PD-L1 IHC result generated using the Dako 22C3 pharmDx clone — the FDA-approved companion...

Детермінований перегляд YAML-сутності з джерельної бази. Клінічний авторитет лишається за вказаними source ID та статусом клінічного sign-off.

ID	`RF-PAN-PDL1-CLONE-22C3-PEMBRO-ELIGIBLE`
Тип	Тривожна ознака
Статус	переглянуто 2026-04-29 \| очікує клінічного підпису
Хвороби	Не вказано
Джерела	`SRC-CIVIC` `SRC-KEYNOTE-024-RECK-2016` `SRC-NCCN-BREAST-2025` `SRC-NCCN-NSCLC-2025`

Походження тривожної ознаки

Визначення	PD-L1 IHC result generated using the Dako 22C3 pharmDx clone — the FDA-approved companion-diagnostic clone for pembrolizumab indications across NSCLC (TPS), gastric / GEJ adenocarcinoma (CPS), esophageal squamous (CPS), urothelial (CPS), TNBC (CPS), cervical (CPS), and H&N squamous (CPS). Clone-platform identity matters because the Blueprint PD-L1 Comparison phase 1 + 2 studies (Hirsch JTO 2017; Tsao JTO 2018) showed 22C3 / 28-8 / SP263 as analytically near- equivalent for tumor-cell staining (NSCLC TPS), but SP142 (Ventana, atezolizumab CDx) markedly under-stains tumor cells and is NOT interchangeable. CPS (combined positive score; tumor + lymphocyte + macrophage staining) is operationally clone-22C3-anchored across pembrolizumab indications — substituting SP263 / 28-8 / SP142 for CPS-driven indication selection is off-label. Action: confirm 22C3 on the report; if a non-22C3 clone is t...
Клінічний напрям	investigate
Категорія	high-risk-biology

Логіка спрацьовування

{
  "all_of": [
    {
      "any_of": [
        {
          "finding": "pdl1_ihc_clone",
          "value": "22C3"
        },
        {
          "finding": "pdl1_ihc_clone",
          "value": "dako_22c3"
        },
        {
          "finding": "pdl1_assay_platform",
          "value": "dako_22c3_pharmdx"
        },
        {
          "finding": "pdl1_clone",
          "value": "22C3"
        }
      ]
    },
    {
      "any_of": [
        {
          "comparator": ">=",
          "finding": "pdl1_tps",
          "threshold": 1
        },
        {
          "comparator": ">=",
          "finding": "pdl1_cps",
          "threshold": 1
        },
        {
          "finding": "pdl1_status",
          "value": "positive"
        },
        {
          "finding": "pdl1_expression",
          "value": "positive"
        }
      ]
    }
  ],
  "type": "biomarker"
}

Нотатки

**Why clone identity matters (Blueprint PD-L1 Comparison summary):** Clone | Platform | Companion drug | Interchangeable for TPS? | Interchangeable for CPS? -------------------------------------------------------------- 22C3 | Dako Autostainer Link 48 | pembrolizumab | reference | reference 28-8 | Dako | nivolumab | yes (TPS within 5%) | not validated for pembro-CPS thresholds SP263 | Ventana BenchMark | durvalumab / atezolizumab (some) | yes (TPS within 5%) | not validated for pembro-CPS thresholds SP142 | Ventana | atezolizumab | NO — under-stains tumor cells, separate "IC%" score | NO **Indication-specific 22C3 cut-points (pembrolizumab):** - NSCLC 1L mono: TPS ≥50 (KEYNOTE-024) - NSCLC 1L combo eligibility: TPS ≥1 (KEYNOTE-189 / -407) - Gastric / GEJ adeno 1L combo: CPS ≥1 (KEYNOTE-859); FDA pivot to ≥5 in subgroups (label evolution 2024) - Esophageal squamous 1L combo: CPS ≥10 (KEYNOTE-590) - TNBC 1L combo: CPS ≥10 (KEYNOTE-355) - Cervical 1L combo: CPS ≥1 (KEYNOTE-826) - H&N squamous 1L: CPS ≥1 (KEYNOTE-048 mono); CPS ≥20 mono- superior subgroup - Urothelial 1L: CPS ≥10 (KEYNOTE-052 cisplatin-ineligible); label evolution 2024 narrowed mono use **Action when this RF fires:**...

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