Cue Biopharma Presents Positive Data Update from Ongoing Phase 1 Trials of CUE-101 for Recurrent/Metastatic HPV+ Head and Neck Squamous Cell Carcinoma at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting
- As of the data cutoff date, nine of the 14 evaluable patients treated with CUE-101+ KEYTRUDA® (pembrolizumab) demonstrated tumor regression, with five confirmed partial responses (PRs) and three durable stable disease (DSD) responses, two of which have tumor burden reductions of -18% and -24% and remain on treatment
- 100% of patients treated with CUE-101+ pembrolizumab at the recommended phase 2 dose (RP2D) of 4mg/kg (n=16) remain alive to date following treatment
- As of the data cutoff date, CUE-101 as monotherapy at the RP2D of 4mg/kg demonstrated median overall survival (mOS) approaching 14 months, in third line and beyond (3L+) patients, ~6 months longer than reported with current standard of care in second line (2L) patients
- Clinical data supports potential registrational paths for both CUE-101 as a monotherapy in 3L+ R/M HPV16+ HNSCC, and CUE-101+ pembrolizumab in first line (1L) R/M HPV16+ HNSCC
“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
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
- 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%
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:
Presenter: Christine Chung, M.D., Moffit Cancer Center
Poster Discussion Session Date and Time:
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
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.
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.
Founded in 1964, the
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.
About Cue Biopharma
Headquartered in Boston, Massachusetts, we are led by an experienced management team and independent Board of Directors with deep expertise in immunology and immuno-oncology as well as the design and clinical development of protein biologics.
For more information please visit www.cuebiopharma.com and follow us on Twitter at https://twitter.com/CueBiopharma.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the safe harbor created by those sections. Such forward-looking statements include, but are not limited to, those regarding: the company’s beliefs about the potential benefits of CUE-101 and the CUE 100 series; the company’s belief that the Immuno-STAT platform stimulates targeted immune modulation through the selective engagement of disease-relevant T cells; and the company’s business strategies, plans and prospects. Forward-looking statements, which are based on certain assumptions and describe the company’s future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “seek,” “intend,” “plan,” “goal,” “project,” “estimate,” “anticipate,” “strategy,” “future,” “likely” or other comparable terms, although not all forward-looking statements contain these identifying words. All statements other than statements of historical facts included in this press release regarding the company’s strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Important factors that could cause the company’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the company’s limited operating history, limited cash and a history of losses; the company’s ability to achieve profitability; potential setbacks in the company’s research and development efforts including negative or inconclusive results from its preclinical studies, its ability to secure required
Senior Director, Corporate Communications
Source: Cue Biopharma, Inc.