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    BIOMARKER:

    PD-L1 expression + CD8 positive

    i
    Other names: PD-L1, CD274, HPD-L1, PD-L1, B7H1, PDL1, Programmed death ligand 1, B7-H1, B7-H, PDCD1L1, PDCD1LG1, PDCD1 Ligand 1, B7 homolog 1, CD274 Antigen, Programmed cell death 1 ligand 1, CD274 molecule, CD8, CD8A, cluster of differentiation 8, CD8a Molecule, T-Cell Surface Glycoprotein CD8 Alpha Chain, T-Lymphocyte Differentiation Antigen T8/Leu-2, CD8 Antigen, Alpha Polypeptide (P32), Leu2 T-Lymphocyte Antigen, OKT8 T-Cell Antigen, T-Cell Antigen Leu2, T Cell Co-Receptor, T8 T-Cell Antigen, CD8a Antigen
    Entrez ID:
    29126; 925
    Related biomarkers:
    Expression
    Mutation
    CNA
    Others
    11ms
    The association of PD-L1 expression and CD8-positive T cell infiltration rate with the pathological complete response after neoadjuvant treatment in HER2-positive breast cancer. (PubMed, Breast Cancer Res Treat)
    High Ki-67 index, and high CD8 cell count are strong predictors for pCR in HER2-positive breast cancer. Tumours with high Ki-67 index, high TILs and CD8 infiltration may represent a subgroup where standard therapies are adequate. Conversely, those with low TILs and CD8 infiltration may identify a subgroup where use of novel strategies, including those that increase CD8 infiltration could be applied.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8)
    |
    PD-L1 expression • HER-2 positive • CD8 positive • CD8-H • PD-L1 expression + CD8 positive
    over1year
    daNIS-1: Study of Efficacy and Safety of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) (clinicaltrials.gov)
    P2, N=151, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Nov 2023 --> Apr 2024 | Trial primary completion date: Nov 2023 --> Apr 2024
    Trial completion date • Trial primary completion date • Combination therapy • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8)
    |
    PD-L1 expression • PD-L1 expression + CD8 positive
    |
    gemcitabine • albumin-bound paclitaxel • spartalizumab (PDR001) • nisevokitug (NIS793)
    over1year
    Phase I trial of KN046, a novel bispecific antibody targeting PD-L1 and CTLA-4 in patients with advanced solid tumors. (PubMed, J Immunother Cancer)
    KN046 was well tolerated and showed promising antitumor efficacy in advanced solid tumors, especially in patients with NPC. The combination of both CD8 and PD-L1 expression improved the prediction of KN046 response.
    P1 data • Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    EGFR (Epidermal growth factor receptor) • CD8 (cluster of differentiation 8) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    PD-L1 expression • EGFR mutation • CD8-H • PD-L1 expression + CD8 positive
    |
    erfonrilimab (KN046)
    almost2years
    PD-L1 expression and CD8 positive lymphocytes in human neoplasms: A tissue microarray study on 11,838 tumor samples. (PubMed, Cancer Biomark)
    PD-L1 expression in tumor and inflammatory cells is found in a wide range of human tumor types. Higher rates of tumor infiltrating CD8 positive lymphocytes in PD-L1 positive than in PD-L1 negative cancers suggest that the antitumor immune response may trigger tumoral PD-L1 expression.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8)
    |
    PD-L1 expression • PD-L1 negative • CD8 positive • PD-L1 expression + CD8 positive
    almost2years
    daNIS-1: Study of Efficacy and Safety of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) (clinicaltrials.gov)
    P2, N=161, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8)
    |
    PD-L1 expression • PD-L1 expression + CD8 positive
    |
    gemcitabine • albumin-bound paclitaxel • spartalizumab (PDR001) • nisevokitug (NIS793)
    2years
    Escherichia coli-specific CXCL13-producing TFH are associated with clinical efficacy of neoadjuvant PD-1 blockade against muscle-invasive bladder cancer. (PubMed, Cancer Discov)
    Profiling tumor and blood samples, we found that follicular helper CD4+ T cells (TFH) are among the best therapeutic targets of pembrolizumab correlating with progression-free survival...Finally, TFH and IgG directed against urothelium invasive Escherichia coli dictated clinical responses to pembrolizumab in three independent cohorts. The links between tumor infection and success of ICB immunomodulation should be prospectively assessed at a larger scale.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • CD38 (CD38 Molecule) • CD4 (CD4 Molecule) • CXCL13 (Chemokine (C-X-C motif) ligand 13)
    |
    PD-L1 expression • PD-L1 expression + CD8 positive
    |
