PD-L1 as a biomarker of response to immune-checkpoint inhibitors

Deborah Blythe Doroshow, Sheena Bhalla, Mary Beth Beasley, Lynette M. Sholl, Keith M. Kerr, Sacha Gnjatic, Ignacio I. Wistuba, David L. Rimm, Ming Sound Tsao, Fred R. Hirsch

Research output: Contribution to journalReview articlepeer-review

511 Scopus citations


Immune-checkpoint inhibitors targeting PD-1 or PD-L1 have already substantially improved the outcomes of patients with many types of cancer, although only 20–40% of patients derive benefit from these new therapies. PD-L1, quantified using immunohistochemistry assays, is currently the most widely validated, used and accepted biomarker to guide the selection of patients to receive anti-PD-1 or anti-PD-L1 antibodies. However, many challenges remain in the clinical use of these assays, including the necessity of using different companion diagnostic assays for specific agents, high levels of inter-assay variability in terms of both performance and cut-off points, and a lack of prospective comparisons of how PD-L1+ disease diagnosed using each assay relates to clinical outcomes. In this Review, we describe the current role of PD-L1 immunohistochemistry assays used to inform the selection of patients to receive anti-PD-1 or anti-PD-L1 antibodies, we discuss the various technical and clinical challenges associated with these assays, including regulatory issues, and we provide some perspective on how to optimize PD-L1 as a selection biomarker for the future treatment of patients with solid tumours.

Original languageEnglish (US)
Pages (from-to)345-362
Number of pages18
JournalNature Reviews Clinical Oncology
Issue number6
StatePublished - Jun 2021
Externally publishedYes

ASJC Scopus subject areas

  • Oncology


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