Skip to nav Skip to content

Dr. Chung

Dr. Christine Chung, chair of the Head and Neck Oncology Program at Moffitt Cancer Center, shares her research study investigating the use of CUE-101 in combination with Pembrolizumab to treat first-line HPV 16+ head and neck cancer patients.

CUE-101-0 is a novel biologic, composed of human leukocyte antigen (HLA) complex, HLA-A*0201, a peptide epitope derived from the HPV16 E7 protein, and 4 molecules of reduced affinity human interleukin-2 (IL-2). This biologic is designed to find and activate HPV16-specific CD8+ T cells for the treatment of HPV16+ cancers. This study is the first of its kind in patients with HLA-A*0201 genotype and HPV16+ recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC).

As of July 25, 62 patients have received CUE-101 ranging from 0.06 to 8 mg/kg/dose. Common side effects include fatigue, anemia, chills and hyponatremia. %). In the monotherapy dose escalation portion, a MTD was not identified, and 4 mg/kg was chosen as the RP2D based on PK, PD, and preliminary clinical activity. CUE-101 dose escalation from 1 to 4 mg/kg in combination with pembrolizumab 200 mg has been completed with no DLTs observed and expansion of CUE-101 at 4 mg/kg with pembrolizumab is ongoing. Of the 19 evaluable cohorts treated with CUE-101 monotherapy at the RP2D of 4 mg/kg, the outcomes resulted in 1 patient experienced partial response (PR) and 7 stable disease (SD) for ≥ 12 weeks. Of the 10 evaluable patients treated with CUE-101 plus pembrolizumab, 3 patients experienced PR (2 confirmed) and 2 patients SD for ≥ 12 weeks.

View the full abstract.


If you’d like to refer a patient to Moffitt, complete our online form or contact a physician liaison for assistance. As part of our efforts to shorten referral times as much as possible, online referrals are typically responded to within 24 - 48 hours.