Biomarkers predictive of response to pembrolizumab in head and neck cancer

Background We performed an integrated biomarker evaluation in pembrolizumab‐treated patients with R/M HNSCC enrolled in KEYNOTE‐012 or KEYNOTE‐055. The relationship between biomarkers and HPV status was explored. Methods We evaluated PD‐L1 (combined positive score [CPS]), TMB, T‐cell‐inflamed gene e...

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Published in:Cancer medicine (Malden, MA) MA), 2023-03, Vol.12 (6), p.6603-6614
Main Authors: Pfister, David G., Haddad, Robert I., Worden, Francis P., Weiss, Jared, Mehra, Ranee, Chow, Laura Q. M., Liu, Stephen V., Kang, Hyunseok, Saba, Nabil F., Wirth, Lori J., Sukari, Ammar, Massarelli, Erminia, Ayers, Mark, Albright, Andrew, Webber, Andrea L., Mogg, Robin, Lunceford, Jared, Huang, Lingkang, Cristescu, Razvan, Cheng, Jonathan, Seiwert, Tanguy Y., Bauml, Joshua M.
Format: Article
Language:English
Subjects:
Antineoplastic Agents, Immunological - adverse effects
B7-H1 Antigen
biomarker
Biomarkers
Biomarkers, Tumor - genetics
Cancer therapies
Gene expression
Head & neck cancer
Head and Neck Neoplasms - drug therapy
head and neck squamous cell carcinoma
Human papillomavirus
Humans
Immunohistochemistry
Immunotherapy
Inflammation
Lymphocytes T
Monoclonal antibodies
Mutation
Papillomavirus Infections - complications
Patients
PD-L1 protein
Pembrolizumab
Regression analysis
Squamous cell carcinoma
Squamous Cell Carcinoma of Head and Neck - chemically induced
Squamous Cell Carcinoma of Head and Neck - drug therapy
Statistical analysis
Targeted cancer therapy
tumor microenvironment
tumor mutational burden
Tumors
Viruses
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Summary:Background We performed an integrated biomarker evaluation in pembrolizumab‐treated patients with R/M HNSCC enrolled in KEYNOTE‐012 or KEYNOTE‐055. The relationship between biomarkers and HPV status was explored. Methods We evaluated PD‐L1 (combined positive score [CPS]), TMB, T‐cell‐inflamed gene expression profile (TcellinfGEP), and HPV status. Associations between biomarkers were evaluated by logistic regression (ORR) and Cox regression (PFS, OS). Results Two hundred and fifty‐seven patients (KEYNOTE‐012, n = 106; KEYNOTE‐055, n = 151) had TMB data available; of these, 254 had PD‐L1 and 236 had TcellinfGEP. TMB, PD‐L1, and TcellinfGEP were each significantly associated with ORR (p 
ISSN:2045-7634
2045-7634
DOI:10.1002/cam4.5434