-1 24 CT -2-3 1 infusion reaction 11
5 ECOG Performance Status 3-4 1 EGFRALK PD-L1 TPS50% PD-L1TPS1% EGFR ALK EGFR ALK TPS PD-L1 IHC 22C3 pharmdx 1 ECOG Performance StatusPS Score 0 1 2 50% 3 50% 4 12
ECOG Performance Status 01 1 75 ECOG Performance Status 2 1 3 3 13
6 X CT infusion reactioninfusion reaction TSH T3 T4 ASTALTγ-GTPAl-P 1 1 1 9 1 3 14
20 mg 100 mg
1. P2 2. P3 3. P4 4. P11 5. P13 6. P14 1
1 2016 28 20 mg 100 mg 1 2mg/kg 3 30 MSD 2
2 20 mg 100 mg PD-1programmed cell death-1 PD-L1 PD-L2 IgG4 PD-1 T PD-1 T PD-1 PD-L1 T PD-L1 PD-L1PD-1PD-L1 PD-1PD-L1 PD-L2 T 3
3 bkeynote-041 2 42 37 2 mg/kg 3Q3W RECIST 1.1CR PR24%95%1241 10% KEYNOTE-002 2 mg/kg Q3W 10 mg/kg Q3W ICC OSPFS PFS OS PFS *1 95%CI *2 95%CI P *3 95%CI *2 95%CI P *3 1KEYNOTE-002 2 mg/kg Q3W 180 13.4 11.0, 16.4 0.86 0.67, 1.10 0.1173 2.9 2.8, 3.8 0.57 0.45, 0.73 0.0001 4 10 mg/kg Q3W 181 14.7 11.3, 19.5 0.74 0.57, 0.96 0.0106 2.9 2.8, 4.7 0.50 0.39, 0.64 0.0001 179 11.0 8.9, 13.8 2.7 2.5, 2.8 CI*1 RECIST 1.1 *2 Cox*3
OSKaplan-Meier PFSKaplan-Meier 5
KEYNOTE-006 1 10 mg/kg Q3W 10 mg/kg 2Q2W OSPFS OS PFS OS *1 PFS *4 5 95%CI *2 95%CI P *3 95%CI *2 95%CI P *3 2 KEYNOTE-006 10 mg/kg Q3W 277 NE NE, NE 0.69 0.52, 0.90 0.00358 4.1 2.9, 6.9 0.58 0.47, 0.72 0.00001 10 mg/kg Q2W 279 NE NE, NE 0.63 0.47, 0.83 0.00052 5.5 3.4, 6.9 0.58 0.46, 0.72 0.00001 278 NE 13, NE 2.8 2.8, 2.9 CINE*1201533*2 Cox*3*4RECIST 1.1*5 201493 6
OSKaplan-Meier PFSKaplan-Meier 7
bkeynote-041 41/4297.6% 34/4281.0% 5% 3 5% SOC: System Organ Class PT: Preferred Term MedDRA ver.18.0 Grades % 2 mg/kg Q3W 42 Grades 3 34 (81.0) 8 (19.0) 4 (9.5) 0 (0.0) 3 (7.1) 0 (0.0) 5 (11.9) 0 (0.0) 3 (7.1) 0 (0.0) 3 (7.1) 0 (0.0) 6 (14.3) 0 (0.0) 6 (14.3) 0 (0.0) 3 (7.1) 0 (0.0) 12.4% 24.8% 3 7.1% 24.8% 614.3%infusion reaction 12.4% 12.4% 1 KEYNOTE-002 2 mg/kg Q3W172/17896.6%10 mg/kg Q3W178/17999.4% ICC167/17197.7% 121/17868.0%133/17974.3% 138/17180.7% 5% 8
