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TEST:
VENTANA PD-L1 (SP263) Assay

Company:
Roche
Related tests:
5d
Assessment of Programmed Cell Death Ligand-1 Expression in Oral Potentially Malignant Disorders and Tumor-Free Surgical Margins of Oral Squamous Cell Carcinoma: Protocol for a Retrospective Cross-Sectional Study. (PubMed, JMIR Res Protoc)
By evaluating PD-L1 expression in premalignant lesions and histologically negative margins, this study aims to identify molecular predictors of OSCC progression and survival. The findings may help establish PD-L1 as a prognostic biomarker and support its integration into precision oncology and immunotherapy strategies.
Observational data • Retrospective data • Journal • PD(L)-1 Biomarker • IO biomarker
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PD-L1 (Programmed death ligand 1)
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PD-L1 expression
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VENTANA PD-L1 (SP263) Assay
6d
Real-world effectiveness and safety of adjuvant atezolizumab in pathological stage IIA-IIIB non-small cell lung cancer following curative surgery. (PubMed, J Thorac Dis)
In this real-world cohort, adjuvant atezolizumab demonstrated favorable tolerability and clinically meaningful DFS across PD-L1 expression subgroups, including patients with PD-L1 1-49%. These findings are descriptive in nature and should be interpreted with caution, nevertheless, they provide real-world evidence supporting the potential clinical utility of adjuvant atezolizumab in appropriately selected patients with resected stage II-III NSCLC.
Journal • Real-world evidence • PD(L)-1 Biomarker • IO biomarker
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PD-L1 (Programmed death ligand 1)
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PD-L1 expression
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PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay
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Tecentriq (atezolizumab)
10d
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
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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)
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PD-L1 expression • PD-L1 overexpression
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PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay • VENTANA PD-L1 (SP142) Assay
23d
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
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cisplatin • Bavencio (avelumab) • Jakafi (ruxolitinib) • pemetrexed • roginolisib (IOA-244)
28d
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)
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PD-L1 expression
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PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay • VENTANA PD-L1 (SP142) Assay
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Tecentriq (atezolizumab) • PD1-Vaxx
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 | Trial completion date: Sep 2033 --> Jun 2030 | Trial primary completion date: Aug 2032 --> Dec 2026
Trial completion date • Trial primary completion date
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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)
2ms
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
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PD-L1 (Programmed death ligand 1)
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PD-L1 expression
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VENTANA PD-L1 (SP263) Assay
2ms
New P2/3 trial
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EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
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PD-L1 expression • EGFR mutation • ALK translocation
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PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay
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docetaxel • PF-08046054
2ms
New P2 trial
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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) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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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
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PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay
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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
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PD-L1 (Programmed death ligand 1)
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PD-L1 expression
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PD-L1 IHC 22C3 pharmDx • 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
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PD-L1 expression
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PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay
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Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab)