CEL-SCI's Multikine(R) 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
9:20 am ET June 28, 2021 (BusinessWire) Print
CEL-SCI Corporation (NYSE American: CVM) today announced results from its 9.5 year pivotal Phase 3 study for its immunotherapy Multikine(R) (Leukocyte Interleukin, Injection)* in the treatment of advanced (stages III and IV) primary (previously untreated) squamous cell carcinoma of the head and neck (SCCHN).
In the intent to treat (ITT) advanced primary SCCHN patients the study showed a statistically significant (p=0.0236, HR=0.68) overall survival benefit of 14.1% with overall survival (OS) of 62.7% at 5 years for the group of patients receiving the Multikine treatment regimen followed by surgery and radiotherapy therapy, but not chemotherapy, as part of their standard of care (SOC) treatment. The OS benefit increased over time. This group represents about 155,000 patients worldwide, or about 40% of all advanced primary head and neck cancer cases annually. Patients treated with the same Multikine treatment regimen prior to surgery and radiotherapy, but who also received chemotherapy, did not exhibit this survival advantage. The chemotherapy, cisplatin, was given intravenously and may have negated the survival benefit imparted by Multikine immunotherapy in these patients.
This global trial enrolled 928 stage III and IVa patients through 78 sites on 3 continents. The ITT population comprised of 923 patients, as 5 randomized patients were never treated. The two main comparator a |
