FDA Fast Tracks Investigational Drug With or Without Keytruda for Possible Approval for Head and Neck Cancer

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The FDA granted a fast track designation to an investigational drug alone and in combination with Keytruda to treat patients with HPV recurrent/metastatic head and neck squamous cell carcinoma.

The Food and Drug Administration (FDA) granted the investigational drug CUE-101 as a single agent or in combination with Keytruda (pembrolizumab) a fast track designation in patients with HPV recurrent/metastatic head and neck squamous cell carcinoma, according to CUE-101’s manufacturer, Cue Biopharma.

A fast track designation is given by the FDA to a drug that has the potential to treat a serious condition and fill an unmet medical need. In giving the designation, the FDA may expedite the review of the drug for approval and frequently communicate with the manufacturer.

“We are very pleased to have received fast track designation from the FDA for CUE-101,” Dr. Matteo Levisetti, senior vice president of clinical development at Cue Biopharma, said in a press release. “This designation not only underscores the large unmet need for patients with recurrent/metastatic head and neck cancer who currently rely on available non-targeted therapies, but also highlights the potential of CUE-101 to provide a significant clinical benefit.

“To date in its phase 1b clinical trials, CUE-101 has demonstrated a favorable tolerability profile and single-agent anti-tumor activity in monotherapy as well as encouraging anti-tumor clinical activity in combination with (Keytruda), supporting the potential to improve overall survival for these patients.”

Overall survival is an endpoint that investigators evaluate in a clinical trial, and it measures the length of time from first treatment to death from any cause.

The study authors are currently reviewing the safety and efficacy of this investigational drug with or without Keytruda in patients with HPV16-positive recurrent/metastatic head and neck cancer.

Approximately 85 patients are expected to be enrolled onto the trial. The trial is expected to be completed by August 2023. Patients must have a life expectancy of 12 weeks or more, as well as an ECOG performance status of 0 or 1. Of note, an ECOG performance score evaluates a patient’s level of functioning in terms of their ability to care for themselves. A score of 0 or 1 indicates that a patient is either fully active without restriction or is able to participate in minor daily tasks such as house and office work.

Some reasons patients are excluded from enrolling onto the trial include receiving systemic treatment over the past two years for autoimmune diseases such as rheumatoid arthritis, celiac disease and psoriasis. Systemic treatment is treatment that travels throughout a person’s body.

Moreover, patients have been excluded from trial enrollment if they have a history of significant heart disease.

According to a filing on, more than 12 cancer centers across the United States are actively recruiting patients.

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