PD-L1 Testing Update (AACR 2017)

The FDA has approved two PD-L1 immunohistochemistry (IHC) assays for use with anti-PD-L1 antibody drugs: Dako PD-L1 IHC 28-8 pharmDx assay (Dako 28-8) and Dako PD-L1 IHC 22C3 pharmDx assay (Dako 22C3), with data confirming specimen concordance in clinical settings. This information was presented at the American Association for Cancer Research (AACR) Annual Meeting held in Washington, D.C. from April 1–5, 2017, by Cory Batenchuk of Bristol-Myers Squibb.

When selecting anti-PD-L1 drug therapy, the FDA accepts two companion diagnostic options:

• Dako 28-8 (using the 28-8 antibody): Used for confirmation prior to Nivolumab treatment in melanoma and non-small cell lung cancer (NSCLC).
• Dako 22C3 (using the 22C3 antibody): Used for confirmation prior to Pembrolizumab treatment in NSCLC patients.

The presentation included substantial data demonstrating correlations between these assays. A total of 5,217 test results were obtained from PD-L1 IHC biospecimens from 4,528 patients with various cancer types. Of these, 556 specimens were selected for analysis, with lung cancer patients accounting for 158 cases (28%). The key takeaway of the study was that both Dako 28-8 and Dako 22C3 can be used for PD-L1 IHC analysis.

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Related Cancer Information

• Melanoma
• Lung cancer