Antagonist antibodies to PD-1 and B7-H1 (PD-L1) in the treatment of advanced human cancer.

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Published in Clin Cancer Res on March 01, 2013


Mario Sznol1, Lieping Chen

Author Affiliations

1: Department of Medicine and Immunobiology, Yale Comprehensive Cancer Center, Yale University School of Medicine, New Haven, Connecticut 06520, USA.

Associated clinical trials:

A Phase 1 Study of Nivolumab (BMS-936558) in Subjects With Advanced or Recurrent Malignancies (MDX1106-03) | NCT00730639

Study of Pembrolizumab (MK-3475) in Participants With Progressive Locally Advanced or Metastatic Carcinoma, Melanoma, or Non-small Cell Lung Carcinoma (P07990/MK-3475-001/KEYNOTE-001) (KEYNOTE-001) | NCT01295827

Multiple Ascending Dose (MDX1105-01) (Anti-PDL1) | NCT00729664

BMS-936558 (MDX-1106) In Subjects With Advanced/Metastatic Clear-Cell Renal Cell Carcinoma (RCC) | NCT01354431

A Phase 1 Study of Atezolizumab (an Engineered Anti-PDL1 Antibody) in Patients With Locally Advanced or Metastatic Solid Tumors | NCT01375842

Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) (CheckMate 017) | NCT01642004

Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Metastatic Non-squamous NSCLC (CheckMate057) | NCT01673867

Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced or Metastatic Clear-cell Renal Cell Carcinoma (CheckMate 025) | NCT01668784

Study of Nivolumab (BMS-936558) in Combination With Gemcitabine/Cisplatin, Pemetrexed/Cisplatin, Carboplatin/Paclitaxel, Bevacizumab Maintenance, Erlotinib, Ipilimumab or as Monotherapy in Subjects With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) (CheckMate 012) | NCT01454102

Phase I Biomarker Study (BMS-936558) | NCT01358721

Dose-escalation Study of Combination BMS-936558 (MDX-1106) and Ipilimumab in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma | NCT01024231

Nivolumab (BMS-936558; MDX-1106) in Combination With Sunitinib, Pazopanib, or Ipilimumab in Subjects With Metastatic Renal Cell Carcinoma (RCC) (CheckMate 016) | NCT01472081

Safety Study of IL-21/Anti-PD-1 Combination in the Treatment of Solid Tumors | NCT01629758

Safety Study of Nivolumab by Itself or in Combination in Patients With Lymphoma or Multiple Myeloma | NCT01592370

A Phase 1b Study of Atezolizumab in Combination With Vemurafenib or Vemurafenib Plus Cobimetinib in Participants With BRAFV600-Mutation Positive Metastatic Melanoma | NCT01656642

A Phase 1/2 Study to Evaluate MEDI4736 | NCT01693562

Multiple Class I Peptides & Montanide ISA 51 VG w Escalating Doses of Anti-PD-1 ab BMS936558 | NCT01176461

A Study of Atezolizumab Administered in Combination With Bevacizumab and/or With Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors | NCT01633970

A Study to Evaluate the Effectiveness, Safety and Tolerability of Nivolumab and the Combination Nivolumab Plus Ipilimumab in Patients With Advanced Liver Cancer (CheckMate040) | NCT01658878

Vaccine Combining Multiple Class I Peptides and Montanide ISA 51VG With Escalating Doses of Anti-PD-1 Antibody Nivolumab or Ipilimumab With Nivolumab For Patients With Resected Stages IIIC/ IV Melanoma | NCT01176474

Blockade of PD-1 in Conjunction With the Dendritic Cell/AML Vaccine Following Chemotherapy Induced Remission | NCT01096602

Study to Assess the Safety, Tolerability, and Pharmacokinetics of AMP-224 in Patients With Advanced Cancer | NCT01352884

Sipuleucel-T, CT-011, and Cyclophosphamide for Advanced Prostate Cancer | NCT01420965

Blockade of PD-1 in Conjunction With the Dendritic Cell/Myeloma Vaccines Following Stem Cell Transplantation | NCT01067287

PD-1 Alone or With Dendritic Cell/Renal Cell Carcinoma Fusion Cell Vaccine | NCT01441765

PH 1 Biomarker Study of Nivolumab and Ipilimumab and Nivolumab in Combination With Ipilimumab in Advanced Melanoma (PD-1) | NCT01621490

Safety, Tolerability and Efficacy Study of the Monoclonal Antibody, CT-011, in Patients With Metastatic Melanoma | NCT01435369

CT-011 MAb in DLBCL Patients Following ASCT | NCT00532259

Monoclonal Antibody CT-011 in Combination With Rituximab in Patients With Relapsed Follicular Lymphoma | NCT00904722

