NCCN Clinical Practice Guidelines In Oncology (NCCN Guidelines®) recommend routine PD-L1 testing for metastatic NSCLC patients at diagnosis
Pembrolizumab (KEYTRUDA) is a category 1* recommendation for metastatic NSCLC patients who express ≥ 50% PD-L1—the highest National Comprehensive Cancer Network® (NCCN®) category of evidence and consensus
In first-line treatment: Recommended for patients with PD-L1 expression levels ≥ 50% when test results for sensitizing EGFR mutations, ALK rearrangements, ROS1 rearrangements, and BRAF V600E mutations are negative or unknown
In subsequent therapy: Recommended as a treatment option for patients with PD-L1 expression levels ≥ 1%, if pembrolizumab not previously given
* Category 1: Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.
† Consider rebiopsy if appropriate. If repeat biopsy is not feasible, plasma testing should be considered.
PD-L1 IHC 22C3 pharmDx NSCLC Interpretation ManualRefer to the NSCLC Interpretation Manual to review validated scoring guidelines that can aid in the identification of NSCLC patients for treatment with KEYTRUDA
Table 1: PD-L1 prevalencea in patients with NSCLCb screened for KEYNOTE-024c
a. Merck & Co., data on file; b. Patients screened for enrollment in KEYNOTE-024 NSCLC; c. International phase 3 study comparing pembrolizumab with investigator's choice platinum-containing chemotherapy (including pemetrexed+carboplatin, pemetrexed+cisplatin, gemcitabine+cisplatin, gemcitabine+carboplatin, or paclitaxel+carboplatin) in patients with non-small cell lung carcinoma who were previously untreated for advanced metastatic disease. ClinicalTrials.gov number NCT02142738.
Table 2: PD-L1 prevalenced in patients with NSCLCe screened for KEYNOTE-010f
d. Merck & Co., data on file; e. Patients screened for enrollment in KEYNOTE-010 NSCLC; f. International phase 2/3 study comparing pembrolizumab with docetaxel in patients with non-small cell lung carcinoma who have experienced disease progression after platinum-containing system therapy. ClinicalTrials.gov number NCT01905657.
For in vitro diagnostic use.
PD-L1 IHC 22C3 pharmDx is a qualitative immunohistochemical assay using Monoclonal Mouse Anti-PD-L1, Clone 22C3 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) and urothelial carcinoma tissues using EnVision FLEX visualization system on Autostainer Link 48.
Non-Small Cell Lung Cancer (NSCLC) PD-L1 protein expression in NSCLC is determined by using Tumor Proportion Score (TPS), which is the percentage of viable tumor cells showing partial or complete membrane staining at any intensity. The specimen should be considered to have PD-L1 expression if TPS ≥ 1% and high PD-L1 expression if TPS ≥ 50%.
PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with KEYTRUDA® (pembrolizumab). See the KEYTRUDA® product label for expression cutoff values guiding therapy in specific clinical circumstances.
Urothelial Carcinoma PD-L1 protein expression in urothelial carcinoma is determined by using Combined Positive Score (CPS), which is the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100. The specimen should be considered to have PD-L1 expression if CPS ≥ 10.
PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying urothelial carcinoma patients for treatment with KEYTRUDA® (pembrolizumab). See the KEYTRUDA® product label for specific clinical circumstances guiding PD-L1 testing.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.