Response | MSI-H/dMMR n=9 | MSS/pMMR n=14 | PD-L1* negative n=6 | PD-L1 positive n=16 | Total n=23 |
ORR, no. (%) (95% CI) | 9 (100.0) (66.4 to 100.0) | 8 (57.1) (28.9 to 82.3) | 4 (66.7) (22.3 to 95.7) | 13 (81.3) (54.4 to 96.0) | 17 (73.9) (51.6 to 89.8) |
Complete response | 2 (22.2) | 1 (7.1) | 0 | 3 (18.8) | 4 (17.4) |
Partial response | 7 (77.7) | 7 (50.0) | 4 (66.7) | 10 (62.5) | 13 (56.5) |
Stable disease | 0 | 4 (28.6) | 2 (33.3) | 2 (12.5) | 4 (17.4) |
Progressive disease | 0 | 2 (14.3) | 0 | 1 (6.3) | 2 (8.7) |
ORR24week†, no. (%) (95% CI) | 7 (77.8) (40.0 to 97.2) | 8 (57.1) (28.9 to 82.3) | 4 (66.7) (22.3 to 95.7) | 11 (68.8) (41.3 to 88.9) | 15 (65.2) (42.7 to 83.6) |
Complete response24week | 1 (11.1) | 2 (14.3) | 0 | 3 (18.8) | 3 (13.0) |
Partial response24week | 6 (66.7) | 6 (42.9) | 4 (66.7) | 8 (50.0) | 12 (52.2) |
Stable disease24week | 2 (22.2) | 4 (28.6) | 2 (33.3) | 4 (25.0) | 6 (26.1) |
Progressive disease24week | 0 | 2 (14.3) | 0 | 1 (6.3) | 2 (8.7) |
DCR, no. (%) (95% CI) | 9 (100.00) (66.4 to 100.0) | 12 (85.7) (57.2 to 98.2) | 6 (100.00) (54.1 to 100) | 15 (93.8) (69.8 to 99.8) | 21 (91.3) (72.0 to 98.9) |
Clinical benefit rate‡, no. (%) (95% CI) | 9 (100) (66.4 to 100.0) | 7 (50.0) (23.0 to 77.0) | 4 (66.7) (22.3 to 95.7) | 12 (75.0) (47.6 to 92.7) | 16 (69.6) (47.1 to 86.8) |
TTR, median, 95% CI, months | 1.6 (1.4 to 7.3) | 4.3 (1.5 to NE) | 5.1 (1.5 to NE) | 1.6 (1.4 to 4.0) | 2.8 (1.5 to 5.2) |
Probability of patients with PFS | |||||
≥6 months, % 95% CI | 100 (100 to 100) | 59.6 (28.2 to 80.9) | 80.0 (20.4 to 96.9) | 80.4 (50.6 to 93.2) | 76.7 (52.7 to 89.6) |
≥12 months, % 95% CI | 88.9 (43.3 to 98.4) | 34.1 (10.6 to 59.6) | 60.0 (12.6 to 88.2) | 59.5 (30.9 to 79.5) | 57.1 (33.6 to 75.0) |
*The PD-L1 expression was measured by Combined Positive Score, and one patient was not available for PD-L1 assessment.
†ORR24week is defined as best objective observed within 24 weeks after the treatment initiation.
‡Clinical benefit rate is defined as proportion of patients with immune-related complete response, immune-related partial response, or immune-related stable disease lasting >6 months.
DCR, disease control rate; irRECIST, immune-related Response Evaluation Criteriain Solid Tumors; MSI-H/dMMR, microsatellite instability high/ mismatch-repair deficient; MSS/pMMR, microsatellite instability stalble/mismatch-repair proficient; NE, not estimable; ORR, objective response rate; PD-L1, programmed death-ligand 1; PFS, progression-free survival; TTR, time to response.