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    TEST:
    VENTANA PD-L1 (SP263) Assay

    Company:
    Roche
    Related tests:
    1d
    A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P3, N=71, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting
    Enrollment closed
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    PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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    ALK positive • ALK fusion • ROS1 fusion • ROS1 positive
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    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay
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    Imfinzi (durvalumab) • Rozlytrek (entrectinib) • Alecensa (alectinib)
    2d
    The Correlation Among PD-L1 Expression and the Driver Genes Status in Malignant Pleural Effusion of Lung Adenocarcinoma. (PubMed, Cytopathology)
    Our findings suggest that PD-L1 immunohistochemistry is effective for evaluating pleural fluid cytological specimens and that PD-L1 expression is significantly higher in lung adenocarcinoma patients with malignant pleural effusions associated with the KRAS, ALK and BRAF mutations.
    Journal • Pleural effusion • PD(L)-1 Biomarker • IO biomarker
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    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • MET (MET proto-oncogene, receptor tyrosine kinase) • NRAS (Neuroblastoma RAS viral oncogene homolog) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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    PD-L1 expression • KRAS mutation • EGFR mutation • BRAF mutation • PIK3CA mutation • ALK mutation • MET mutation
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    VENTANA PD-L1 (SP263) Assay
    6d
    Pioneer study: a prospective, single arm, exploratory clinical study of anti-pd-1/ctla-4 combination antibody combined with bevacizumab in the treatment of non squamous non-small cell lung cancer after immune resistance (ChiCTR2500112841)
    P=N/A, N=36, Recruiting, The First Affiliated Hospital of Bengbu Medical University; The First Affiliated Hospital of Bengbu Medical University
    New trial
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    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
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    EGFR mutation • ALK translocation
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    VENTANA PD-L1 (SP263) Assay
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    Avastin (bevacizumab) • Qibeian (iparomlimab/tuvonralimab)
    14d
    Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO]) (clinicaltrials.gov)
    P3, N=1210, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Jan 2027 | Trial primary completion date: Dec 2025 --> Jan 2027
    Trial completion date • Trial primary completion date • Tumor mutational burden
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    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • gemcitabine • paclitaxel • pemetrexed
    15d
    META-1: Immunotherapy Without Chemotherapy for Advanced Lung Cancer Patients With High PD-L1 Levels (clinicaltrials.gov)
    P2, N=275, Not yet recruiting, UNICANCER
    New P2 trial • IO Companion diagnostic • PD(L)-1 companion diagnostic
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    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    ALK mutation
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay
    |
    Keytruda (pembrolizumab) • Libtayo (cemiplimab-rwlc)
    24d
    Durvalumab-containing treatment for recurrent or metastatic pulmonary sarcomatoid carcinoma: A pooled post hoc analysis of two KCSG phase II trials. (PubMed, Lung Cancer)
    Durvalumab-containing combination therapy showed promising efficacy in patients with R/M PSC, irrespective of PD-L1 expression. A lower CD4+/CD8+ ratio may be associated with favorable disease control.
    P2 data • Retrospective data • Journal • PD(L)-1 Biomarker • IO biomarker
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    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay
    |
    Imfinzi (durvalumab)
    2ms
    Correlation between F-18 FDG PET/CT-derived metabolic parameters and PD-L1 expression in non-small cell lung cancer patients. (PubMed, Rev Esp Med Nucl Imagen Mol (Engl Ed))
    Tumor heterogeneity indices, particularly HI and COV derived from FDG PET/CT, demonstrated stronger predictive value for PD-L1 expression than conventional metabolic parameters. These findings suggest that metabolic heterogeneity may serve as a useful noninvasive imaging biomarker for guiding immunotherapy in NSCLC.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • PD-L1 negative
    |
    VENTANA PD-L1 (SP263) Assay
    2ms
    Sarcomatoid carcinoma of the prostate - A single institution experience with emphasis on molecular genetic findings. (PubMed, Hum Pathol)
    This study sheds light on the molecular landscape of SCP, which may be valuable to elucidate the prognostic and therapeutic implications for this uncommon disease.
    Journal • BRCA Biomarker • PD(L)-1 Biomarker • IO biomarker
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    PD-L1 (Programmed death ligand 1) • TP53 (Tumor protein P53) • BRCA2 (Breast cancer 2, early onset) • PTEN (Phosphatase and tensin homolog) • RB1 (RB Transcriptional Corepressor 1) • CTNNB1 (Catenin (cadherin-associated protein), beta 1)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay • VENTANA PD-L1 (SP142) Assay
    3ms
    New Insights Into Succinate Dehydrogenase-Deficient Renal Cell Carcinoma. (PubMed, Arch Pathol Lab Med)
    Follow-up revealed metastasis in 1 patient, leading to mortality. Our findings broaden the morphologic spectrum and highlight a new point mutation in the SDHB gene, providing a genetic change spectrum for this tumor entity.
    Journal • PD(L)-1 Biomarker • IO biomarker
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    PD-L1 (Programmed death ligand 1) • SDHB (Succinate Dehydrogenase Complex Iron Sulfur Subunit B)
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    SDHB deficient
    |
    VENTANA PD-L1 (SP263) Assay
    3ms
    Cost-effectiveness of PD-L1 testing to guide immunotherapy for patients with advanced non-small-cell lung cancer in China. (PubMed, J Comp Eff Res)
    The VENTANA PD-L1 (SP263) Assay, which can guide multiple immune checkpoint inhibitor monotherapies (e.g., atezolizumab and pembrolizumab) for advanced NSCLC patients, achieved a higher percentage of successfully diagnosed and treated, and a higher quality-adjusted life-year at a lower cost compared with Dako PD-L1 IHC 22C3 assay and Dako 22C3 antibody concentrate. The robustness of the base case results was confirmed by both one-way sensitivity analysis and probabilistic sensitivity analysis. The VENTANA PD-L1 (SP263) Assay is cost-effective compared with Dako PD-L1 IHC 22C3 assay and Dako 22C3 antibody concentrate for the immunotherapy treatment for advanced NSCLC patients in China.
    Journal • HEOR • Cost-effectiveness
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    PD-L1 (Programmed death ligand 1)
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    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay
    |
    Keytruda (pembrolizumab) • Tecentriq (atezolizumab)
    3ms
    SKYSCRAPER-11: A Study to Evaluate the Safety and Pharmacokinetics of the Intravenous Fixed-Dose Combination (IV FDC) of Tiragolumab and Atezolizumab in Participants With Locally Advanced, Recurrent or Metastatic Solid Tumors (clinicaltrials.gov)
    P2, N=60, Active, not recruiting, Hoffmann-La Roche | Trial completion date: Sep 2025 --> Dec 2025 | Trial primary completion date: Sep 2025 --> Dec 2025
    Trial completion date • Trial primary completion date
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    VENTANA PD-L1 (SP263) Assay
    3ms
    Safety and Preliminary Efficacy Analysis of Fecal Microbiota Transplantation Combined with Platinum-Based Chemotherapy and Immune Checkpoint Inhibitors as First-Line Treatment in Patients with Advanced Driver Gene-Negative Non-Small Cell Lung Cancer (ChiCTR2500107883)
    P=N/A, N=62, Not yet recruiting, General Hospital of Ningxia Medical University; General Hospital of Ningxia Medical University
    New trial • Checkpoint inhibition
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    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    PD-L1 expression • EGFR mutation • ALK positive • RET mutation
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay