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© MediPaper 2016 ASCO 2016 Nivolumab Biomarker Data MediPaper DrugStudyPhaseDiseaseAntibodyPD-L1 Cut-off NivolumabCheckMate 012; CheckMate 017; CheckMate.

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Presentation on theme: "© MediPaper 2016 ASCO 2016 Nivolumab Biomarker Data MediPaper DrugStudyPhaseDiseaseAntibodyPD-L1 Cut-off NivolumabCheckMate 012; CheckMate 017; CheckMate."— Presentation transcript:

1 © MediPaper 2016 ASCO 2016 Nivolumab Biomarker Data MediPaper DrugStudyPhaseDiseaseAntibodyPD-L1 Cut-off NivolumabCheckMate 012; CheckMate 017; CheckMate 057 I; III; IIIAdv. NSCLC; Adv. SQ-NSCLC; Adv. NS-NSCLC Dako clone 28–8 Antibody IHC assay with EnVision FLEX visualization system on Autostainer Link 48 < 1% ≧ 1% ≧ 50% CheckMate 032I/IIRec. SCLCDako clone 28–8 Antibody IHC assay with EnVision FLEX visualization system on Autostainer Link 48 ≧ 1% < 1% CheckMate 064; CheckMate 067 II; IIIAdv. MelanomaDako clone 28–8 Antibody IHC assay with EnVision FLEX visualization system on Autostainer Link 48 ≧ 5% < 5% Abbreviations: Adv. = advanced; IHC = immunohistochemistry; NSCLC = non-small cell lung cancer; NS-NSCLC = non-squamous non- small cell lung cancer; Rec. = recurrent; SCLC = small cell lung cancer; SQ-NSCLC = squamous cell non-small cell lung cancer.

2 © MediPaper 2016 ASCO 2016 Pembrolizumab Biomarker Data DrugStudyPhaseDiseaseAntibodyPD-L1 Cut-off Pembrolizumab Keynote-006IIIAdv. MelanomaDako 22C3 Antibody IHC assay with EnVision FLEX visualization system on Autostainer Link 48 PDL1- (< 1%) PDL1+ ( ≧ 1%) Keynote-0011bAdv. NSCLCDako 22C3 Antibody IHC assay with EnVision FLEX visualization system on Autostainer Link 48 TPS < 1% TPS 1-24% TPS 25-49% TPS ≧ 50% Keynote-010IIIAdv. NSCLCDako 22C3 Antibody IHC assay with EnVision FLEX visualization system on Autostainer Link 48 TPS < 1% TPS 1-24% TPS 25-49% TPS 50-74% TPS ≧ 75% Keynote-012IRec./Met. HNSCC Dako 22C3 Antibody IHC assay with EnVision FLEX visualization system on Autostainer Link 48 TC PDL1- (<1%) TC PDL1+ ( ≧ 1%) TCIC PDL1- (<1%) TCIC PDL1+ ( ≧ 1%) Abbreviations: Adv. = advanced; HNSCC = head and neck squamous carcinoma; IC = immune cells; IHC = immunohistochemistry; Met. = metastatic; NSCLC = non-small cell lung cancer; Rec. = recurrent; SQ-NSCLC = squamous cell non-small cell lung cancer; TC = tumour cells; TPS = tumour proportion score. MediPaper

3 © MediPaper 2016 ASCO 2016 Atezolizumab Biomarker Data DrugStudyPhaseDiseaseAntibodyPD-L1 Cut-off AtezolizumabPOPLAR IMvigor210 II2L/3L NSCLC & mUCC Ventana SP142 IHC with OptiView DAB IHC Detection Kit and OptiView Amplification Kit IC3 ( ≧ 10%) IC2 ( ≧ 5% < 10%) IC1 ( ≧ 1% < 5%) IC0 (<1%) TC3 ( ≧ 50%) TC2 ( ≧ 5%<50%) TC1 ( ≧ 1% < 5%) TC0 (<1%) Abbreviations: 2L/3L = second-/third-line; Adv. = advanced; IC = immune cells; IHC = immunohistochemistry; mUCC = metastatic urothelial cell carcinoma; NSCLC = non-small cell lung cancer; TC = tumour cells. MediPaper

4 © MediPaper 2016 ASCO 2016 Durvalumab Biomarker Data DrugStudyPhaseDiseaseAntibodyPD-L1 Cut-off DurvalumabAdvanced Solid Tumor Trial I/IImUCC & NSCLCVentana SP263 with OptiView DAB IHC Detection Kit and OptiView Amplification Kit TC- (<25%) TC+ ( ≧ 25%) IC- (<25%) IC+ ( ≧ 25%) PD-L1-* PD-L1+* Abbreviations: IC = immune cells; IHC = immunohistochemistry; mUCC = metastatic urothelial cell carcinoma; NSCLC = non-small cell lung cancer; TC = tumour cells. *PD-L1- (<25% of TC or IC PD-L1 staining) *PD-L1+ ( ≧ 25% of TC or IC PD-L1 staining) MediPaper

5 © MediPaper 2016 ASCO 2016 Avelumab Biomarker Data DrugStudyPhaseDiseaseAntibodyPD-L1 Cut-off AvelumabJAVELIN Merkel 200 IIMCCIHC by DAKO/Agilent (NR) PDL1- (NR) PDL1+ (NR) JAVELIN Solid Tumor Trial IbSolid TumorsIHC by DAKO/Agilent (NR)PDL1- (< 1%) PDL1+ ( ≧ 1%) Abbreviations: IHC = immunohistochemistry; MCC = Merkel cell carcinoma; NR = not reported. MediPaper

