Cue Biopharma presented updated data from its Phase 1 trials of CUE-101 and CUE-102 at the Society for Immunotherapy of Cancer’s 39th Annual Meeting (SITC 2024), showcasing promising results in head and neck cancer and WT1-positive cancers. The data highlight the potential of these Immuno-STAT biologics to selectively engage and modulate disease-specific T cells, offering new hope for patients with limited treatment options.
CUE-101 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)
In the expansion portion of the Phase 1 trial, CUE-101 at the recommended Phase 2 dose (RP2D) of 4mg/kg in combination with pembrolizumab in first-line HPV+ R/M HNSCC patients demonstrated an objective response rate (ORR) of 46% and an overall disease control rate (DCR) of 75% in patients with combined positive score (CPS) ≥1. This compares favorably to the 19% ORR observed with pembrolizumab alone in the historical KEYNOTE-048 trial. Survival metrics also showed improvement, with a 12-month overall survival (OS) of 91.3% compared to 51% in the KEYNOTE-048 trial, and a median overall survival (mOS) of 21.8 months versus 12.3 months in the historical trial. Notably, an ORR of 50% was observed in patients with PD-L1 CPS 1-19.
As a monotherapy, CUE-101 at the RP2D in second-line and beyond (2L+) patients showed a mOS of 20.8 months, exceeding the historical mOS of 7.5 and 8.4 months reported in the CheckMate 141 and KEYNOTE-040 trials, respectively.
Christine H. Chung, M.D., Department Chair, Head and Neck-Endocrine Oncology, Moffitt Cancer Center, noted, "The therapeutic responses observed with CUE-101 and pembrolizumab are very promising... The latest results highlight the potential of CUE-101 to improve response rates and quality of life for this patient population."
CUE-102 in Late-Stage WT1-Positive Cancers
Data from the completed dose escalation and ongoing dose expansion parts of the Phase 1 clinical trial of CUE-102 showed a 67% overall DCR in late-stage pancreatic cancer patients treated with CUE-102 at 2 and 4mg/kg. This included an unconfirmed partial response (PR) with a 40% decrease in tumor burden. The trial also demonstrated evidence of selective stimulation and expansion of WT1-specific CD8 T cells, without a significant increase in non-specific CD8 T cells. No dose-limiting toxicities were observed during the dose escalation phase at doses ranging from 1-8mg/kg.
About CUE-101 and CUE-102
CUE-101 is designed to activate and expand HPV16 tumor-specific T cells by presenting the HPV E7 protein to the HPV-specific T cell receptor. CUE-102 is designed to activate and expand Wilms’ Tumor 1 (WT1)-specific T cells by presenting the WT1 peptide to the WT1-specific T cell receptor. Both are part of Cue Biopharma’s CUE-100 series of interleukin 2 (IL-2)-based biologics.
Matteo Levisetti, M.D., chief medical officer of Cue Biopharma, stated, “We are pleased with the positive results from both the CUE-101 and CUE-102 ongoing trials as the data continue to mature... The versatility of the Immuno-STAT platform holds significant potential for treating a variety of cancers.”
