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    TEST:
    VENTANA PD-L1 (SP142) Assay

    Company:
    Roche
    Related tests:
    4d
    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, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting | Trial completion date: Sep 2029 --> Sep 2032 | Initiation date: Jun 2026 --> Mar 2027 | Trial primary completion date: Sep 2029 --> Sep 2032
    Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date
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    PD-L1 (Programmed death ligand 1)
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    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP142) Assay
    |
    Tecentriq (atezolizumab) • Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
    9d
    Primary results from EL1SSAR, a prospective phase IIIb study of first-line atezolizumab plus nab-paclitaxel therapy for patients with PD-L1-positive advanced triple-negative breast cancer. (PubMed, Breast)
    Safety and efficacy were consistent with results from IMpassion130, which enrolled a more selected population.
    P3 data • Journal
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    PD-L1 (Programmed death ligand 1)
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    PD-L1 expression
    |
    VENTANA PD-L1 (SP142) Assay
    |
    Tecentriq (atezolizumab) • albumin-bound paclitaxel
    1m
    Comparison of PD-L1 expression between biopsy specimens and surgical resection specimens in non-small cell lung cancer: a meta-analysis. (PubMed, Clin Transl Oncol)
    PD-L1 expression may differ between biopsy specimens and surgically resected specimens in patients with advanced NSCLC, even in patients who have not received neoadjuvant therapy. Consequently, PD‑L1 status evaluated from biopsy specimens should be interpreted with caution in clinical practice. In addition, the selection of PD-L1 immunohistochemistry (IHC) detection methods may also affect the evaluation results.
    Retrospective data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    VENTANA PD-L1 (SP142) Assay
    1m
    Carboplatin with or without nivolumab in metastatic triple-negative breast cancer: a randomized phase II trial. (PubMed, Nat Commun)
    Carboplatin plus nivolumab did not significantly improve PFS compared to carboplatin in patients overall; however, a trend toward improved outcomes was observed in PD-L1-positive mTNBC patients. High mutational burden, interferon-gamma signaling, early circulating tumor DNA reduction, low baseline serum thymidine kinase activity, and urea cycle dysregulation in the microbiome emerged as potential predictors of response to immune checkpoint inhibitors with platinum.
    P2 data • Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
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    PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden) • IFNG (Interferon, gamma)
    |
    PD-L1 expression • TMB-H
    |
    VENTANA PD-L1 (SP142) Assay
    |
    Opdivo (nivolumab) • carboplatin
    2ms
    Saci-IO TNBC: Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC (clinicaltrials.gov)
    P2, N=110, Recruiting, Dana-Farber Cancer Institute | Trial primary completion date: Apr 2026 --> Apr 2027
    Trial primary completion date
    |
    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 • PD-L1 negative
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP142) Assay
    |
    Keytruda (pembrolizumab) • Trodelvy (sacituzumab govitecan-hziy)
    3ms
    Sarcomatoid urothelial carcinoma with constitutive PD-L1 overexpression. (PubMed, Am J Clin Pathol)
    Our results suggest that cPD-L1 expression in most sUC occurs secondary to IL6-JAK-STAT3 and interferon α/γ signaling. This provides a biologic rationale for evaluating response to immunotherapy in this patient population.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • TP53 (Tumor protein P53) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • IL6 (Interleukin 6) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B)
    |
    PD-L1 expression • PD-L1 overexpression
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay • VENTANA PD-L1 (SP142) Assay
    3ms
    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
    |
    VENTANA PD-L1 (SP142) Assay
    |
    Tecentriq (atezolizumab)
    3ms
    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
    |
    PD-L1 expression
    |
    VENTANA PD-L1 (SP142) Assay • PD-L1 IHC 28-8 pharmDx
    |
    Opdivo (nivolumab)
    3ms
    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
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • HER-2 negative • HR negative • HER-2 negative + HR negative
    |
    VENTANA PD-L1 (SP142) Assay
    |
    Tecentriq (atezolizumab) • carboplatin • albumin-bound paclitaxel
    3ms
    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
    |
    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) • PD1-Vaxx
    4ms
    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)
    4ms
    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