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    TEST:
    VENTANA PD-L1 (SP142) Assay

    Company:
    Roche
    Related tests:
    4d
    A Study of Atezolizumab in High PD-L1 Expression, Chemotherapy-Naïve Patients With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=60, Active, not recruiting, Hoffmann-La Roche | Trial primary completion date: Dec 2026 --> Dec 2025
    Trial primary completion date • IO biomarker
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    VENTANA PD-L1 (SP142) Assay
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    Tecentriq (atezolizumab)
    6d
    Combined positive score using 28-8 predicts nivolumab efficacy in HNSCC. (PubMed, Oral Oncol)
    Clone selection is critical in PD-L1 immunohistochemistry, and 28-8-based CPS appears to be a practical biomarker for guiding nivolumab treatment in this setting.
    Journal • PD(L)-1 Biomarker • IO biomarker
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    PD-L1 expression
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    VENTANA PD-L1 (SP142) Assay • PD-L1 IHC 28-8 pharmDx
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    Opdivo (nivolumab)
    9d
    GIM25-CAPT: A Phase II trial of atezolizumab plus CArboplatin plus nab-Paclitaxel as first-line Therapy in metastatic triple-negative PD-L1 positive breast cancer patients (2024-519514-31-00)
    P1/2, N=104, Recruiting, Consorzio Oncotech | Not yet recruiting --> Recruiting
    Enrollment open
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    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
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    PD-L1 expression • HER-2 negative • HR negative • HER-2 negative + HR negative
    |
    VENTANA PD-L1 (SP142) Assay
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    Tecentriq (atezolizumab) • carboplatin • albumin-bound paclitaxel
    13d
    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
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    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay • VENTANA PD-L1 (SP142) Assay
    |
    Tecentriq (atezolizumab) • PD1-Vaxx
    27d
    A Study of Atezolizumab in High PD-L1 Expression, Chemotherapy-Naïve Patients With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=60, Active, not recruiting, Hoffmann-La Roche | Trial primary completion date: Jun 2026 --> Dec 2026
    Trial primary completion date • IO biomarker
    |
    VENTANA PD-L1 (SP142) Assay
    |
    Tecentriq (atezolizumab)
    1m
    PD-L1 expression across urothelial carcinoma subtypes: A multicenter comparison of 22C3 and SP142 for clinical decision-making in the immunotherapy era. (PubMed, Pathol Res Pract)
    The 22C3 and SP142 assays show analytical concordance for overall PD-L1 status but significant variability in IC scoring. Given the variability in PD-L1 expression across UC-s, precise characterization of both TC and IC staining per assay is crucial. These findings support incorporating UC-s subtype and assay-specific PD-L1 profiles into routine diagnostics to optimize immunotherapy decisions.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP142) Assay
    1m
    Real-world prevalence of PD-L1 positivity in early-stage/metastatic triple-negative breast cancer: primary results and pathology insights from the global retrospective observational VANESSA study. (PubMed, Histopathology)
    In this real-world study, PD-L1-positive prevalence was lower than in prospective trials assessing PD-L1 status centrally, lower in mTNBC than eTNBC, lower in smaller than larger tissue samples and lower by local than central assessment. These findings underline the importance of central PD-L1 testing on sufficiently large samples to ensure optimal selection for therapies targeting PD-(L)1 in mTNBC.
    Retrospective data • Journal • Real-world evidence • PD(L)-1 Biomarker • IO biomarker
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    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    VENTANA PD-L1 (SP142) Assay
    2ms
    SKYLINE: Tiragolumab, Atezolizumab and Chemotherapy in Triple Negative Breast Cancer (clinicaltrials.gov)
    P2, N=81, Active, not recruiting, Institut Curie | Recruiting --> Active, not recruiting | N=130 --> 81
    Enrollment closed • Enrollment change
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    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 positive • HER-2 negative • PD-L1 negative • ER negative
    |
    VENTANA PD-L1 (SP142) Assay
    |
    Tecentriq (atezolizumab) • carboplatin • doxorubicin hydrochloride • albumin-bound paclitaxel • cyclophosphamide • tiragolumab (RG6058)
    2ms
    Testing the Impact of an Anti-Cancer Drug, Atezolizumab, After Surgery to Prevent Early Stage Non-small Cell Lung Cancer From Returning, AASI-NSCLC Trial (clinicaltrials.gov)
    P3, N=336, Not yet recruiting, National Cancer Institute (NCI)
    New P3 trial
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    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP142) Assay
    |
    Tecentriq (atezolizumab) • Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
    3ms
    neoMono: Study to Compare a Mono Atezolizumab Window Followed by a Atezolizumab - CTX Therapy With Atezolizumab - CTX Therapy (clinicaltrials.gov)
    P2, N=442, Terminated, Palleos Healthcare GmbH | Completed --> Terminated; The trial stopped recruitment prematurely after a first planned interim analysis of the first 100 pCR results (given that a probability of less than 2.5% of meeting the primary endpoint was estimated).
    Trial termination
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    PD-L1 expression • HER-2 negative • ER negative
    |
    VENTANA PD-L1 (SP142) Assay
    |
    Tecentriq (atezolizumab) • carboplatin • albumin-bound paclitaxel • cyclophosphamide • epirubicin
    3ms
    Concordance of programmed death-ligand 1 expression assessments determined via two immunohistochemical tests and the polymerase chain reaction method. (PubMed, World J Exp Med)
    Thus, all three markers of PD-L1 expression are associated with the characteristics of aggressive BC, demonstrating moderate concordance between the tests.
    Journal • Polymerase Chain Reaction • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor)
    |
    PD-L1 expression • ER negative • EGFR positive
    |
    VENTANA PD-L1 (SP142) Assay
    3ms
    AZALEA: Atezolizumab and Chemotherapy Treatment as T-cell Activators in Metastatic Triple Negative Breast Cancer Patients (clinicaltrials.gov)
    P2, N=45, Recruiting, European Institute of Oncology | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    PD-L1 expression
    |
    VENTANA PD-L1 (SP142) Assay
    |
    Tecentriq (atezolizumab) • cyclophosphamide • vinorelbine tartrate