Gemcitabine and CT-011 for Resected Pancreatic Cancer | NCT01313416

ONO-4538 Phase I Study in Patients With Advanced Malignant Solid Tumors in Japan | NCT00836888

Study to Evaluate the Safety, Tolerability and Efficacy of FOLFOX + CT-011 Versus FOLFOX Alone | NCT00890305

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Specific recruitment of regulatory T cells in ovarian carcinoma fosters immune privilege and predicts reduced survival. Nat Med (2004) 22.96

Phase I study of single-agent anti-programmed death-1 (MDX-1106) in refractory solid tumors: safety, clinical activity, pharmacodynamics, and immunologic correlates. J Clin Oncol (2010) 17.13

Colocalization of inflammatory response with B7-h1 expression in human melanocytic lesions supports an adaptive resistance mechanism of immune escape. Sci Transl Med (2012) 13.12

Inhibitory B7-family molecules in the tumour microenvironment. Nat Rev Immunol (2008) 8.17

Blockade of B7-H1 improves myeloid dendritic cell-mediated antitumor immunity. Nat Med (2003) 7.35

Immunostimulatory monoclonal antibodies for cancer therapy. Nat Rev Cancer (2007) 5.65

Costimulatory B7-H1 in renal cell carcinoma patients: Indicator of tumor aggressiveness and potential therapeutic target. Proc Natl Acad Sci U S A (2004) 5.13

Blockade of B7-H1 and PD-1 by monoclonal antibodies potentiates cancer therapeutic immunity. Cancer Res (2005) 4.94

B7-H1 determines accumulation and deletion of intrahepatic CD8(+) T lymphocytes. Immunity (2004) 4.60

B7-H1 blockade augments adoptive T-cell immunotherapy for squamous cell carcinoma. Cancer Res (2003) 3.96

B7-H4 expression identifies a novel suppressive macrophage population in human ovarian carcinoma. J Exp Med (2006) 3.75

Durable cancer regression off-treatment and effective reinduction therapy with an anti-PD-1 antibody. Clin Cancer Res (2012) 3.68

53BP1 is required for class switch recombination. J Cell Biol (2004) 3.57

PD-1 regulates germinal center B cell survival and the formation and affinity of long-lived plasma cells. Nat Immunol (2010) 3.51

B7-H4, a molecule of the B7 family, negatively regulates T cell immunity. Immunity (2003) 3.47

B7-H1/CD80 interaction is required for the induction and maintenance of peripheral T-cell tolerance. Blood (2010) 3.21

Interaction between B7-H1 and PD-1 determines initiation and reversal of T-cell anergy. Blood (2007) 3.00

Role of PD-1 and its ligand, B7-H1, in early fate decisions of CD8 T cells. Blood (2007) 2.93

Reciprocal differentiation and tissue-specific pathogenesis of Th1, Th2, and Th17 cells in graft-versus-host disease. Blood (2009) 2.91

Evidence for a role of the PD-1:PD-L1 pathway in immune resistance of HPV-associated head and neck squamous cell carcinoma. Cancer Res (2013) 2.81

Molecular modeling and functional mapping of B7-H1 and B7-DC uncouple costimulatory function from PD-1 interaction. J Exp Med (2003) 2.66

Cutting edge: induction of B7-H4 on APCs through IL-10: novel suppressive mode for regulatory T cells. J Immunol (2006) 2.50

B7-H1 pathway and its role in the evasion of tumor immunity. J Mol Med (Berl) (2003) 2.48

B7-H1 is a ubiquitous antiapoptotic receptor on cancer cells. Blood (2008) 2.41

In vivo costimulatory role of B7-DC in tuning T helper cell 1 and cytotoxic T lymphocyte responses. J Exp Med (2005) 2.28

Expression of the B7-related molecule B7-H1 by glioma cells: a potential mechanism of immune paralysis. Cancer Res (2003) 2.27

Interferon regulatory factor-1 is prerequisite to the constitutive expression and IFN-gamma-induced upregulation of B7-H1 (CD274). FEBS Lett (2006) 2.24

Costimulatory molecule-targeted antibody therapy of a spontaneous autoimmune disease. Nat Med (2002) 2.23

Provision of antigen and CD137 signaling breaks immunological ignorance, promoting regression of poorly immunogenic tumors. J Clin Invest (2002) 2.21

Multivalent 4-1BB binding aptamers costimulate CD8+ T cells and inhibit tumor growth in mice. J Clin Invest (2008) 2.18

B7-H1 is up-regulated in HIV infection and is a novel surrogate marker of disease progression. Blood (2002) 2.17

