Incorporate PD-L1 testing early

• To help ensure pathologists identify PD-L1 expression early for informed patient management
• To ensure that adequate patient sample material is available
• To ensure test results can be available regardless of the patient’s treatment center

The specimen should be considered PD-L1 positive if the tumor proportion score (TPS) ≥ 50% of the viable tumor cells exhibit membrane staining at any intensity (i.e. ≥ 1+).

• Prevalence of PD-L1 expression is variable in published literature, mostly due to unvalidated and varying tests and different patient populations
• The PD-L1 IHC 22C3 pharmDx was used in the KEYTRUDA (pembrolizumab) NSCLC study. ¹)

The specimen should be considered PD-L1 positive if the tumor proportion score (TPS) ≥ 50% of the viable tumor cells exhibit membrane staining at any intensity (i.e. ≥ 1+).

PD-L1 IHC 22C3 pharmDx expression is based on assessment of TPS.

a. Merck & Co, data on file
b. Patients screened for enrollment in KEYNOTE-001 NSCLC expansion cohorts C, F1, F2, F3
c. International phase 1 study evaluating pembrolizumab in patients with progressive locally advanced or metastatic carcinoma, melanoma, or non-small cell lung carcinoma. ClinicalTrials.gov number NCT01295827

(1) Garon EB, Rizvi NA, Hui R, Leighl N, Balmanoukian AS, Eder JP, et al. Pembrolizumab for the treatment of non-small-cell lung cancer. New Eng J Med 2015;372:2018-28.