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.
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