Two Objective Responses Identified at Interim Analysis With CUE-101 in HPV16+ Recurrent/Metastatic HNSCC


CUE-101 could be a potentially promising therapeutic agent for patients with recurrent/metastatic, HPV16-positive head and neck squamous cell carcinoma.

Early findings show CUE-101 and pembrolizumab (Keytruda) yielded 2 partial responses—1 confirmed and 1 unconfirmed—in 4 patients with recurrent/metastatic, human papillomavirus (HPV) 16–positive head and neck squamous cell carcinoma (HNSCC), according to an interim analysis of a phase 1b study (NCT03978689).

Moreover, investigators observed a reduction in target lesions in the 2 remaining patients. Updated findings from the dose expansion cohort examining single agent CUE-101, which treated patients at the recommended phase 2 dose of 4 mg/kg, highlighted a clinical benefit rate of 50%.

The IL-2–targeting agent CUE-101 is being assessed as a potential third-line therapy for patients with HPV-positive HNSCC. CUE-101 is part of a novel class of injectable biologics that are designed to selectively engage and modulate targeted T-cells.

The goal of the multicenter, open label, dose escalation and expansion trial is to examine the safety and tolerability of CUE-101 in patients with recurrent/metastatic disease. Moreover, investigators set out to determine the recommended phase 2 dose, which was found to be 4 mg/kg according to trial findings.

The study has an estimated enrollment of 85 patients. Parts A and B of the study are examining CUE-101 monotherapy and parts C and D will assess the agent alone and in combination with pembrolizumab.

Primary end points for the study include determining any dose limiting toxicities and the secondary end point is overall response rate.

To be eligible for the study, patients needed to be aged 18 years or older with an ECOG performance status of 0 or 1 and a life expectancy of 12 weeks or more. Additionally, patients were required to have progressed on at least 1 prior systemic therapy and undergone treatment with first-line platinum-based chemotherapy or pembrolizumab. Patients with a platelet count of 100x103/µL or higher, a hemoglobin of 9.0 g/dL or higher, or an absolute neutrophil count of 1.5x103/µL or higher were eligible for the study.

Those with active autoimmune disease requiring treatment within the last 2 years, and a history of allogenic bone marrow, stem cell, or solid organ transplant were not eligible for the study. Other exclusion criteria included previous treatment with a systemic anti-neoplastic therapy in the last 2 years, radiation therapy in the last 2 weeks, or treatment with corticosteroids. Patients with clinically significant cardiovascular disease were also not able to enroll.


Cue Biopharma reports two objective responses (1 cPR and 1uPR) in first interim update from dose escalation portion of ongoing phase 1 combination study of CUE-101 and KEYTRUDA® in first line patients with HPV+ recurrent/metastatic head and neck cancer. News release. Cue Biopharma. January 26, 2022. Accessed January 27, 2022.

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