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20 insertions (A775_G776insYVMA)","position":776,"kind":"activating","frequency":"About 2 to 4% of non-squamous NSCLC carries a HER2 mutation, mostly exon 20 insertions","drugs":["trastuzumab-deruxtecan","zongertinib","sevabertinib","pyrotinib"]},{"label":"S310F / S310Y","position":310,"kind":"activating","drugs":["neratinib","zongertinib","trastuzumab-deruxtecan"]},{"label":"L755S / V777L / D769H","position":755,"kind":"activating","drugs":["neratinib","tucatinib","trastuzumab-deruxtecan"]}],"openQuestions":[{"id":"her2-low-ultralow-scoring","question":"How should pathologists reliably separate HER2-low and HER2-ultralow from HER2-zero when the assays were designed to find HER2-high?","stage":"implementation","actor":"regulator","source":{"label":"DESTINY-Breast04, NEJM 2022","url":"https://doi.org/10.1056/NEJMoa2203690"}},{"id":"her2-adc-sequencing","question":"After trastuzumab deruxtecan, does a second HER2-directed ADC with a different payload work, or is payload resistance shared?","stage":"clinical","actor":"clinic","source":{"label":"DESTINY-Breast03, NEJM 2022","url":"https://doi.org/10.1056/NEJMoa2115022"}}],"assays":[{"id":"her2-herceptest","name":"HercepTest","cutoff":"IHC 3+ (or 2+ confirmed by ISH) for trastuzumab; IHC 1+ or 2+/ISH-negative (HER2-low) for trastuzumab deruxtecan; IHC 0 with faint membrane staining (HER2-ultralow) for trastuzumab deruxtecan in HR-positive breast cancer"},{"id":"her2-pathway-4b5","name":"PATHWAY anti-HER2/neu (4B5)","cutoff":"IHC 3+ (HER2-positive); IHC 1+ or 2+/ISH-negative (HER2-low) for trastuzumab deruxtecan; IHC 3+ solid tumours for tumour-agnostic trastuzumab deruxtecan"},{"id":"her2-ish","name":"HER2 IQFISH pharmDx and INFORM HER2 Dual ISH","cutoff":"HER2/CEP17 ratio at least 2.0, or ratio below 2.0 with average HER2 copy number at least 6.0 (ASCO/CAP 2018)"},{"id":"foundationone-cdx-panel","name":"FoundationOne CDx","cutoff":"Per companion claim: EGFR, ALK, BRAF V600, ERBB2 amplification, KRAS wild-type, BRCA1/2 and HRR genes, PIK3CA, MET exon 14, RET, FGFR2 fusions, IDH1, NTRK fusions; MSI-high; TMB at least 10 mutations per megabase"},{"id":"guardant360-cdx","name":"Guardant360 CDx","cutoff":"Per companion claim: EGFR (osimertinib), EGFR exon 20 insertions (amivantamab), KRAS G12C (sotorasib), ESR1 mutations (elacestrant), ERBB2 mutations (zongertinib); negative plasma reflexes to tissue"}],"resistance":[{"class":"top1-adc","mechanism":"Payload resistance: TOP1 mutation or loss","category":"payload"},{"class":"top1-adc","mechanism":"SLFN11 loss","category":"payload"},{"class":"top1-adc","mechanism":"Efflux pump upregulation (ABCG2, ABCB1)","category":"payload"},{"class":"top1-adc","mechanism":"Antigen loss or downregulation","category":"antigen"},{"class":"top1-adc","mechanism":"Impaired internalisation / lysosomal processing","category":"pharmacology"},{"class":"cdk46-endocrine","mechanism":"RB1 loss","category":"bypass"}],"licence":"CC BY-NC 4.0, attribution to OnCo (https://onco.cc); commercial use needs a licence"}