2 december 2017: klik op de titel:

Currently, in the clinical setting outside of trials, PD-L1 testing is advised for those with advanced NSCLC who do not have tumors harboring epidermal growth factor receptor (EGFR) mutation or rearrangements in the ALK or ROS gene and who are being considered for pembrolizumab therapy.


  • Three of five appear to be interchangeable.
  • Thus, it might be possible to use only one assay when considering any of the three drugs for which the tests were developed.
  • In the clinical setting, PD-L1 testing is currently required for pembrolizumab treatment selection in NSCLC.

“For first-line therapy of NSCLC, the pembrolizumab 22C3 assay is FDA-approved with a tumor proportion score of 50% or more as the cutoff. Otherwise, it is still an ongoing research tool in clinical trials. For second-line therapy of NSCLC, pembrolizumab is FDA-approved with the companion diagnostic test using a lower cutoff (ie, > 1%), and other immunotherapy agents are approved with PD-L1 as a complementary diagnostic,” Dr. Hirsch said. A companion test is essential for use of the drug, whereas a complementary assay is used to optimize patient selection, he clarified (see Table 1 on page 28). ■

1. Tsao MS, Yatabe Y, Hirsch FR, et al: Blueprint 2: PD-L1 immunohistochemistry comparability in real-life clinical samples. 2017 IASLC World Conference on Lung Cancer. Abstract PL3.03. Presented October 18, 2017.

2. Hirsch FR, McElhinny A, Stanforth D, et al: PD-L1 immunohistochemistry assays for lung cancer: Results from phase 1 of the Blueprint PD-L1 IHC Assay Comparison Project. J Thorac Oncol 2:208-222, 2017.

3. Diggs LP, Hsueh EC: Utlility of PD-L1 immunohistochemistry assays for predicting PD-1/PD-L1 inhibitor response. Biomark Res 5:12, 2017.

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