Cue Biopharma presented updated Phase 1 trial data for its Immuno-STAT biologics, CUE-101 and CUE-102, at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting. The data showcased promising clinical outcomes in patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) and late-stage pancreatic cancer, respectively.
CUE-101 Plus Pembrolizumab in Head and Neck Cancer
The Phase 1 trial evaluated CUE-101, in combination with pembrolizumab (KEYTRUDA®), in first-line HPV+ R/M HNSCC patients. Key findings include a 46% objective response rate (ORR) and a 91.3% 12-month overall survival (OS) rate. The median overall survival (mOS) reached 21.8 months, significantly surpassing the 12.3 months observed in historical data from the KEYNOTE-048 trial, where patients received pembrolizumab alone. Notably, a 50% ORR was observed in patients with low PD-L1 expression (CPS 1-19), a population that typically responds poorly to immunotherapy alone.
Christine H. Chung, M.D., Department Chair, Head and Neck-Endocrine Oncology, Moffitt Cancer Center, and a principal investigator in the CUE-101 trial, stated, "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-101 Monotherapy in Heavily Pretreated HNSCC
In a separate cohort of the Phase 1b trial, CUE-101 was evaluated as a monotherapy in 20 second-line and beyond (2L+) R/M HNSCC patients. The median overall survival (mOS) was 20.8 months, which is notably longer than the historical mOS of 7.5 and 8.4 months reported in the CheckMate 141 and KEYNOTE-040 trials, respectively, for similar patient populations.
CUE-102 in Late-Stage Pancreatic Cancer
The Phase 1 trial of CUE-102, as a monotherapy, included patients with late-stage pancreatic cancer. The data showed a 67% overall disease control rate (DCR) at the 2 and 4mg/kg doses, including an unconfirmed partial response (PR) with a 40% decrease in tumor burden. The study also demonstrated evidence of selective stimulation and expansion of Wilms’ Tumor 1 (WT1)-specific CD8 T cells, without a significant increase in non-specific CD8 T cells.
Safety and Tolerability
Both CUE-101 and CUE-102 were well-tolerated in their respective trials. No significant safety concerns or dose-limiting toxicities (DLTs) were observed, and adverse events were manageable with appropriate medical care.
Immuno-STAT Platform and Future Directions
Cue Biopharma's Immuno-STAT platform is designed to selectively engage and modulate disease-specific T cells. CUE-101 is designed to activate and expand HPV16 tumor-specific T cells, while CUE-102 targets WT1-specific T cells. These results support the potential of the Immuno-STAT platform for treating a variety of cancers.
Matteo Levisetti, M.D., chief medical officer of Cue Biopharma, commented, "The CUE-102 data further demonstrates the mechanism of action of Immuno-STAT biologics to activate and expand tumor-specific T cells, as well as its translation into evidence of clinical benefit. The versatility of the Immuno-STAT platform holds significant potential for treating a variety of cancers."
