FDA removes clinical hold on CEL-SCI’s Phase III head & neck cancer trial

The last FDA approved treatment for advanced primary head and neck cancer was over 50 years ago.

Multikine is being studied as a potential first-line immunotherapy that is aimed at harnessing the patient’s own immune system to produce an anti-tumour response. Nine hundred twenty-eight newly diagnosed head and neck cancer patients have been enrolled in this Phase III cancer study and all the patients who have completed treatment continue to be followed for protocol-specific outcomes in accordance with the Study Protocol.

The study’s primary endpoint is a 10% increase in overall survival for patients treated with the Multikine treatment regimen plus standard of care (SOC) versus those who receive SOC only. The determination if the study’s primary end point has been met will occur when there are a total of 298 deaths in those two groups. Current SOC for this indication is surgery, followed by radiation therapy alone or followed by concurrent radio-chemotherapy.

There is a clear and unmet medical need for a new treatment in this indication as the last FDA approved treatment for advanced primary head and neck cancer was over 50 years ago. The FDA has also designated Multikine an Orphan Drug for neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck (SCCHN).