4 5% % SOC: System Organ Class PT: Preferred Term 2 mg/kg Q3W 10 mg/kg Q3W ICC 178 179 171 MedDRA ver.18.0 Grades Grades 3 Grades Grades 3 Grades Grades 3 121 (68.0) 20 (11.2) 133 (74.3) 25 (14.0) 138 (80.7) 45 (26.3) 5 (2.8) 1 (0.6) 7 (3.9) 0 (0.0) 35 (20.5) 9 (5.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 14 (8.2) 6 (3.5) 1 (0.6) 0 (0.0) 1 (0.6) 0 (0.0) 14 (8.2) 6 (3.5) 2 (1.1) 0 (0.0) 1 (0.6) 1 (0.6) 16 (9.4) 4 (2.3) 9 (5.1) 0 (0.0) 13 (7.3) 0 (0.0) 0 (0.0) 0 (0.0) 5 (2.8) 0 (0.0) 9 (5.0) 0 (0.0) 14 (8.2) 0 (0.0) 15 (8.4) 0 (0.0) 19 (10.6) 2 (1.1) 14 (8.2) 3 (1.8) 8 (4.5) 0 (0.0) 16 (8.9) 1 (0.6) 56 (32.7) 4 (2.3) 2 (1.1) 1 (0.6) 10 (5.6) 1 (0.6) 26 (15.2) 4 (2.3) 6 (3.4) 1 (0.6) 8 (4.5) 1 (0.6) 10 (5.8) 1 (0.6) 40 (22.5) 2 (1.1) 52 (29.1) 1 (0.6) 62 (36.3) 8 (4.7) 6 (3.4) 0 (0.0) 11 (6.1) 0 (0.0) 8 (4.7) 1 (0.6) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 13 (7.6) 5 (2.9) 8 (4.5) 0 (0.0) 17 (9.5) 2 (1.1) 26 (15.2) 0 (0.0) 13 (7.3) 1 (0.6) 12 (6.7) 1 (0.6) 9 (5.3) 1 (0.6) 9 (5.1) 2 (1.1) 7 (3.9) 0 (0.0) 10 (5.8) 1 (0.6) 2 (1.1) 0 (0.0) 0 (0.0) 0 (0.0) 14 (8.2) 2 (1.2) 1 (0.6) 0 (0.0) 2 (1.1) 0 (0.0) 11 (6.4) 0 (0.0) 5 (2.8) 0 (0.0) 1 (0.6) 0 (0.0) 35 (20.5) 1 (0.6) 9 (5.1) 0 (0.0) 9 (5.0) 0 (0.0) 2 (1.2) 0 (0.0) 37 (20.8) 0 (0.0) 42 (23.5) 0 (0.0) 6 (3.5) 0 (0.0) 21 (11.8) 0 (0.0) 18 (10.1) 0 (0.0) 8 (4.7) 0 (0.0) 5 (2.8) 1 (0.6) 10 (5.6) 1 (0.6) 0 (0.0) 0 (0.0) 10 (5.6) 0 (0.0) 9 (5.0) 0 (0.0) 2 (1.2) 0 (0.0) 2 mg/kg Q3W 10 mg/kg Q3W10.6% 42.2% 10.6% 63.4% 21.1% 0 137.3% 158.4% 10.6% 10.6% 1 0.6% 31.7% 147.9% 158.4%infusion reaction 21.1% 31.7% 10.6% 10.6% 10.6% 0 0 10.6% 0 10.6% 0 21.1%1 9
KEYNOTE-006 10 mg/kg Q3W264/27795.3%10 mg/kg Q2W275/27898.9% IPI239/25693.4% 202/27772.9%221/27879.5% 187/25673.0% 5% SOC: System Organ Class PT: Preferred Term MedDRA ver.18.0 5 5% % 10 mg/kg Q3W 277 10 mg/kg Q2W 278 Grades Grades 3 Grades Grades3 Grades Grades 3 202 (72.9) 28 (10.1) 221 (79.5) 37 (13.3) 187 (73.0) 51 (19.9) 7 (2.5) 0 (0.0) 17 (6.1) 0 (0.0) 6 (2.3) 1 (0.4) 21 (7.6) 0 (0.0) 25 (9.0) 1 (0.4) 2 (0.8) 0 (0.0) 5 (1.8) 0 (0.0) 10 (3.6) 0 (0.0) 15 (5.9) 0 (0.0) 8 (2.9) 5 (1.8) 4 (1.4) 4 (1.4) 19 (7.4) 16 (6.3) 40 (14.4) 3 (1.1) 47 (16.9) 7 (2.5) 58 (22.7) 8 (3.1) 11 (4.0) 0 (0.0) 20 (7.2) 0 (0.0) 1 (0.4) 0 (0.0) 31 (11.2) 1 (0.4) 28 (10.1) 0 (0.0) 22 (8.6) 1 (0.4) 5 (1.8) 0 (0.0) 10 (3.6) 1 (0.4) 14 (5.5) 0 (0.0) 31 (11.2) 0 (0.0) 32 (11.5) 1 (0.4) 16 (6.3) 2 (0.8) 53 (19.1) 1 (0.4) 58 (20.9) 0 (0.0) 39 (15.2) 3 (1.2) 6 (2.2) 1 (0.4) 14 (5.0) 0 (0.0) 6 (2.3) 2 (0.8) 18 (6.5) 0 (0.0) 17 (6.1) 0 (0.0) 20 (7.8) 0 (0.0) 32 (11.6) 1 (0.4) 26 (9.4) 0 (0.0) 13 (5.1) 2 (0.8) 6 (2.2) 0 (0.0) 19 (6.8) 1 (0.4) 5 (2.0) 1 (0.4) 39 (14.1) 0 (0.0) 40 (14.4) 0 (0.0) 65 (25.4) 1 (0.4) 37 (13.4) 0 (0.0) 41 (14.7) 0 (0.0) 37 (14.5) 2 (0.8) 31 (11.2) 0 (0.0) 25 (9.0) 0 (0.0) 4 (1.6) 0 (0.0) IPI 256 10 mg/kg Q3W 10 mg/kg Q2W41.4% 10.4% 103.6% 134.7% 20.7% 0 145.1% 23 8.3%20.7% 10.4% 10.4% 10.4% 2810.1% 33 11.9% 10.4% 20.7%infusion reaction 72.5% 51.8%1 10.4% 0 0 10.4% 10.4% 10.4% 10.4% 0 0 10.4% 31.1% 10.4% 10
4-115 (1) 2941 434 (2) 296185 (3) (4) 1 2 28712540 (5) 287 11290-2 2 5 2 2 5 11
-1 24 CT -2-3 1 infusion reaction 12
5 ECOG Performance Status 3-4 1 BRAFBRAF 1 ECOGPerformance StatusPS Score 0 1 50% 2 3 50% 4 13
6 X CT infusion reactioninfusion reaction TSH T3 T4 ASTALTγ-GTPAl-P 1 1 1 3 1 6 14
20 mg 100 mg
1. P2 2. P3 3. P4 4. P6 5. P8 6. P9 1
1. 2016 28 20 mg 100 mg 1 200 mg3 30 MSD 2
2 20 mg 100 mg PD-1programmed cell death-1 PD-L1 PD-L2 IgG4 PD-1 T PD-1 T PD-1 PD-L1 T PD-L1 PD-L1PD-1PD-L1 PD-1PD-L1 PD-L2 T 3
3 KEYNOTE-087 210 10 3 200 mg 3 1 2 3 IWG criteria2007crpr 1 20% 1KEYNOTE-087 1 69 2 81 3 60 CR 1521.7 1822.2 1321.7 PR 3550.7 3543.2 2745.0 SD 1318.8 911.1 1321.7 % PD 34.3 1721.0 711.7 34.3 22.5 0 CRPR% 72.5 65.4 66.7 95% 60.4, 82.5 54.0, 75.7 53.3, 78.3 4
KEYNOTE-087 202/21096.2% 144/21068.6% 5% 2 2 5% SOC: System Organ Class PT: Preferred Term MedDRA/J ver.19.0 % 210 Grade Grades 3 144 (68.6) 23 (11.0) 11 (5.2) 5 (2.4) 26 (12.4) 1 (0.5) 15 (7.1) 2 (1.0) 12 (5.7) 0 (0.0) 19 (9.0) 1 (0.5) 22 (10.5) 1 (0.5) 13 (6.2) 0 (0.0) 12 (5.7) 1 (0.5) 16 (7.6) 0 (0.0) 62.9% 31.4% 10.5% 83.8% 2913.8% 21.0%Infusion reaction178.1% 21.0% 10.5% 1 5
4-1 15 (1) 2941434 (2) 296185 (3) (4) 1 2 28712540 (5) 287 11290-2 2 5 2 2 4 3 6
-1 24 CT -2-3 1 infusion reaction 7
5 ECOG Performance Status 3-4 1 1 ECOG Performance StatusPS Score 0 1 2 50% 3 50% 4 8
6 X CT infusion reactioninfusion reaction TSH T3 T4 ASTALTγ-GTPAl-P 1 1 1 12 9