SUPREME-HN: A retrospective biomarker study assessing the prognostic value of PD-L1 expression in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck

Sara I. Pai, Ezra E.W. Cohen, Derrick Lin, George Fountzilas, Edward S. Kim, Holger Mehlhorn, Neus Baste, Daniel Clayburgh, Loren Lipworth, Carlo Resteghini, Nawar Shara, Takashi Fujii, Jun Zhang, Michael Stokes, Huifen Wang, Philip Twumasi-Ankrah, Sophie Wildsmith, Asud Khaliq, Giovanni Melillo, Norah Shire

Research output: Contribution to journalArticle

Abstract

Background: Programmed cell death ligand-1 (PD-L1) expression on tumor cells (TCs) is associated with improved survival in patients with head and neck squamous cell carcinoma (HNSCC) treated with immunotherapy, although its role as a prognostic factor is controversial. This study investigates whether tumoral expression of PD-L1 is a prognostic marker in patients with recurrent and/or metastatic (R/M) HNSCC treated with standard chemotherapy. Methods: This retrospective, multicenter, noninterventional study assessed PD-L1 expression on archival R/M HNSCC tissue samples using the VENTANA PD-L1 (SP263) Assay. PD-L1 high was defined as PD-L1 staining of ≥ 25% TC, with exploratory scoring at TC ≥ 10% and TC ≥ 50%. The primary objective of this study was to estimate the prognostic value of PD-L1 status in terms of overall survival (OS) in patients with R/M HNSCC. Results: 412 patients (median age, 62.0 years; 79.9% male; 88.2% Caucasian) were included from 19 sites in seven countries. 132 patients (32.0%) had TC ≥ 25% PD-L1 expression; 199 patients (48.3%) and 85 patients (20.6%) had TC ≥ 10% and ≥ 50%, respectively. OS did not differ significantly across PD-L1 expression (at TC ≥ 25% cutoff median OS: 8.2 months vs TC < 25%, 10.1 months, P = 0.55) or the ≥ 10% and ≥ 50% cutoffs (at TC ≥ 10%, median OS: 9.6 months vs TC < 10%, 9.4 months, P = 0.32, and at TC ≥ 50%, median OS 7.9 vs TC < 50%, 10.0 months, P = 0.39, respectively). Conclusions: PD-L1 expression, assessed using the VENTANA PD-L1 (SP263) Assay, was not prognostic of OS in patients with R/M HNSCC treated with standard of care chemotherapies.

Original languageEnglish
Article number429
JournalJournal of Translational Medicine
Volume17
Issue number1
DOIs
Publication statusPublished - Dec 26 2019

Keywords

  • Biomarker
  • Head and neck squamous cell carcinoma
  • Immuno-oncology
  • PD-L1
  • Prognosis
  • Programmed cell death ligand-1

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)

Fingerprint Dive into the research topics of 'SUPREME-HN: A retrospective biomarker study assessing the prognostic value of PD-L1 expression in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck'. Together they form a unique fingerprint.

  • Cite this

    Pai, S. I., Cohen, E. E. W., Lin, D., Fountzilas, G., Kim, E. S., Mehlhorn, H., Baste, N., Clayburgh, D., Lipworth, L., Resteghini, C., Shara, N., Fujii, T., Zhang, J., Stokes, M., Wang, H., Twumasi-Ankrah, P., Wildsmith, S., Khaliq, A., Melillo, G., & Shire, N. (2019). SUPREME-HN: A retrospective biomarker study assessing the prognostic value of PD-L1 expression in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. Journal of Translational Medicine, 17(1), [429]. https://doi.org/10.1186/s12967-019-02182-1