To aid in the identification of NSCLC patients for treatment with KEYTRUDA® (pembrolizumab).
PD-L1 22C3 IHC pharmDx is the only companion diagnostic approved by the FDA as an aid in identifying NSCLC patients for treatment with KEYTRUDA.Learn more about the key benefits
Incorporate into your diagnostic lung panel to provide clinically relevant results linked to patient outcomes.Read about early testing
The 2017 Educational Program lectures with prominent pathologists can be attended live or on-demand. The series has been developed in close cooperation with moderator Prof. Dr. Rector Magnificus Han J. M. van Krieken, Radboud University, Nijmegen, The Netherlands.Learn more and access the program
Validated scoring guidelines help identify patients more likely to respond to KEYTRUDA treatment.Scoring guidelines
Get the training that may help you accurately evaluate and score PD-L1 expression in patients with NSCLC for KEYTRUDA by participating in the PD-L1 IHC 22C3 pharmDx Pathology Training Program.Learn more and access the program >
Use the 22C3 Staining Atlas to increase your familiarity and confidence in scoring PD-L1 stains.Learn more and access the staining atlas
The first and only FDA-approved test to assess patients with NSCLC for KEYTRUDA.
Product: PD-L1 IHC 22C3 pharmDx
Platform: Autostainer Link 48
1. PD-L1 IHC 22C3 pharmDx - Package Insert
2. Keytruda [package insert]. Kenilworth, NJ: Merck & Co., Inc.; 2016.
3. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. See the KEYTRUDA product label for expression cutoff values guiding therapy in specific clinical circumstances.
4. Herbst RS, Baas P, Kim DW, Felip E, Pérez-Gracia JL, Han JY et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. Lancet 2016;387(10027):1540-50.
5. Reck M, Rodríguez-Abreu D, Robinson AG, Hui R, Csőszi T, Fülöp A et al. Pembrolizumab versus chemotherapy for PD-L1-positive non-small-cell lung cancer. NEJM 2016. DOI: 10.1056/NEJMoa1606774.
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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 gastric or gastroesophageal junction (GEJ) adenocarcinoma 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.
Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
PD-L1 protein expression in gastric or GEJ adenocarcinoma 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 is ≥ 1.
PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying gastric or GEJ adenocarcinoma patients for treatment with KEYTRUDA®.