Enhanced neoepitope-specific immunity following neoadjuvant PD-L1 and TGF-b blockade in HPV-unrelated head and neck cancer

Authors

Jason M. Redman, Genitourinary Malignancy Branch, NCI, CCR. NIH, Bethesda, United States of America.
Jay Friedman, Section on Translational Tumor Immunology, National Institute on Deafness a, NIH, Bethesda, United States of America.
Yvette Robbins, Section on Translational Tumor Immunology, National Institute on Deafness a, NIH, Bethesda, United States of America.
Cem Sievers, Section on Translational Tumor Immunology, National Institute on Deafness a, NIH, Bethesda, United States of America.
Xinping Yang, Section on Translational Tumor Immunology, National Institute on Deafness a, NIH, Bethesda, United States of America.
Wiem Lassoued, Tumor Immune Microenvironment Laboratory, Genitourinary Malignancy Branch, NCI, CCR. NIH, Bethesda, United States of America.
Andrew Sinkoe, Genitourinary Malignancy Branch, NCI, CCR. NIH, Bethesda, United States of America.
Antonios Papanicolau-Sengos, Laboratory of Pathology, CCR, NCI, NIH, Bethesda, United States of America.
Chyi-Chia R. Lee, Laboratory of Pathology, CCR, NCI, NIH, Bethesda, United States of America.
Jennifer L. Marte, Genitourinary Malignancies Branch, NCI, CCR. NIH, Bethesda, United States of America.
Evrim B. Turkbey, Radiology and Imaging Sciences, NIH, Bethedsda, United States of America.
Wojciech Mydlarz, Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins School of Medicine, Baltimore, United States of America.
Arjun S. Joshi, Department of Surgery, George Washington University, Washington, DC, United States of America.
Nyall R. London, Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins School of Medicine, Baltimore, United States of America.
Matthew Pierce, Department of Otolaryngology-Head and Neck Surgery, Georgetown University School of Medicine, Washington, DC, United States of America.
Rodney J. Taylor, Department of Otolaryngology-Head and Neck Surgery, University of Maryland School of Medicine, Baltimore, United States of America.
Steven Hong, Department of Otolaryngology-Head and Neck Surgery, Walter Reed Army Medical Center, Bethesda, United States of America.
Andrew Nguyen, ImmunityBio, Culver City, United States of America.
Patrick Soon-Shiong, Advanced Health, ImmunityBio, Culver City, United States of America.
Jeffrey Schlom, Laboratory of Tumor Immunology and Biology, NCI, CCR, NIH, Bethesda, United States of America.
James L. Gulley, Genitourinary Malignancy Branch, NCI, CCR, NIH, Bethesda, United States of America.
Clint T. Allen, Section on Translational Tumor Immunology, National Institute on Deafness a, NIH, Bethesda, United States of America.

Document Type

Journal Article

Publication Date

6-21-2022

Journal

The Journal of clinical investigation

DOI

10.1172/JCI161400

Keywords

Clinical Trials; Immunology; Immunotherapy

Abstract

BACKGROUND: Head and neck squamous cell carcinoma not associated with human papillomavirus (HPV-unrelated HNSCC) is associated with high rates of recurrence and poor survival. METHODS: We conducted a clinical trial in 14 patients with newly diagnosed, HPV-unrelated HNSCC to evaluate the safety and efficacy of neoadjuvant bintrafusp alfa, a bifunctional fusion protein that blocks programmed death-ligand 1 (PD-L1) and neutralizes transforming growth factor-beta (TGF-). RESULTS: Bintrafusp alfa was well tolerated, and no treatment-associated surgical delays or complications occurred. Objective pathologic responses were observed and 12 of 14 patients (86%) were alive and disease free at one year. Alterations in regulatory T cell infiltration and spatial distribution relative to proliferating CD8 T cells indicated reversal of Treg immunosuppression in the primary tumor. Detection of neoepitope-specific tumor T cell responses, but not viral-specific responses, correlated with development of a pathologic response. Detection of neoepitope-specific responses and pathologic responses in tumors was not correlated with genomic features or tumor antigenicity but was associated with reduced pre-treatment myeloid cell tumor infiltration. These results indicate that dual PD-L1 and TGF- blockade can safely enhance tumor antigen-specific immunity and highlight the feasibility of multi-mechanism neoadjuvant immunotherapy in patients with HPV-unrelated HNSCC. CONCLUSION: Our studies provide new insight into the ability of neoadjuvant immunotherapy to induce polyclonal neoadjuvant-specific T cell responses in tumors and suggest that features of the tumor microenvironment, such as myeloid cell infiltration, may be a major determinant of enhanced anti-tumor immunity following such treatment.

Department

Surgery

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