Non-squamous NSCLC
PD-L1 IHC 28-8 pharmDx for Autostainer Link 48
IVD
PD-L1 protein expression in NSCLC, SCCHN, and UC is determined by the percentage of evaluable tumor cells exhibiting partial or complete membrane staining at any intensity.
PD-L1 protein expression in esophageal squamous cell carcinoma (ESCC), gastric adenocarcinoma, GEJ adenocarcinoma, and esophageal 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.
Companion Diagnostic Indications
NSCLC
PD-L1 IHC 28-8 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with OPDIVO® (nivolumab) in combination with YERVOY® (ipilimumab). PD-L1 expression clinical cutoff ≥ 1% tumor cell expression.
ESCC
PD-L1 IHC 28-8 pharmDx is indicated as an aid in identifying ESCC patients for treatment with OPDIVO® (nivolumab) or OPDIVO QVANTIG® (nivolumab and hyaluranidase-nvhy). PD-L1 expression clinical cutoff CPS ≥ 1%.
Gastric, GEJ, or esophageal adenocarcinoma
PD-L1 IHC 28-8 pharmDx is indicated as an aid in identifying gastric, GEJ, or esophageal adenocarcinoma patients for treatment with OPDIVO® (nivolumab) or OPDIVO QVANTIG® (nivolumab and hyaluranidase-nvhy). PD-L1 expression clinical cutoff CPS ≥ 1%.
When used in accordance with approved therapeutic labeling:
Non-squamous NSCLC
PD-L1 expression (≥ 1% or ≥ 5% or ≥ 10% tumor cell expression), as detected by PD-L1 IHC 28-8 pharmDx in non-squamous NSCLC may be associated with enhanced survival from OPDIVO® (nivolumab).
SCCHN
PD-L1 expression (≥1% tumor cell expression), as detected by PD-L1 IHC 28-8 pharmDx in SCCHN may be associated with enhanced survival from OPDIVO® (nivolumab).
UC
PD-L1 expression (≥1% tumor cell expression) as detected by PD-L1 IHC 28-8 pharmDx in UC may be associated with enhanced response rate and enhanced disease-free survival from OPDIVO® (nivolumab).
PD-L1 IHC 28-8 pharmDx is subject to an exclusive trademark license to Agilent Technologies, Inc. OPDIVO®, OPDIVO QVANTIG®, and YERVOY® are registered trademarks owned by Bristol-Myers Squibb.
For details on staining interpretation, refer to the Instructions for Use and indication-specific PD-L1 IHC 28-8 pharmDx, Code SK005 Interpretation Manuals
For In Vitro Diagnostic Use.
Product Details
Features
- The kit includes reagents required for the immunohistochemical staining (except wash buffer), control slides containing two cell lines representing positive and negative expression 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 rabbit antibody to PD-L1 and 50 slides incubated with the corresponding Negative Control Reagent, 100 slides in total).
Featured References
- Product Description References
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1. Phillips, T.; Simmons, P.; Inzunza, H. D.; Cogswell, J.; Novotny, J., Jr.; Taylor, C.; Zhang, X.; Thomas, R.; Kelly, K.; Marsh, S.; et al. Development of an Automated PD-L1 Immunohistochemistry (IHC) Assay for Non-Small Cell Lung Cancer. Appl. Immunohistochem. Mol. Morphol. 2015, 23 (8), 541–549. DOI: 10.1097/PAI.0000000000000256
2. Borghaei, H.; Paz-Ares, L.; Horn, L.; Spigel, D. R.; Steins, M.; Ready, N. E.; Chow, L. Q. M.; Vokes, E. E.; Felip, E.; Holgado, E.; et al. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N. Engl. J. Med. 2015, 373, 1627–1639. DOI: 10.1056/NEJMoa1507643.
3. Ferris, R. L.; Blumenschein, G., Jr.; Fayette, J.; Guigay, J.; Colevas, A. D.; Licitra, L.; Harrington, K.; Kasper, S.; Vokes, E. E.; Even, C.; et al. Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck. N. Engl. J. Med. 2016, 375, 1856–1867. DOI: 10.1056/NEJMoa1602252.
4. Sharma, P.; Retz, M.; Siefker-Radtke, A.; Baron, A.; Necchi, A.; Bedke, J.; Plimack, E. R.; Vaena, D.; Grimm, M.-O.; Bracarda, S.; et al. Nivolumab in Metastatic Urothelial Carcinoma after Platinum Therapy (CheckMate 275): A Multicentre, Single-Arm, Phase 2 Trial. Lancet Oncol. 2017, 18 (3), 312–322. DOI: 10.1016/S1470-2045(17)30065-7.
5. Bajorin, D. F.; Witjes, J. A.; Gschwend, J. E.; Schenker, M.; Valderrama, B. P.; Tomita, Y.; Bamias, A.; Lebret, T.; Shariat, S. F.; Park, S. H.; et al. Adjuvant Nivolumab versus Placebo in Muscle-Invasive Urothelial Carcinoma. N. Engl. J. Med. 2021, 384 (22), 2102–2114. DOI: 10.1056/NEJMoa2034442.
6. Hellmann, M. D.; Paz-Ares, L.; Bernabe Caro, R.; Zurawski, B.; Kim, S.-W.; Costa, E. C.; Park, K.; Alexandru, A.; Lupinacci, L.; de la Mora Jimenez, E.; et al. Nivolumab plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer. N. Engl. J. Med. 2019, 381 (21), 2020–2031. DOI: 10.1056/NEJMoa1910231.
7. Doki, Y.; Ajani, J. A.; Kato, K.; Xu, J.; Wyrwicz, L.; Motoyama, S.; Satoh, T.; Chao, Y.; Li, J.; Shah, M. A.; et al. Nivolumab Combination Therapy in Advanced Esophageal Squamous-Cell Carcinoma. N. Engl. J. Med. 2022, 386 (5), 449–462. DOI: 10.1056/NEJMoa2111380.
8. Janjigian, Y. Y.; Shitara, K.; Moehler, M.; Garrido, M.; Salman, P.; Shen, L.; Wyrwicz, L.; Yamaguchi, K.; Skoczylas, T.; Campos Bragagnoli, A.; et al. First-line Nivolumab plus Chemotherapy versus Chemotherapy Alone for Advanced Gastric, Gastro-oesophageal Junction, and Oesophageal Adenocarcinoma (CheckMate 649): A Randomised, Open-label, Phase 3 Trial. Lancet 2021, 398 (10294), 27–40. DOI: 10.1016/S0140-6736(21)00797-2.