6 © MediPaper 2016 ASCO 2016 Nivolumab Biomarker Data Courtesy of MediPaper Medical Writers - Medi-Paper.comMedi-Paper.com DrugStudyPhaseDiseaseAntibodyPD-L1 Cut-off NivolumabCheckMate 012; CheckMate 017; CheckMate 057 I; III; IIIAdv. NSCLC; Adv. SQ-NSCLC; Adv. NS-NSCLC Dako clone 28–8 Antibody IHC assay with EnVision FLEX visualization system on Autostainer Link 48 < 1% ≧ 1% ≧ 50% CheckMate 032I/IIRec. SCLCDako clone 28–8 Antibody IHC assay with EnVision FLEX visualization system on Autostainer Link 48 ≧ 1% < 1% CheckMate 064; CheckMate 067 II; IIIAdv. MelanomaDako clone 28–8 Antibody IHC assay with EnVision FLEX visualization system on Autostainer Link 48 ≧ 5% < 5% Abbreviations: Adv. = advanced; IHC = immunohistochemistry; NSCLC = non-small cell lung cancer; NS-NSCLC = non-squamous non- small cell lung cancer; Rec. = recurrent; SCLC = small cell lung cancer; SQ-NSCLC = squamous cell non-small cell lung cancer.

7 © MediPaper 2016 ASCO 2016 Pembrolizumab Biomarker Data Courtesy of MediPaper Medical Writers - Medi-Paper.comMedi-Paper.com DrugStudyPhaseDiseaseAntibodyPD-L1 Cut-off Pembrolizumab Keynote-006IIIAdv. MelanomaDako 22C3 Antibody IHC assay with EnVision FLEX visualization system on Autostainer Link 48 PDL1- (< 1%) PDL1+ ( ≧ 1%) Keynote-0011bAdv. NSCLCDako 22C3 Antibody IHC assay with EnVision FLEX visualization system on Autostainer Link 48 TPS < 1% TPS 1-24% TPS 25-49% TPS ≧ 50% Keynote-010IIIAdv. NSCLCDako 22C3 Antibody IHC assay with EnVision FLEX visualization system on Autostainer Link 48 TPS < 1% TPS 1-24% TPS 25-49% TPS 50-74% TPS ≧ 75% Keynote-012IRec./Met. HNSCCDako 22C3 Antibody IHC assay with EnVision FLEX visualization system on Autostainer Link 48 TC PDL1- (<1%) TC PDL1+ ( ≧ 1%) TCIC PDL1- (<1%) TCIC PDL1+ ( ≧ 1%) Abbreviations: Adv. = advanced; HNSCC = head and neck squamous carcinoma; IC = immune cells; IHC = immunohistochemistry; Met. = metastatic; NSCLC = non-small cell lung cancer; Rec. = recurrent; SQ-NSCLC = squamous cell non-small cell lung cancer; TC = tumour cells; TPS = tumour proportion score.

8 © MediPaper 2016 ASCO 2016 Atezolizumab Biomarker Data DrugStudyPhaseDiseaseAntibodyPD-L1 Cut-off AtezolizumabPOPLAR IMvigor210 II2L/3L NSCLC & mUCC Ventana SP142 IHC with OptiView DAB IHC Detection Kit and OptiView Amplification Kit IC3 ( ≧ 10%) IC2 ( ≧ 5% < 10%) IC1 ( ≧ 1% < 5%) IC0 (<1%) TC3 ( ≧ 50%) TC2 ( ≧ 5%<50%) TC1 ( ≧ 1% < 5%) TC0 (<1%) Abbreviations: 2L/3L = second-/third-line; Adv. = advanced; IC = immune cells; IHC = immunohistochemistry; mUCC = metastatic urothelial cell carcinoma; NSCLC = non-small cell lung cancer; TC = tumour cells. Courtesy of MediPaper Medical Writers - Medi-Paper.comMedi-Paper.com

9 © MediPaper 2016 ASCO 2016 Durvalumab Biomarker Data Courtesy of MediPaper Medical Writers - Medi-Paper.comMedi-Paper.com DrugStudyPhaseDiseaseAntibodyPD-L1 Cut-off DurvalumabAdvanced Solid Tumor Trial I/IImUCC & NSCLCVentana SP263 with OptiView DAB IHC Detection Kit and OptiView Amplification Kit TC- (<25%) TC+ ( ≧ 25%) IC- (<25%) IC+ ( ≧ 25%) PD-L1-* PD-L1+* Abbreviations: IC = immune cells; IHC = immunohistochemistry; mUCC = metastatic urothelial cell carcinoma; NSCLC = non-small cell lung cancer; TC = tumour cells. PD-L1- (<25% of TC or IC PD-L1 staining) PD-L1+ ( ≧ 25% of TC or IC PD-L1 staining)

10 © MediPaper 2016 ASCO 2016 Avelumab Biomarker Data Courtesy of MediPaper Medical Writers - Medi-Paper.comMedi-Paper.com DrugStudyPhaseDiseaseAntibodyPD-L1 Cut-off AvelumabJAVELIN Merkel 200 IIMCCIHC by DAKO/Agilent (NR) PDL1- (NR) PDL1+ (NR) JAVELIN Solid Tumor Trial IbSolid TumorsIHC by DAKO/Agilent (NR) PDL1- (< 1%) PDL1+ ( ≧ 1%) Abbreviations: IHC = immunohistochemistry; MCC = Merkel cell carcinoma; NR = not reported.


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