The new B7s: playing a pivotal role in tumor immunity. J Immunother (2007) 2.15

CD137 stimulation enhances the antilymphoma activity of anti-CD20 antibodies. Blood (2010) 2.06

Tumor-expressed B7-H1 and B7-DC in relation to PD-1+ T-cell infiltration and survival of patients with cervical carcinoma. Clin Cancer Res (2009) 2.04

Relationship between B7-H4, regulatory T cells, and patient outcome in human ovarian carcinoma. Cancer Res (2007) 2.01

Lymphatic endothelial cells induce tolerance via PD-L1 and lack of costimulation leading to high-level PD-1 expression on CD8 T cells. Blood (2012) 1.95

Stimulation of natural killer cells with a CD137-specific antibody enhances trastuzumab efficacy in xenotransplant models of breast cancer. J Clin Invest (2012) 1.92

Ex vivo expanded hematopoietic stem cells overcome the MHC barrier in allogeneic transplantation. Cell Stem Cell (2011) 1.91

Costimulating aberrant T cell responses by B7-H1 autoantibodies in rheumatoid arthritis. J Clin Invest (2003) 1.87

Cooperative B7-1/2 (CD80/CD86) and B7-DC costimulation of CD4+ T cells independent of the PD-1 receptor. J Exp Med (2003) 1.85

Genomic organization and expression analysis of B7-H4, an immune inhibitory molecule of the B7 family. J Immunol (2003) 1.82

Therapeutic effect of CD137 immunomodulation in lymphoma and its enhancement by Treg depletion. Blood (2009) 1.81

B7-H3 enhances tumor immunity in vivo by costimulating rapid clonal expansion of antigen-specific CD8+ cytolytic T cells. J Immunol (2004) 1.78

Cigarette smoke extract suppresses human dendritic cell function leading to preferential induction of Th-2 priming. J Immunol (2005) 1.75

PD-1 on dendritic cells impedes innate immunity against bacterial infection. Blood (2009) 1.74

Fine tuning the immune response through B7-H3 and B7-H4. Immunol Rev (2009) 1.72

Local expression of B7-H1 promotes organ-specific autoimmunity and transplant rejection. J Clin Invest (2004) 1.71

Costimulatory molecule B7-H1 in primary and metastatic clear cell renal cell carcinoma. Cancer (2005) 1.71

Structural and functional analysis of the costimulatory receptor programmed death-1. Immunity (2004) 1.70

Cutting edge: Expression of functional CD137 receptor by dendritic cells. J Immunol (2002) 1.70

Interferon-beta enhances monocyte and dendritic cell expression of B7-H1 (PD-L1), a strong inhibitor of autologous T-cell activation: relevance for the immune modulatory effect in multiple sclerosis. J Neuroimmunol (2004) 1.69

Retracted Cross-linking the B7 family molecule B7-DC directly activates immune functions of dendritic cells. J Exp Med (2002) 1.68

Anti-PD-1/PD-L1 therapy of human cancer: past, present, and future. J Clin Invest (2015) 1.67

CD137 is expressed in human atherosclerosis and promotes development of plaque inflammation in hypercholesterolemic mice. Circulation (2008) 1.64

Blockade of B7-H1 suppresses the development of chronic intestinal inflammation. J Immunol (2003) 1.57

Constitutive and inducible expression of b7 family of ligands by human airway epithelial cells. Am J Respir Cell Mol Biol (2005) 1.56

Cytokine-mediated disruption of lymphocyte trafficking, hemopoiesis, and induction of lymphopenia, anemia, and thrombocytopenia in anti-CD137-treated mice. J Immunol (2007) 1.52

How Ebola and Marburg viruses battle the immune system. Nat Rev Immunol (2007) 1.52

Signaling through NK cell-associated CD137 promotes both helper function for CD8+ cytolytic T cells and responsiveness to IL-2 but not cytolytic activity. J Immunol (2002) 1.51

B7 family molecules are favorably positioned at the human maternal-fetal interface. Biol Reprod (2002) 1.49

Tolerogenic maturation of liver sinusoidal endothelial cells promotes B7-homolog 1-dependent CD8+ T cell tolerance. Hepatology (2008) 1.49

Differential binding properties of B7-H1 and B7-DC to programmed death-1. Biochem Biophys Res Commun (2003) 1.49

Blockade of B7-H1 (programmed death ligand 1) enhances humoral immunity by positively regulating the generation of T follicular helper cells. J Immunol (2011) 1.47

Advances in targeting cell surface signalling molecules for immune modulation. Nat Rev Drug Discov (2013) 1.46

