iRECISTの概要 - 株式会社マイクロン

1 IRECIST Molecular Imaging CRO Network Micron s ViewPoint iRECIST iRECIST Micron s ViewPoint 2 iRECSIT irRC irRECIST iRECIST iRECIST iCPD iUPD iBOR iPD date 3 3 4 5 6 7 8 10 13 14 iRECIST Micron s ViewPoint 3 iRECIST QOL EORTC RECIST 2000 RECIST Response Evaluation Criteria in Solid Tumors 2009 RECIST flare effect PD irRC 2009 irRECIST 2014 irRC WHO irRECIST RECIST modify RECIST 2017 iRECIST iRECIST RECIST iRECIST iRECIST RECIST iRECIST

2 IRECIST 1 EORTC 2017 iRECIST EORTC iRECIST Micron s ViewPoint 4 irRC irRECIST iRECIST irRC irRECIST RECIST iRECIST BL 5mm 5mm 10mm 10mm 10mm BL 10 5 5 2 5 2 5 2 TTB TTB TTB CR PR BL TTB 50% SD PR PD PD TTB Nadir 25% CR PR BL TTB 30% SD PR PD PD Nadir TTB 20% 5mm CR PR BL TTB 30% SD PR PD PD Nadir TTB 20% 5mm CR PR BL TTB 30% SD PR PD PD Nadir TTB 20% 5mm PD PD 4 PD 12 4-8 BL TTB iUPD :baseline :total tumor burden :immune unconfirmed PD iRECIST Micron s ViewPoint 5 iRECIST CR PR SD CR PR PD iRECIST - PD PD PD PD - iUPD iCPD PD iCPD iUPD iCPD iUPD iUPD iCPD :immune unconfirmed PD :immune confirmed PD iRECIST Micron s ViewPoint 6 iCPD TP1 TP2 20% 5mm 5mm NLT 5mm NLNT NL iUPD iCPD TP NL NLT NLNT :time point :new lesion :new lesion target.

3 New lesion non-target TP1 TP2 iCPD 20% 5mm 20% 5mm 20% 5mm iUPD TP2 Nadir 20% 5mm TP2 iCPD 2 TP1 TP1 iRECIST Micron s ViewPoint 7 iUPD iCPD BL iUPD Nadir 20% 5mm iCPD iUPD iUPD iSD iPR iCR iUPD iUPD BL TP1 TP2 TP3 TP4 iUPD iPR iUPD iCPD iSD iPR iCR iCPD iUPD Nadir 20% 5mm BL TP1 TP2 TP3 TP4 iUPD iUPD iSD iUPD 10mm 0mm 20mm 10mm 0mm 20mm iRECIST Micron s ViewPoint 8 iBOR iCR/iPR iCR/iPR iUPD NE NE iBOR iCR > iPR > iSD=Non-iCR/non-iUPD > iCPD > iUPD > NE TP1 TP2 TP3 TP4 TP5 iBOR 1 iCR iCR iPR iUPD NE iCR iPR iUPD NE iUPD iCPD iCR 2 iUPD iPR iSD NE iCR iCR iUPD NE iCR iPR iSD iUPD iCPD NE iCR 3 iUPD iPR iPR iSD iUPD NE iPR iSD iUPD NE iCPD iPR iSD iUPD NE iCPD iPR 4 iUPD iSD NE iPR iPR iSD iUPD NE iPR iSD iUPD iCPD NE iPR 5 iUPD iSD iSD iUPD NE iSD iUPD iCPD NE iSD iUPD iCPD NE iSD 6 iUPD iCPD iCPD 7 iUPD iUPD iCPD iCPD 8 iUPD NE NE NE NE iUPD *iCR iPR iCR Non-iCR/non-iUPD iBOR.

