Early data from a combination of Cue Biopharma’s CUE-101 and Keytruda shows the treatment is effective in patients with recurrent/metastatic HPV16+ head and neck cancer.
Early clinical data from a combination of Cue Biopharma’s interleukin 2 (IL-2)-based biologic, CUE-101 and Merck’s Keytruda shows the treatment is effective in patients with recurrent/metastatic HPV16+ head and neck cancer.
The interim Phase I data were presented at the 37th Annual Society for Immunotherapy of Cancer (SITC) meeting in Boston, M.A.
The combination generated an overall response rate of 40% and a clinical benefit rate of 70% in the first 10 patients, Cue reported. There was also tumor reduction between 35% and 69% in the five patients with partial responses. The median overall survival data in these patients was 50% greater than the current standard of care with anti-PD-1 therapy.
The current standard of care for this indication is Keytruda alone, or in combination with chemotherapy.
The data has put Cue on track to define a potential monotherapy registrational trial by the middle of 2023.
Compared to other IL-2-based therapeutics, CUE-101 harnesses the “natural immunostimulant power of IL-2,” according to the company. The medication is delivered through the use of the HPV antigen and the engineered approach of the IL-2 that activates cytotoxic CD8+ T cells.
Christine Chung, chair of the department of head and neck-endocrine oncology at the Moffitt Cancer Center and principal investigator of the Phase I trial, told BioSpace the early, overall response data has shown potential for CUE-101 to improve upon the standard-of-care treatment for HPV+ head and neck cancer patients.
Because of the high recurrence of disease for this type of cancer, Chung stated there is an urgent need for improved treatment options.
“Many new therapeutic agents with strong scientific rationales don’t always pan out in the clinic. So, when we saw the early efficacy signal with a favorable toxicity profile, I was pleasantly surprised,” Chung said.
In addition to the interim first-line Phase I data, Cue presented long-term data from its Phase Ib monotherapy study of CUE-101 as a third-line treatment in this indication.
The data showed that as a single agent, CUE-101 generated a 42% overall clinical benefit rate, which is 50% greater than the current standard of care for second-line patients.
Beyond CUE-101, the company is also assessing CUE-102, a second IL-2 candidate, as a potential treatment for Wilms’ Tumor 1 positive (WT1+) malignancies. At SITC, Cue shared positive preclinical data regarding the drug’s mechanistic effect in vitro and in vivo.
Anish Suri, the company’s president and chief scientific officer, noted the primary difference between CUE-101 and CUE-102 is in the tumor-specific T-cell epitope. The data shown at SITC demonstrates the “versatility and modularity” of the company’s platform to treat cancer.
“This similarity together with our preclinical data that demonstrated CUE-102’s ability to elicit selective expansion of WT1-specific T cells support our belief for a potential positive tolerability profile and clinical activity,” Suri said in a statement.
He added that Cue looks forward to sharing updated data on this trial in the coming year.
