On May 25, 2023 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body, reported the presentation of a positive data update from its ongoing Phase 1 clinical trials evaluating its lead biologic from the IL-2-based CUE-100 series, CUE-101, for the treatment of patients with human papilloma virus (HPV16+) recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) as a monotherapy and in combination with pembrolizumab (Press release, Cue Biopharma, MAY 25, 2023, View Source [SID1234632092]). The data will be presented in a poster by Dr. Christine Chung, M.D., Chair, Department of Head and Neck-Endocrine Oncology, Moffitt Cancer Center on June 5, 2023 at the ASCO (Free ASCO Whitepaper) Annual Meeting in Chicago, IL. In addition, the poster will also be highlighted by an expert head and neck cancer panel during a Poster Discussion Session immediately following the scheduled poster presentation.
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"CUE-101 clinical data to date continues to demonstrate both promising evidence of single-agent activity as well as complementary activity in combination with checkpoint inhibitor pembrolizumab." said Matteo Levisetti, M.D., chief medical officer of Cue Biopharma. "Based on the strength of the data to date, we believe CUE-101 has the promise to be a potential therapeutic advancement for patients battling head and neck cancer, a devastating disease of unmet medical need, with potential registrational paths both as monotherapy and in combination with pembrolizumab."
Key data highlights from the Phase 1b trial in combination with pembrolizumab at the RP2D of 4mg/kg, with 14 evaluable patients as of the data cutoff date of May 15, 2023 include:
Overall response rate of ~40% with 4 out of 5 confirmed PRs occurring in tumors with low PD-L1 expression as evidenced by combined positive scores (CPS) of 20 or less
Importantly, all 5 patients with a confirmed PR demonstrated >99% reduction in circulating cell-free HPV DNA (HPV cfDNA)
Median duration of response is 35 weeks with a median progression free survival (PFS) approaching 5 months
Key data highlights from the Phase 1b CUE-101 monotherapy patient expansion portion of the trial at the RP2D of 4mg/kg to date, include:
Current mOS approaching 14 months compares favorably to the historical mOS of 7.5 and 8.4 months reported from third-party clinical trials with checkpoint inhibitors in 2L R/M HNSCC in CheckMate 1411 and KEYNOTE-040 respectively2
CUE-101 has been well tolerated to date as monotherapy and in combination with pembrolizumab
Durable PR greater than 9 months and 6 DSD including a patient remaining on therapy for ~2 years, resulting in an overall clinical benefit rate of 35%
Dan Passeri, chief executive officer of Cue Biopharma, added, "Overall, the emerging data supports the potential of CUE-101 to provide patients with an enhanced disease control rate. We look forward to continuing to evaluate responses in these patients in addition to assessing the registrational trial options for CUE-101. Furthermore, the observed evidence of single agent activity in late-stage patients and the complementary mechanism of action in combination with checkpoint inhibition holds the potential to enhance anti-tumor activity across a broad range of cancers with our Immuno-STAT platform."
Presentation Details
Title: A phase 1 dose-escalation and expansion study of CUE-101, a novel HPV16 E7-pHLA-IL2-Fc fusion protein, given as monotherapy and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck cancer.
Abstract Number: 6013
Session: Head and Neck Cancer
Poster Session Display Date and Time: June 5, 2023, 1:15 PM-4:15 PM CDT
Presenter: Christine Chung, M.D., Moffit Cancer Center
Poster Discussion Session Date and Time: June 5, 2023, 4:30 PM-6:00 PM CDT
Discussant: Erminia Massarelli, M.D., Ph.D., City of Hope Comprehensive Cancer Center
The poster will be available in the Investor & Media section of the Company’s website at www.cuebiopharma.com under Scientific Publications and Presentations, following the presentation.
The Company will host an Investor Update call on Wednesday, June 14, 2023 to review and discuss the clinical progress and associated data presented at ASCO (Free ASCO Whitepaper) on June 5. Call details will be issued prior to the event.
References:
1. Ferris, R.L. (Oct 2016) Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck (CheckMate-141): a randomized, open-label, phase 3 study. The New England Journal of Medicine 2016; 375:1856-67.DOI: 10.1056/NEJMoa1602252
2. Cohen, EW E. (Nov 2018) Pembrolizumab versus methotrexate, docetaxel, or cetuximab for recurrent or metastatic head-and-neck squamous cell carcinoma (KEYNOTE-040): a randomized, open-label, phase 3 study. The Lancet, DOI: View Source(18)31999-8
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About HPV+ Recurrent or Metastatic Head and Neck Cancer
Head and neck squamous cell carcinomas (HNSCC) are the 8th most common cancer in the world. A significant subset of the cases of HNSCC includes human papillomavirus (HPV) associated oropharyngeal tumors, with HPV16 detectable in 80%-90% of these cases. Despite the current standard of care treatments, more than 50% of patients with advanced HNSCC will experience recurrence, representing a significant unmet need.
About the CUE-100 Series
The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-MHC (pMHC) molecules along with rationally engineered IL-2 molecules. This singular biologic is anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient’s body. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing the potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies.