Non-small cell lung cancer
PD-L1 IHC 22C3 pharmDx for Autostainer Link 48
IVD
Intended Use
For in vitro diagnostic use.
To measure the PD-L1 expression level in cancer tissue or cells (Indicated as an aid for proper administration of pembrolizumab [recombinant] in non-small cell lung cancer patients, head and neck cancer patients, esophageal cancer patients, breast cancer patients, cervical cancer patients, and gastric cancer patients.)
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), head and neck cancer (HNC), esophageal squamous cell carcinoma (ESCC), triple-negative breast cancer (TNBC), cervical cancer, and gastric cancer tissues using EnVision FLEX visualization system on Autostainer Link 48.
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.
PD-L1 protein expression in HNC, ESCC, TNBC, cervical cancer, and gastric cancer 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.
See the KEYTRUDA product label for specific clinical circumstances guiding PD-L1 testing.
For details on staining interpretation, refer to the Scoring Interpretation and Precautions for Interpretation’ section of the Instructions for Use and indication-specific PD-L1 IHC 22C3 pharmDx Interpretation Manuals.
PD-L1 IHC 22C3 pharmDx
The kit includes reagents required for the immunohistochemical staining (except EnVision FLEX Wash Buffer and Hematoxylin (Link)), control slides representing positive and negative PD-L1 protein expression, and detailed instructions. The kit has been tailored especially for use on Autostainer Link 48 instruments. The materials provided are sufficient for 50 tests (50 slides incubated with monoclonal mouse antibody to PD-L1 and 50 slides incubated with the corresponding negative control reagent, 100 slides in total).
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Product Details
Applications
Featured References
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1. Dolled-Filhart M, Roach C, Toland G, Stanforth D, Jansson M, Lubiniecki GM, et al. Development of a companion diagnostic for pembrolizumab in non-small cell lung cancer using immunohistochemistry for programmed death ligand-1. Arch Pathol Lab Med 2016;40(11):1243-9.
2. Roach C, Zhang N, Corigliano E, Jansson M, Toland G, Ponto G, et al. Development of a companion diagnostic PD-L1 immunohistochemistry assay for pembrolizumab therapy in non-small-cell lung cancer. Appl Immunohistochem Mol Morphol 2016;24:392-7.
3. Garon EB, Rizvi NA, Hui R, et al. Pembrolizumab for the treatment of non-small-cell lung cancer. New Eng J Med 2015;372:2018-28.
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, et al. Pembrolizumab versus chemotherapy for PD-L1–positive non–small-cell lung cancer. N Engl J Med 2016;375:1823-33.
6. Burtness B, Harrington KJ, Greil R, et al. KEYNOTE-048: Phase 3 study of first-line pembrolizumab (P) for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). ESMO 2018 Congress 2018. 22 October 2018.
7. Kojima T, Muro K, Francois E, Hsu C-H, Moriwaki T, Kim S-B, et al. Pembrolizumab vs chemotherapy as second-line therapy for advanced esophageal cancer: Phase 3 KEYNOTE-181 study. J Clin Oncol 2019;37(Supp 4):abstr 2.
8. Cortes J, Cescon DW, Rugo HS, et al. KEYNOTE-355: Randomized, double-blind, phase III study of pembrolizumab + chemotherapy versus placebo + chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer. J Clin Oncol 2020;38(Supp 15):abstr 1000.
9. Colombo N, Dubot C, Lorusso D, et al. Pembrolizumab for persistent, recurrent, or metastatic cervical cancer. N Engl J Med. 2021;385 (20):1856-1867.
10. Muro K, Chung HC, Shankaran V, Geva R, Catenacci D, Gupta S, Eder JP, Golan T, Le DT, Burtness B, McRee AJ, Lin CC, Pathiraja K, Lunceford J, Emancipator K, Juco J, Koshiji M, Bang YJ. Pembrolizumab for patients with PD-L1-positive advanced gastric cancer (KEYNOTE-012): a multicentre, open-label, phase 1b trial. Lancet Oncol 2016;17(6):717-726.
11. Fuchs CS, Doi T, Jang RW, Muro K, Satoh T, Machado M, et al. Safety and efficacy of pembrolizumab monotherapy in patients with previously treated advanced gastric and gastroesophageal junction cancer: Phase 2 clinical KEYNOTE-059 trial. JAMA Oncol 2018;4(5):e180013.
