Loading
Three commercial PD-L1 stains give different answers on the same breast tumour: the SP142 assay used with atezolizumab called fewer than half of tumours positive while the 22C3 and SP263 assays called about three quarters. Because the pembrolizumab licence rests on 22C3 combined positive score 10, which test a laboratory runs, and how it scores it, decides who is offered immunotherapy.
In a central re-analysis of 614 IMpassion130 tumours (68.1 percent of the trial population), PD-L1 on immune cells at 1 percent or more was present in 46.4 percent by VENTANA SP142, 74.9 percent by SP263 and 73.1 percent by Dako 22C3, and 80.9 percent had a 22C3 combined positive score of 1 or more; analytical concordance of SP263 and 22C3 with SP142 was 69.2 and 68.7 percent; almost all SP142-positive cases were positive on the other assays, but 29.6 percent of SP263-positive and 29.0 percent of 22C3-positive cases were SP142-negative; the atezolizumab benefit in SP263- and 22C3-positive patients (progression-free survival hazard ratios 0.64 to 0.68, overall survival 0.75 to 0.79) was driven by the double-positive cases, and single-positive cases showed overall survival hazard ratios of 0.87 to 0.95 (Rugo 2021, the paper record on this site). The assays also answer different questions: SP142 in IMpassion130 scored PD-L1 on tumour-infiltrating immune cells as a percentage of tumour area at a 1 percent cut-off (Schmid 2018), whereas KEYNOTE-355 used the 22C3 combined positive score, which counts staining tumour cells, lymphocytes and macrophages against all viable tumour cells, with the benefit confined to CPS 10 or more (Cortes 2020; Cortes 2022). Only the 22C3 CPS 10 threshold has an approved and NICE-recommended drug attached in triple-negative disease (TA801); the parent page records that the atezolizumab US indication was withdrawn and lists assay harmonisation among its open problems. The biomarker readouts pd-l1-cps and pd-l1-ic-score carry the label wording for each score.
In plain words · PD-L1 is the tumour's side of the PD-1 brake, and also the biomarker that decides who gets immunotherapy.
Showing the target this term concerns: PD-L1.
Shares PD-L1 combined positive score 10 in triple-negative breast cancer, Metastatic triple-negative breast cancer, Triple-negative breast cancer (TNBC) and the tags breast, tnbc.
Shares PD-L1 combined positive score 10 in triple-negative breast cancer, KEYNOTE-355, Combined positive score (CPS), PD-L1 and the tags breast, tnbc.
Shares Metastatic triple-negative breast cancer, Triple-negative breast cancer (TNBC) and the tags breast, tnbc.
Shares Triple-negative breast cancer (TNBC) and the tags breast, tnbc.
Shares Triple-negative breast cancer (TNBC) and the tags breast, tnbc.
Shares Triple-negative breast cancer (TNBC) and the tags breast, tnbc.
Shares Triple-negative breast cancer (TNBC) and the tags breast, tnbc.
Shares Triple-negative breast cancer (TNBC) and the tags breast, tnbc.