Assay Purpose:
Diagnostic : Non-small cell lung carcinoma
Drug: Pembrolizumab (Merck)
Diagnostic test: PDL1 Dako 22C3 pharmDX

Result: Positive TPS >= 50%

Interpretation: Tumour Percentage Score (TPS) - Negative (< 1%), Low expression (1-49%), Positive (>= 50%)

Batch controls: Adequate; On slide controls: Adequate; Immune cell staining: Present; Disclaimer: Pembrolizumab is indicated for patients with advanced non-small cell lung carcinoma (stage IIIb and stage IV) whose tumors are PD-L1 positive with a total percentage score (TPS) >= 50% and with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK mutations should have disease progression on authorized therapy for these mutations (EGFR and ALK) prior receiving Pembrolizumab. PD-L1 22C3 pharm Dx was validated with tissue fixed in 10% neutral buffered formalin (NBF) for 12 to 72 hours. The method is not fully validated for shorter or longer fixation in NBF, other fixatives, extended ischemic time, treatment of tissue with microwaves or decalcification. This assay is not interchangeable with other PD-L1 assays and cannot be used for other type of cancers. Batch control includes 2 pelleted, formalin fixed paraffin embedded cell lines: NCI-H226 with moderate PD-L1 protein expression and MCF-7 with negative PD-L1 protein expression. On slide controls include one piece of tonsil (with expected PD-L1 staining positive in immune cells and keratinocytes) and one piece of liver (with expected PD-L1 staining negative in hepatocytes). https://www.nejm.org/doi/full/10.1056/nejmoa1501824