PD-L1 IHC — clone Ventana SP263
Vue déterministe de l'entité source de la LJAM. L'autorité clinique demeure avec les ID de la source cités et l'état d'approbation de l ́examinateur.
| ID | BIO-PDL1-SP263-CLONE |
|---|---|
| Type | Biomarqueur |
| Alias | PD-L1 SP263 (Ventana)PD-L1 ІГХ — клон Ventana SP263SP263VENTANA PD-L1 (SP263)Ventana SP263 |
| État | reviewed 2026-04-29 | pending_clinical_signoff |
| Maladies | Aucune déclaration |
| Sources | SRC-CASPIAN-PAZ-ARES-2019 SRC-NCCN-NSCLC-2025 SRC-NCCN-SCLC-2025 |
Données biomarqueurs
| Type de biomarqueur | protein_expression_ihc |
|---|---|
| Mesure | MéthodeIHC 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). UnitésTC% (% cellules tumorales avec coloration membraneuse PD-L1) Échelle type
|
| Biomarqueurs connexes | BIO-PDL1-EXPRESSION BIO-PDL1-TPS |
Notes
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.
Utilisé par
No reverse references found in the YAML corpus.