    Keytruda (pembrolizumab)
    2years
    Immune biomarker analysis of RP1 in combination with nivolumab in patients with advanced solid tumors (SITC 2022)
    A notable reversal of CD8 T cell exclusion was observed in a melanoma patient who failed prior ipilimumab and nivo treatment. The data indicate the potential for broad utility of RP1 in a range of tumor types, including in patients with primary or acquired resistance to immune checkpoint blockade. Trial Registration NCT03767348
    Combination therapy • Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • CXCL9 (Chemokine (C-X-C motif) ligand 9) • CD27 (CD27 Molecule) • CSF2 (Colony stimulating factor 2) • TRB (T Cell Receptor Beta Locus)
    |
    PD-L1 expression • CSF2 expression • PD-L1 expression + CD8 positive
    |
    PD-L1 IHC 28-8 pharmDx • nCounter® PanCancer IO 360™ Panel
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • vusolimogene oderparepvec (RP1)
    over2years
    Immune Profile of BRAF-Mutated Metastatic Colorectal Tumors with Good Prognosis after Palliative Chemotherapy. (PubMed, Cancers (Basel))
    The clinical outcomes of unselected patients with BRAF-MT CRC were generally similar to those in previous studies. Based on the immune profile analysis, higher PD-L1 expression and CD8-positive cell infiltration were observed in BRAF-MT tumors with a good prognosis.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1)
    |
    PD-L1 expression • BRAF mutation • CD8 positive • PD-L1 expression + CD8 positive
    over2years
    daNIS-1: Study of Efficacy and Safety of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) (clinicaltrials.gov)
    P2, N=161, Recruiting, Novartis Pharmaceuticals | Trial completion date: May 2023 --> Oct 2023 | Trial primary completion date: May 2023 --> Oct 2023
    Trial completion date • Trial primary completion date • Combination therapy • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8)
    |
    PD-L1 expression • PD-L1 expression + CD8 positive
    |
    gemcitabine • albumin-bound paclitaxel • spartalizumab (PDR001) • nisevokitug (NIS793)
    almost3years
    Clinical biomarker studies with an enhanced potency oncolytic HSV expressing an anti-CTLA-4 antibody, as a single agent and combined with nivolumab in patients with advanced solid tumors indicates potent immune activation. (AACR 2022)
    A particularly striking change was observed in a biopsy obtained from a liver lesion from a tebantafusp and ipi/pembro-failed uveal melanoma patient. The biomarker data presented indicates broad immune activation by RP2 and demonstrates that clinical response does not correlate with baseline PD-L1 and CD8 expression status. Clinical responses were often associated with increases in gene signatures associated with cytotoxic T, NK and Th1 cells. These data indicate the potential for broad utility of RP2 in a range of tumor types, including in patients with primary or acquired resistance to immune checkpoint blockade.
    Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • IDO1 (Indoleamine 2,3-dioxygenase 1) • CD68 (CD68 Molecule) • CSF2 (Colony stimulating factor 2) • FOXP3 (Forkhead Box P3) • TRB (T Cell Receptor Beta Locus)
    |
    PD-L1 expression • CSF2 expression • CTLA4 expression • PD-L1 expression + CD8 positive • FOXP3 expression
    |
    nCounter® PanCancer IO 360™ Panel
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • RP2
    almost3years
    An exploration of immunohistochemistry-based prognostic markers in patients undergoing curative resections for colon cancer. (PubMed, BMC Cancer)
    In tumour cells, expression of HLA-G and loss of CDX2 expression were associated with cancer recurrence. In addition, a combination of certain tumour tissue biomarkers was associated with colorectal cancer recurrence.
    Clinical • Retrospective data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • CDX2 (Caudal Type Homeobox 2)
    |
    PD-L1 overexpression • CD8 positive • CDX-2 expression • PD-L1 expression + CD8 positive
    3years
    daNIS-1: Study of Efficacy and Safety of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) (clinicaltrials.gov)
    P2, N=161, Recruiting, Novartis Pharmaceuticals | Trial completion date: Jan 2023 --> May 2023 | Trial primary completion date: Jan 2023 --> May 2023
    Clinical • Trial completion date • Trial primary completion date • Combination therapy • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8)
    |
    PD-L1 expression • PD-L1 expression + CD8 positive
    |
    gemcitabine • albumin-bound paclitaxel • spartalizumab (PDR001) • nisevokitug (NIS793)