Administration of agonistic anti-4-1BB monoclonal antibody leads to the amelioration of experimental autoimmune encephalomyelitis. J Immunol (2002) 1.45

Microglial expression of the B7 family member B7 homolog 1 confers strong immune inhibition: implications for immune responses and autoimmunity in the CNS. J Neurosci (2005) 1.43

Neurological and behavioral abnormalities, ventricular dilatation, altered cellular functions, inflammation, and neuronal injury in brains of mice due to common, persistent, parasitic infection. J Neuroinflammation (2008) 1.41

Kupffer cell suppression of CD8+ T cells in human hepatocellular carcinoma is mediated by B7-H1/programmed death-1 interactions. Cancer Res (2009) 1.39

Tumor-induced immune suppression of in vivo effector T-cell priming is mediated by the B7-H1/PD-1 axis and transforming growth factor beta. Cancer Res (2008) 1.38

Anti-4-1BB monoclonal antibody enhances rejection of large tumor burden by promoting survival but not clonal expansion of tumor-specific CD8+ T cells. Cancer Res (2002) 1.36

B7-H1 up-regulation on myeloid dendritic cells significantly suppresses T cell immune function in patients with chronic hepatitis B. J Immunol (2007) 1.35

Cell surface signaling molecules in the control of immune responses: a tide model. Immunity (2011) 1.32

B7-H3 promotes acute and chronic allograft rejection. Eur J Immunol (2005) 1.31

Targeting CD137 enhances the efficacy of cetuximab. J Clin Invest (2014) 1.29

Does decentralisation improve human resource management in the health sector? A case study from China. Soc Sci Med (2006) 1.28

Detrimental contribution of the immuno-inhibitor B7-H1 to rabies virus encephalitis. J Immunol (2008) 1.28

Programmed death-1 concentration at the immunological synapse is determined by ligand affinity and availability. Proc Natl Acad Sci U S A (2007) 1.28

Ligation of CD137 receptor prevents and reverses established anergy of CD8+ cytolytic T lymphocytes in vivo. Blood (2003) 1.27

PD-1 ligands expressed on myeloid-derived APC in the CNS regulate T-cell responses in EAE. Eur J Immunol (2008) 1.27

Retracted Immunotherapeutic potential of B7-DC (PD-L2) cross-linking antibody in conferring antitumor immunity. Cancer Res (2004) 1.26

CD137 stimulation delivers an antigen-independent growth signal for T lymphocytes with memory phenotype. Blood (2007) 1.25

Blockade of the B7-H1/PD-1 pathway for cancer immunotherapy. Yale J Biol Med (2011) 1.23

Retracted Naturally occurring human IgM antibody that binds B7-DC and potentiates T cell stimulation by dendritic cells. J Immunol (2003) 1.21

Cutting edge: selective impairment of CD8+ T cell function in mice lacking the TNF superfamily member LIGHT. J Immunol (2002) 1.20

Modulation of dendritic cell differentiation and maturation by decoy receptor 3. J Immunol (2002) 1.20

Essential role of TNF family molecule LIGHT as a cytokine in the pathogenesis of hepatitis. J Clin Invest (2006) 1.20

Cutting edge: IFN-gamma enables APC to promote memory Th17 and abate Th1 cell development. J Immunol (2008) 1.20

B7-H5 costimulates human T cells via CD28H. Nat Commun (2013) 1.19

Fc-dependent expression of CD137 on human NK cells: insights into "agonistic" effects of anti-CD137 monoclonal antibodies. Blood (2008) 1.18

B and T lymphocyte attenuator tempers early infection immunity. J Immunol (2009) 1.18

Co-signaling molecules of the B7-CD28 family in positive and negative regulation of T lymphocyte responses. Microbes Infect (2004) 1.18

Target-dependent B7-H1 regulation contributes to clearance of central nervous system infection and dampens morbidity. J Immunol (2009) 1.18

B7-h2 is a costimulatory ligand for CD28 in human. Immunity (2011) 1.17

Renewed interest in cancer immunotherapy with the tumor necrosis factor superfamily molecules. Cancer Immunol Immunother (2005) 1.17

B7-H4-deficient mice display augmented neutrophil-mediated innate immunity. Blood (2008) 1.17

Cancer-induced immunosuppression: IL-18-elicited immunoablative NK cells. Cancer Res (2012) 1.16

Blockade of endogenous B7-H1 suppresses antibacterial protection after primary Listeria monocytogenes infection. Immunology (2007) 1.16

Blocking the monocyte chemoattractant protein-1/CCR2 chemokine pathway induces permanent survival of islet allografts through a programmed death-1 ligand-1-dependent mechanism. J Immunol (2003) 1.15