Regulatory Affairs

FDA lifts clinical hold on study of Multikine for head and neck cancer

PBR Staff Writer Published 16 August 2017

The US Food and Drug Administration (FDA) has lifted the clinical hold it had imposed on the CEL-SCI and Ergomed co-developed Multikine’s phase 3 head and neck cancer study.

Multikine (Leukocyte Interleukin Injection) is being investigated as a potential first-line immunotherapy. Its objective is to harness the immune system of the patient to produce an anti-tumor response.

The phase 3 cancer study features 928 newly diagnosed head and neck cancer patients. CEL-SCI stated that in accordance with the study protocol, all the patients who had finished treatment continue to be followed.

In September last year, the FDA had ordered a partial clinical hold on the trial. Now the FDA has written to CEL-SCI allowing it to resume all clinical trial activities under the Investigational New Drug application (IND) of Multikine.

Ergomed CEO Dan Weng said: "We're very pleased to hear that the Phase 3 study of Multikine in head and neck cancer has been approved for continuation by the FDA.

“Multikine addresses a significant unmet medical need and we look forward to continuing to work with CEL-SCI on what is the largest ever Phase III study in head and neck cancer."

The primary endpoint of the phase 3 trial is an increase by 10% in overall survival for patients who had undergone treatment with Multikine regimen plus standard of care (SOC) against those treated with only SOC.

According to CEL-SCI, the primary end point will be met if there are 298 deaths in total from the two patient arms.

Surgery is the current SOC for head and neck cancer after which radiation therapy alone is given or followed by concurrent radio-chemotherapy.

Multikine was designated as an Orphan Drug by the FDA for neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck (SCCHN).