Development of a clinical trial assay for PD-L1 immunohistochemistry (IHC) for use with pembrolizumab (pembro) clinical trials in melanoma.

Dolled‐Filhart, Marisa; Ebbinghaus, Scot; Roach, Charlotte; Ponto, Gary; Toland, Grant; Jansson, Malinka; Emancipator, Kenneth

doi:10.1200/jco.2016.34.15_suppl.9571

JCO

2016

DOI: 10.1200/jco.2016.34.15_suppl.9571

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Development of a clinical trial assay for PD-L1 immunohistochemistry (IHC) for use with pembrolizumab (pembro) clinical trials in melanoma.

Marisa Dolled‐Filhart

Scot Ebbinghaus

Charlotte Roach³

et al.

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“…PD-L1 expression is a continuous variable ranging from 0% to 100% based on the percentage of tumor cells in a tissue specimen that display partial or complete PD-L1 membrane staining of any intensity ( 7 , 8 ). In some assays, the percentage of tumor-infiltrating immune cells with PD-L1 staining is also measured ( 7 , 8 ). PD-L1 is often reported in a dichotomous fashion, where tumors are defined as either “PD-L1 high” or “PD-L1 low” based on a selected PD-L1 cutpoint.…”

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confidence: 99%

Response Rate and Survival at Key Timepoints With PD-1 Blockade vs Chemotherapy in PD-L1 Subgroups: Meta-Analysis of Metastatic NSCLC Trials

Man

Millican

Mulvey

et al. 2021

JNCI Cancer Spectrum

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Background PD-L1 expression (PD-L1) on tumor cells with or without immune cells is widely reported in clinical trials of PD-1 blockade in metastatic non-small cell lung cancer (NSCLC). Various cutpoints have been studied. Methods We performed a systematic search of MEDLINE, EMBASE and conference proceedings up to December 2019 for randomized and non-randomized clinical trials of anti-PD-1 or anti-PD-L1 monotherapy in metastatic NSCLC. We retrieved data on objective response rate (ORR), 1 year (1yr PFS) and 2 year progression-free survival (2yr PFS), and 2 year (2yr OS) and 3 year overall survival (3yr OS) in various PD-L1 subgroups. Results were pooled and analysed based on different cutpoints, with non-randomized comparisons made to pooled chemotherapy outcomes. Results 9,810 patients in twenty-seven studies were included. In treatment-naïve patients, benefits with PD-1 blockade over chemotherapy were seen in ORR in patients having PD-L1 ≥50%, in 2yr OS for PDL1 ≥1%, and in 1yr PFS, 2yr PFS and 3yr OS for unselected patients. First-line PD-1 blockade compared to chemotherapy demonstrated higher ORR, 2yr PFS and 3yr OS if PD-L1 ≥50%; lower ORR, higher 2yr PFS and similar 3yr OS if PD-L1 1-49%; and lower ORR, similar 1yr PFS and lower 2yr OS if PD-L1 <1%. In previously treated patients, PD-1 blockade demonstrated similar or superior outcomes to chemotherapy in all PD-L1 subgroups. Conclusions PD-L1 should guide the choice of PD-1 blockade versus chemotherapy in treatment-naïve patients. In previously treated patients, PD-1 blockade provides a favourable outcome profile to chemotherapy in all PD-L1 subgroups.

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Response Rate and Survival at Key Timepoints With PD-1 Blockade vs Chemotherapy in PD-L1 Subgroups: Meta-Analysis of Metastatic NSCLC Trials

Man

Millican

Mulvey

et al. 2021

JNCI Cancer Spectrum

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Development of a clinical trial assay for PD-L1 immunohistochemistry (IHC) for use with pembrolizumab (pembro) clinical trials in melanoma.

Cited by 1 publication

References 0 publications

Response Rate and Survival at Key Timepoints With PD-1 Blockade vs Chemotherapy in PD-L1 Subgroups: Meta-Analysis of Metastatic NSCLC Trials

Response Rate and Survival at Key Timepoints With PD-1 Blockade vs Chemotherapy in PD-L1 Subgroups: Meta-Analysis of Metastatic NSCLC Trials

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