4 Immune best overall response 1 iRECIST Micron s ViewPoint 9 iPD date TP1 TP2 TP3 iUPD iCPD - iUPD iCPD iUPD TP1 iUPD iUPD iCPD iUPD iCPD iUPD TP1 iUPD iSD iPR iCR iSD iPR iCR iUPD iSD iPR iCR iUPD iUPD iUPD - - TP2 TP3 iUPD iPFS iPD date iUPD iCPD iUPD iUPD iSD iPR iCR iUPD iUPD iCPD iSD iPR iCR iUPD * (PS iUPD iCPD iPFS :immune progression free survival iRECIST Micron s ViewPoint 10 BL TP1 TP2 TP3 Sum of diameters mm 100 130 125 120 Target response - iUPD iUPD iUPD Non-target response - Non-iCR/Non-iUPD Non-iCR/Non-iUPD iUPD New lesion Target - - - - Non-target - - - - Overall response - iUPD iUPD iCPD iPD date - - - iBOR iCPD TP2 iUPD TP3 iCPD BL TP1 TP2 Sum of diameters mm 100 130 100 Target response - iUPD iSD Non-target response - Non-iCR/Non-iUPD Non-iCR/Non-iUPD New lesion Target - - 24mm Non-target - - Overall response - iUPD iCPD iPD date - - iBOR iCPD TP1 iUPD TP2 iSD iCPD iRECIST Micron s ViewPoint 11 Case 3 BL TP1 TP2 Sum of diameters mm 100 130 110 Target response - iUPD iSD Non-target response - Non-iCR/Non-iUPD Non-iCR/Non-iUPD New lesion Target - 14mm 24mm Non-target - - - Overall response - iUPD iCPD iPD)

5 Date - - iBOR iCPD TP1 iUPD TP2 TP1 5mm iCPD Case 4 BL TP1 TP2 TP3 TP4 Sum of diameters mm 100 50 50 75 NE Target response - iPR iPR iUPD NE Non-target response - Non-iCR/Non-iUPD Non-iCR/Non-iUPD Non-iCR/Non-iUPD NE New lesion Target - - - - NE Non-target - - - NE Overall response - iPR iPR iUPD NE iPD date - - - - iBOR iPR TP5 NE TP3 iRECIST Micron s ViewPoint 12 Case 5 BL TP1 TP2 TP3 TP4 TP5 Sum of diameters mm 100 130 60 71 75 78 Target response - iUPD iPR iSD iUPD iUPD Non-target response - Non-iCR/Non-iUPD Non-iCR/Non-iUPD Non-iCR/Non-iUPD Non-iCR/Non-iUPD Non-iCR/Non-iUPD New lesion Target - 14mm 12mm 10mm 14mm 14mm Non-target - - - - Overall response - iUPD iPR iSD iUPD iCPD iPD date - - - - - iBOR iPR TP2 PD iPR TP4 iUPD TP5 iCPD TP1 iUPD TP2 iPR TP1 TP4 iRECIST Micron s ViewPoint 13 PD / iUPD/iCPD iCPD iRECIST iRECIST iRECIST Lesley Seymour, MD, et al.

6 IRECIST: guidelines for response criteria for use in trials testing immunotherapeutics. Lancet Oncol. 2017 March ; 18(3): e143 e152. A guideline for data management and data collection for trials testing immunotherapeutics. Immunotherapy: Criteria of Assessment with Imaging. iRECIST, irRECIST, irRC, Eisenhauera, et al. New response evaluation criteria in solid tumours: Revised RECIST guideline (version ). Eur J Cancer2009; 45:228 247 JD, Hoos A, O Day S, et al. Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Cancer Res. 2009; 15:7412 20. O, Ludajic K, Hoos A. Adaptation of the immune-related response criteria: irRECIST. Ann Oncol. 2014; 25(suppl 4):iv361, iv372. iRECIST Micron s ViewPoint 14 Email : 103-0027 5 3 4 : 532-0003 5-36 6 : 474-8511 430 2 PET PET PET PET GMP c-GMP 1 irRC irRECIST iRECIST EORTC iRECIST iRECIST