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Patients are denied a drug when a test says they will not benefit, but that restriction is usually inferred from enrichment trials rather than tested. For high-stakes markers with weak evidence in the negative group, such as PD-L1 and HER2 0, randomised trials in biomarker-negative patients should test the assumption itself.
Label restrictions based on biomarkers are often inferred from enrichment trials or subgroup analyses rather than from tests of the biomarker-negative population. For high-stakes markers with weak evidence in the negative group (PD-L1 in several tumours, HER2-ultralow and HER2 0, HRD-negative for PARP inhibitors), academic randomised trials in the biomarker-negative population with pragmatic endpoints would either open access to a denied group or firmly justify the restriction.
Patients with hormone-receptor-positive metastatic breast cancer that has stopped responding to endocrine therapy can be offered trastuzumab deruxtecan as their first chemotherapy-type treatment if the tumour shows any HER2 staining, rather than waiting until after conventional chemotherapy. Whether to use it before or after chemotherapy is now a choice, since overall survival was not shown to differ and the drug carries a risk of lung inflammation.
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Shares Test the drug in biomarker-negative patients too, so the biomarker can be validated, Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue, Biomarkers are not validated or standardised, PD-L1.
Shares DESTINY-Breast06, DESTINY-Breast06: trastuzumab deruxtecan before any chemotherapy in hormone-receptor-positive, HER2-low or ultralow breast cancer, HER2-low and HER2-ultralow, Trastuzumab deruxtecan.
Shares DESTINY-Breast06, HER2-low and HER2-ultralow, Trastuzumab deruxtecan.
Shares Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue, No one can predict who responds to immunotherapy, Biomarkers are not validated or standardised.
Shares Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue, No one can predict who responds to immunotherapy, Biomarkers are not validated or standardised, PD-L1.
Shares Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue, Biomarkers are not validated or standardised.
Shares Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue, Biomarkers are not validated or standardised.
Shares DESTINY-Breast06, DESTINY-Breast06: trastuzumab deruxtecan before any chemotherapy in hormone-receptor-positive, HER2-low or ultralow breast cancer, HER2-low and HER2-ultralow, Trastuzumab deruxtecan.