PD-L1 IHC — Ventana SP263 clone
Visão determinística da entidade fonte YAML. A autoridade clínica permanece com os IDs de fonte citados e estado de assinatura do revisor.
| ID | BIO-PDL1-SP263-CLONE |
|---|---|
| Tipo | Biomarcador |
| Alegais | PD-L1 SP263 (Ventana)PD-L1 ІГХ — клон Ventana SP263SP263VENTANA PD-L1 (SP263)Ventana SP263 |
| Estado | reviewed 2026-04-29 | pending_clinical_signoff |
| Doenças | Nenhuma declaração |
| Fontes | SRC-CASPIAN-PAZ-ARES-2019 SRC-NCCN-NSCLC-2025 SRC-NCCN-SCLC-2025 |
Fatos de biomarcadores
| Tipo de biomarcador | protein_expression_ihc |
|---|---|
| Medição | MétodoIHC with VENTANA PD-L1 (SP263) Assay on BenchMark ULTRA. Tumor-cell membranous staining quantified as TC% (functionally analogous to TPS). Cut-points by indication: - NSCLC PACIFIC (durvalumab consolidation post-CRT): TC ≥1% (post-hoc analysis; FDA approval not strictly cut-point-restricted but EMA limited to TC ≥1%). - NSCLC 1L durvalumab+tremelimumab+chemo (POSEIDON): not biomarker-restricted by label. - Urothelial 1L cisplatin-ineligible durvalumab (historical, now restricted). UnidadesTC% (% de células tumorais com coloração membranosa PD-L1) Gama típica
|
| Biomarcadores relacionados | BIO-PDL1-EXPRESSION BIO-PDL1-TPS |
Notas
Companion-diagnostic clone-specific entity for durvalumab. SP263 results are interchangeable with 22C3 for tumor-cell-based NSCLC cut-points (Blueprint concordance) but NOT for CPS-based scoring. TRIAL ANCHOR: PACIFIC (Antonia et al, NEJM 2017/2018) for stage III NSCLC consolidation; CASPIAN (Paz-Ares 2019) for SCLC. PACIFIC Source stub TBD (flag for source-ingest follow-up); CASPIAN already in KB.
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Não há referências reversas encontradas no corpus YAML.