一文读懂PD-L1 检测之SP263的前世今生（转载）

一文读懂PD-L1 检测之SP263的前世今生

肿瘤资讯 昨天

来源：肿瘤资讯

转自：良医汇-肿瘤医生APP

2020年5月8日，继美国FDA和欧盟CE IVD批准后，罗氏诊断VENTANA PD-L1 (SP263) 免疫组织化学 (IHC)伴随诊断正式获国家药品监督管理局(NMPA)批准上市[1]。本文小编试图从PD-L1 (SP263) 两篇关键R&D文献[6][10]和关键临床注册研究[4][5][9]一窥PD-L1 IHC检测的“前世今生”，或对未来在病理实验室PD-L1 IHC标准化、规范化开展有所提示。

参考文献

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[7] Hegde, Priti S., Vaios Karanikas, and Stefan Evers. The where, the when, and the how of immune monitoring for cancer immunotherapies in the era of checkpoint inhibition. (2016): 1865-1874.

[8] Hegde, Priti S., and Daniel S. Chen. Top 10 Challenges in Cancer Immunotherapy. Immunity 52.1 (2020): 17-35.

[9]https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?ID=394004

[10] Scorer, Paul, et al. Consistency of tumor and immune cell programmed cell death ligand-1 expression within and between tumor blocks using the VENTANA SP263 assay. Diagnostic pathology 13.1 (2018): 47.

[11] VENTANA PD-L1 (SP263) Assay (CE IVD) Package Insert.

[12] Lantuejoul, Sylvie, et al. PD-L1 Testing for Lung Cancer in 2019: Perspective From the IASLC Pathology Committee. Journal of Thoracic Oncology (2019).

[13] https://fda.report/PMA/P160046

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[16] Ye, D., et al. First report of efficacy and safety from a phase II trial of tislelizumab, an anti-PD-1 antibody, for the treatment of PD-L1+ locally advanced or metastatic urothelial carcinoma (UC) in Asian patients. Annals of Oncology 30 (2019): v367.

[17] Reck, Martin, et al. Pembrolizumab versus chemotherapy for PD-L1–positive non–small-cell lung cancer. New England Journal of Medicine 375.19 (2016): 1823-1833.

[18] Herbst, Roy S., et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. The Lancet 387.10027 (2016): 1540-1550.

[19] Borghaei, Hossein, et al. Nivolumab versus docetaxel in advanced nonsquamous non–small-cell lung cancer. New England Journal of Medicine 373.17 (2015): 1627-1639.

[20] Ratcliffe, Marianne J., et al. Agreement between programmed cell death ligand-1 diagnostic assays across multiple protein expression cutoffs in non–small cell lung cancer. Clinical Cancer Research 23.14 (2017): 3585-3591.

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[22] Antonia, Scott J., et al. Overall survival with durvalumab after chemoradiotherapy in stage III NSCLC. New England Journal of Medicine 379.24 (2018): 2342-2350.

[23] Hirsch, Fred R., et al. PD-L1 immunohistochemistry assays for lung cancer: results from phase 1 of the blueprint PD-L1 IHC assay comparison project. Journal of Thoracic Oncology 12.2 (2017): 208-222.

[24] Tsao, Ming Sound, et al. PD-L1 immunohistochemistry comparability study in real-life clinical samples: results of blueprint phase 2 project. Journal of Thoracic Oncology 13.9 (2018): 1302-1311.

[25] 袁培, 郭嫦媛, 李媛, 等.  晚期肺腺癌活检标本PD－L1免疫组织化学多平台检测一致性研究 [J] . 中华病理学杂志,2018,47( 11 ): 840-844. DOI: 10.3760/cma.j.issn.0529-5807.2018.11.005

[26]https://www.nordiqc.org/downloads/assessments/121_106

[27]https://www.nordiqc.org/downloads/assessments/125_110

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