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    TEST:
    VENTANA PD-L1 (SP263) Assay

    Company:
    Roche
    Related tests:
    21h
    DIONE-01: A Study to Assess a PI3Kδ Inhibitor (IOA-244) in Patients With Metastatic Cancers (clinicaltrials.gov)
    P1, N=210, Active, not recruiting, iOnctura | Trial completion date: Mar 2025 --> Mar 2027
    Trial completion date • First-in-human
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    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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    BRAF mutation • BRAF V600 • ALK translocation
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    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay
    |
    cisplatin • Bavencio (avelumab) • Jakafi (ruxolitinib) • pemetrexed • roginolisib (IOA-244)
    6d
    IMPRINTER: A Study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy, in Adults With Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=24, Terminated, Imugene Limited | Active, not recruiting --> Terminated; Portfolio prioritization
    Trial termination
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    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay • VENTANA PD-L1 (SP142) Assay
    |
    Tecentriq (atezolizumab) • IMU-201
    25d
    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 | Trial completion date: Sep 2033 --> Jun 2030 | Trial primary completion date: Aug 2032 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    ALK positive • ALK fusion • ROS1 fusion • ROS1 positive
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay
    |
    Imfinzi (durvalumab) • Rozlytrek (entrectinib) • Alecensa (alectinib)
    1m
    Expression of Programmed Death Ligand 1 (PD-L1) in Classical Hodgkin Lymphoma- Study from a Tertiary Care Cancer Centre in South India. (PubMed, Indian J Hematol Blood Transfus)
    In our patient population we found that the PD-L1 expression in relapse/refractory lymphoma biopsy in comparison to primary diagnosis biopsy remains largely unchanged in HRS cells and in the microenvironment. This stable expression of PD-L1 expression in paired biopsies suggests that PD-L1 inhibitors can be used as second line therapy in all relapsed Classical Hodgkin lymphoma patients without PD-L1 testing.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    VENTANA PD-L1 (SP263) Assay
    1m
    C5851005: A Study to Learn About the Study Medicine Called PF-08046054/SGNPDL1V Versus Docetaxel in Adult Participants with Previously-treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-small-cell Lung Cancer (NSCLC) (2025-521281-97-00)
    P2/3, N=246, Recruiting, Pfizer Inc.
    New P2/3 trial
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • EGFR mutation • ALK translocation
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay
    |
    docetaxel • PF-08046054
    1m
    PHOENIX: QL1706 Plus Chemotherapy and Bevacizumab in AGA-Resistant, PD-L1 ≥50% Non-Squamous NSCLC (clinicaltrials.gov)
    P2, N=61, Not yet recruiting, Guangdong Association of Clinical Trials
    New P2 trial
    |
    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) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    KRAS mutation • EGFR mutation • KRAS G12C • BRAF V600 • EGFR L858R • EGFR exon 19 deletion • RET fusion • HER-2 exon 20 insertion • ROS1 fusion • KRAS G12 • HER-2 exon 20 mutation
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay
    |
    Avastin (bevacizumab) • cisplatin • carboplatin • pemetrexed • Qibeian (iparomlimab/tuvonralimab)
    2ms
    Choice of fixative affects programmed death-ligand 1 expression in cell blocks from pleural effusions with metastatic pulmonary adenocarcinoma. (PubMed, Cancer Cytopathol)
    PD-L1 ICC expression in CBs depends on the fixative and antibody used. Alcohol-based fixatives, particularly with low cutoffs, risk underestimating PD-L1 positivity, and may contribute to false-negative results. ICC protocol optimization is essential before diagnostic use.
    Journal • Pleural effusion • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay
    2ms
    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=64, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed
    Trial completion
    |
    VENTANA PD-L1 (SP263) Assay
    2ms
    Utility of various programmed death-ligand 1 (PD-L1) assays in predicting the clinical benefit of immune checkpoint inhibitors in PD-L1-expressing non-small-cell lung cancer patients: a systematic review. (PubMed, Transl Lung Cancer Res)
    From 2,239 titles, four relevant trials (N=1,364) were included: two randomized controlled trials of atezolizumab, and two retrospective studies of nivolumab. This review was limited by different patient populations, small numbers, possible inter-pathological discordance, and study heterogeneity. Evidence for nivolumab, pembrolizumab, or durvalumab remains inconclusive.
    Review • Journal • Checkpoint inhibition • IO Companion diagnostic • PD(L)-1 Biomarker • IO biomarker • PD(L)-1 companion diagnostic
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab)
    2ms
    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
    |
    PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    ALK positive • ALK fusion • ROS1 fusion • ROS1 positive
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay
    |
    Imfinzi (durvalumab) • Rozlytrek (entrectinib) • Alecensa (alectinib)
    2ms
    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
    |
    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)
    |
    PD-L1 expression • KRAS mutation • EGFR mutation • BRAF mutation • PIK3CA mutation • ALK mutation • MET mutation
    |
    VENTANA PD-L1 (SP263) Assay
    2ms
    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)
    |
    EGFR mutation • ALK translocation
    |
    VENTANA PD-L1 (SP263) Assay
    |
    Avastin (bevacizumab) • Qibeian (iparomlimab/tuvonralimab)