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 ESCC, cervical cancer, HNSCC, TNBC, gastric or GEJ adenocarcinoma, and EOC 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, ESCC, cervical cancer, HNSCC, TNBC, gastric or GEJ adenocarcinoma, and EOC patients for treatment with KEYTRUDA® (pembrolizumab). PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with LIBTAYO® (cemiplimab-rwlc). Refer to the full Intended Use in the current version of the PD-L1 IHC 22C3 pharmDx, Code SK006 Instructions for Use for approved indications and PD-L1 expression cutoff values guiding therapy.
For details on staining interpretation, refer to section 13 of the Instructions for Use and indication-specific PD-L1 IHC 22C3 pharmDx, Code SK006 Interpretation Manuals.
PD-L1 IHC 22C3 pharmDx, Code SK006
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).
For countries outside of the United States, see the local KEYTRUDA® (pembrolizumab) product label for approved indications and PD-L1 expression cutoff values to guide therapy.
KEYTRUDA® (pembrolizumab) is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA
LIBTAYO® is a registered trademark of Regeneron Pharmaceuticals, Inc.
For In Vitro Diagnostic Use.
Product Details
Featured References
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2. Keytruda® Package Insert. Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, Rahway, NJ, USA.
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8. Schellens, J. H. M.; Marabelle, A.; Zeigenfuss, S.; et al. Pembrolizumab for Previously Treated Advanced Cervical Squamous Cell Cancer: Preliminary Results from the Phase 2 KEYNOTE-158 Study. J. Clin. Oncol. 2017, 35 (15), 5514–5514.
9. Burtness B, Harrington KJ, Greil R, 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 randomised, open-label, phase 3 study. Lancet 2019, 394 (10212),1915-1928.
10. Sezer, A.; Kilickap, S.; Gümüş, 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.
