Drugs of interest to pathologists
Drugs related to surgical pathology

Deputy Editor-in-Chief: Debra L. Zynger, M.D.
Him G. Kwee, M.D.

Topic Completed: 1 March 2018

Minor changes: 11 December 2020

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PubMed Search: Durvalumab AND (free full text[sb])

Him G. Kwee, M.D.
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Cite this page: Kwee HG. Durvalumab. PathologyOutlines.com website. https://www.pathologyoutlines.com/topic/drugsgdurvalumab.html. Accessed January 22nd, 2021.
Definition / general
  • Human IgG1 kappa monoclonal antibody that blocks the interaction of PDL1 with PD1 and CD80
  • PDL1 blocks T cell function through interaction with PD1 and CD80
  • Blockade of PDL1 by durvalumab releases the inhibition of immune responses without inducing antibody dependent cell mediated cytotoxicity
  • Astra Zeneca: Imfinzi product insert [Accessed 14 December 2018]
Trade name
  • Imfinzi®
  • Locally advanced or metastatic urothelial carcinomas that have:
    • Progression during or after platinum containing chemotherapy or
    • Progression within 12 months of neoadjuvant or adjuvant treatment with platinum containing chemotherapy
  • Unresectable stage III non small cell lung cancer that has not progressed following concurrent platinum based chemotherapy and radiation therapy (Astra Zeneca: Imfinzi product insert [Accessed 14 December 2018])
Uses by pathologists
  • FDA has approved a companion test: Ventana PDL1 (SP263) immunohistochemistry assay using a rabbit monoclonal anti-PDL1 clone 263 to assess PDL1 protein in FFPE urothelial carcinoma tissue stained with OptiView DAB IHC detection kit on a Ventana BenchMark Ultra instrument
  • Scoring method:
    • Determine the percentage of tumor cells with any membranous staining above background or
    • Percentage of tumor associated immune cells with staining at any intensity above background (IC+) or
    • Percentage of tumor area occupied by tumor associated immune cells (ICP)
  • PDL1 status is high if any of these conditions are met:
    • At least 25% of tumor cells show membranous staining or
    • ICP is greater than 1% and IC+ is at least 25% or
    • ICP is at least 1% and IC+ is 100%
  • This test is a useful tool to help determine the likelihood of the urothelial carcinoma responding to durvalumab, but it is not required for the use of durvalumab
  • For nonsmall cell lung cancer the cutoff criteria is at least 25% of tumor cells with membranous staining (Arch Pathol Lab Med 2018;142:26)
  • A blueprint project to evaluate the comparability of the various PDL1 assays (including SP263) had been published (J Thorac Oncol 2017;12:208)
Board review style question #1
    Which of the following factors is not part of the assessment of PDL1 status of urothelial carcinoma using the Ventana PDL1 (SP263) antibody:

  1. Percentage of tumor area occupied by tumor associated immune cells
  2. Percentage of tumor cells with membranous staining
  3. Percentage of tumor cells with nuclear staining
  4. Percentage of tumor-associated immune cells with positive staining
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