Cue Biopharma Reports Positive Clinical Update on CUE-101 for Treating HPV-Induced Cancers

Strategic Insights -

Cue Biopharma, a clinical-stage biopharmaceutical company, has reported a significant clinical update on its most advanced asset, CUE-101, which is showing promise in treating HPV-induced cancers. The company announced an additional complete response in a patient with recurrent metastatic HPV+ head and neck squamous cell carcinoma (HNSCC) treated with CUE-101 in combination with pembrolizumab.

Key Takeaways:

  • The complete response was observed in a patient who had durable stable disease for close to two years and demonstrated significant tumor reductions, highlighting the potential of CUE-101 in treating HPV-induced cancers.
  • The patient had multiple sites of disease, including the lungs, which cleared prior to the complete response observed in the target lesion, indicating the selective targeting and modulation of disease-specific T cells by CUE-101.
  • The overall response rate (ORR) of 50% in patients with combined positive score (CPS) greater-than or equal to1, including 50% ORR in patients with low CPS (1-19), is a significant achievement in the treatment of HPV-induced cancers.
  • The 12-month overall survival (OS) of 88% and median overall survival (mOS) of 32 months are favorable survival metrics compared to the historical KEYNOTE-048 trial.
  • The patient's durable disease-free survival is a testament to the prolonged mOS observed in this trial, which is attributed to the repeated stimulation and expansion of tumor-specific T cells by CUE-101.
  • Cue Biopharma's Chief Medical Officer, Matteo Levisetti, highlighted the significance of this patient's response, stating that it demonstrates the differences in timing of clinical activity often observed with immunotherapy compared to traditional cytotoxic therapies.

Statistics:

  • Overall Response Rate (ORR) of 50% in patients with CPS ≥1
  • 50% ORR in patients with low CPS (1-19)
  • 12-month Overall Survival (OS) of 88%
  • Median Overall Survival (mOS) of 32 months
  • 2 CR and 10 partial responses (PR) in patients with CPS ≥1
  • Reduction in the risk of death (HR 0.23) compared to historical data

Sources:

  • Globe News Wire, "Cue Biopharma to Present Clinical Update on CUE-101 for Treating HPV-Induced Cancers"
  • Nasdaq, "Cue Biopharma, Inc. (Nasdaq: CUE) Announces Clinical Update on CUE-101"
  • Cue Biopharma, "Immuno-STAT (R) Platform: A Novel Approach to Treating HPV-Induced Cancers"
  • Globe News Wire, "Cue Biopharma Reports Positive Clinical Update on CUE-101 for Treating HPV-Induced Cancers"