Non-small cell lung cancer
PD-L1 IHC 22C3 pharmDx for Autostainer Link 48
IVD
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 gastric or GEJ adenocarcinoma, ESCC, cervical cancer, urothelial carcinoma, HNSCC, and TNBC 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.
PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC, gastric or GEJ adenocarcinoma, ESCC, cervical cancer, urothelial carcinoma, HNSCC, and TNBC patients for treatment with KEYTRUDA® (pembrolizumab). Please refer to the full intended use for indications and PD-L1 expression levels.
PD-L1 IHC 22C3 pharmDx kit
The kit includes reagents required for the immunohistochemical staining (except EnVision FLEX Wash Buffer and Hematoxylin (Link)), control slides representing different expression levels of PD-L1 protein, 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).
For countries outside of Mexico, see the local KEYTRUDA product label for approved indications and expression cutoff values to guide therapy.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
For In Vitro Diagnostic Use.
Product Details
Featured References
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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.
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6. Chung HC, Schellens JHM, Delord J-P, et al. Pembrolizumab treatment of advanced cervical cancer: updated results from the phase 2 KEYNOTE-158 study. J Clin Oncol. 2018;36(Suppl 15):5522.
7. Burtness B, Harrington KJ, Greil R, Soulières D, Tahara M et al. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomized, open-label, phase 3 study. Lancet 2019;394(10212):1915-28.
8. 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.
9. 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 1000-1000.
10. Sezer A, Kilickap S, Gümüs M, et al. Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial. Lancet 2021;397(10274): 592-604
