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In metastatic triple-negative breast cancer the immunotherapy pembrolizumab is only given when a PD-L1 stain of the tumour scores 10 or more on the combined positive score, because that is the group in which the trial showed people lived longer. For early disease before surgery no PD-L1 test is needed: pembrolizumab helped regardless.
The combined positive score is the number of PD-L1-staining tumour cells, lymphocytes and macrophages divided by the total number of viable tumour cells, multiplied by 100 (Cortes 2022). KEYNOTE-355 randomised 847 patients with untreated locally recurrent inoperable or metastatic triple-negative breast cancer 2:1 to pembrolizumab or placebo with the investigator's chemotherapy (nab-paclitaxel, paclitaxel or gemcitabine-carboplatin), with PD-L1 tested centrally by the 22C3 assay. Progression-free survival at the interim analysis was 9.7 against 5.6 months in the CPS 10 or more group (hazard ratio 0.65, primary objective met), 7.6 against 5.6 months in CPS 1 or more (0.74, not significant) and 7.5 against 5.6 months overall (0.82, not tested), the effect increasing with PD-L1 enrichment (Cortes 2020). At the final analysis (median follow-up 44.1 months) overall survival in the CPS 10 group was 23.0 against 16.1 months (hazard ratio 0.73, significant), 17.6 against 16.0 months in CPS 1 or more (0.86, not significant) and 17.2 against 15.5 months in all patients (0.89, not tested); grade 3 to 5 treatment-related events occurred in 68.1 against 66.9 percent (Cortes 2022). NICE recommends pembrolizumab with paclitaxel or nab-paclitaxel for untreated triple-negative locally recurrent unresectable or metastatic breast cancer in the population the appraisal covers (TA801, June 2022). A different assay and score defined the earlier atezolizumab result: IMpassion130 used the SP142 immune-cell score with positivity at 1 percent or more of the tumour area; median progression-free survival was 7.5 against 5.0 months and overall survival 25.0 against 15.5 months in the PD-L1-positive subgroup, without a significant overall survival gain in the whole population (Schmid 2018), and the parent page's history records that approval was later withdrawn. Early disease needs no PD-L1 test: in KEYNOTE-522 pembrolizumab with chemotherapy raised pathological complete response from 51.2 to 64.8 percent in stage II and III disease unselected for PD-L1 (Schmid 2020) and five-year overall survival from 81.7 to 86.6 percent (Schmid 2024); NICE TA851 (December 2022) recommends it for triple-negative early or locally advanced breast cancer at high risk of recurrence. The biomarker readout pd-l1-cps carries the label wording for every CPS threshold across cancers.
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 Exceptional responder, Early triple-negative breast cancer, Triple-negative breast cancer (TNBC) and the tags breast, tnbc.
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Shares Metastatic triple-negative breast cancer, Triple-negative breast cancer (TNBC) and the tags breast, tnbc.
Shares Early triple-negative breast cancer, Triple-negative breast cancer (TNBC) and the tags breast, tnbc.
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Shares Triple-negative breast cancer (TNBC) and the tags breast, tnbc.