the trial to the end of the follow-up period, with a median follow-up time of more than seven years for those still alive. In the whole treated patient group, no safety issues with Multikine were discovered during or as a result of its administration, including no late effects, according to the company. Chris Wack can be reached at chris.wack@wsj.com.
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