SITC 2022: Early evidence of clinical benefit from Cue’s IL-2-based therapeutic with KEYTRUDA

By Jane Byrne

- Last updated on GMT

© GettyImages/Design Cells
© GettyImages/Design Cells

Related tags interleukin squamous cell carcinoma Keytruda

Cue Biopharma has released positive data at SITC 2022 from its ongoing Phase 1 trial evaluating its lead interleukin 2 (IL-2)-based biologic, CUE-101, in combination with KEYTRUDA, as a first line therapy for patients with recurrent/metastatic HPV+ head and neck squamous cell carcinoma (HNSCC).

The company, which is developing a class of injectable biologics to selectively engage and modulate tumor-specific T cells directly within a patient’s body, also provided an update from its ongoing fully enrolled Phase 1b trial evaluating CUE-101 monotherapy as third line and beyond therapy in the same patient population at the event.

The Society for Immunotherapy of Cancer’s 37th Annual Meeting (SITC 2022) was held virtually and in Boston during 8-12 November.

The developer says that, unlike other IL-2-based therapeutics in development, CUE-101 leverages the natural immunostimulant power of IL-2 but delivers it only to tumor-specific ‘cancer-killing’ T cells to trigger a targeted antitumor effect, to maximize therapeutic benefit while avoiding the negative side effects of global systemic immune activation. This is done through the presentation of two signals or ‘cues’ to T-cells receptors: Signal #1 is the HPV antigen and Signal #2 is an engineered IL-2 version.

The key findings from the two SITC 2022 poster presentation​ included:

  • An overall response rate (ORR) of 40% and a clinical benefit rate (CBR) of 70% ​was observed to date in first line (1L) recurrent/metastatic HNSCC patients treated with CUE-101 at the recommended Phase 2 dose and pembrolizumab (KEYTRUDA).
  • Median overall survival (mOS) approaching greater than 12 months was seen in third line and beyond (3L+) patients treated to date with CUE-101 monotherapy, which the company said is 50% greater than current standard of care (SOC) with anti-PD-1 therapies in second line (2L) patients.

Ken Pienta, acting chief medical officer of Cue Biopharma, said the new data from its combination study demonstrates early evidence of complementary mechanistic activity of CUE-101 with KEYTRUDA.

Single agent 

“In addition, the sustained clinical benefit rate with CUE-101 as monotherapy is very encouraging and has continued to demonstrate proof-of-concept of CUE-101 as a single agent. Overall, the data shows the potential of CUE-101 to provide patients with an improved clinical benefit rate and with lower toxicity than current standard of care."

The developer will continue to evaluate data from the trial. In addition, he said it will look to define the potential registrational trial for CUE-101, potentially mid-2023.

"There is an urgent need for more effective and durable treatment options with less side effects as more than half of all patients with recurrent/metastatic HNSCC given the current standard of care will experience disease progression,"​ noted Dr Christine Chung, chair, Department of Head and Neck-Endocrine Oncology, Moffitt Cancer Center, and a principal investigator participating in the CUE-101 clinical trial. “We are very encouraged with the overall response rate observed in the trial so far with CUE-101, and its potential to improve standard of care for HPV+ head and neck cancer patients."

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