Table 2

Best objective response assessed per irRECIST by investigator review

ResponseMSI-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 response2 (22.2)1 (7.1)03 (18.8)4 (17.4)
Partial response7 (77.7)7 (50.0)4 (66.7)10 (62.5)13 (56.5)
Stable disease04 (28.6)2 (33.3)2 (12.5)4 (17.4)
Progressive disease02 (14.3)01 (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 response24week1 (11.1)2 (14.3)03 (18.8)3 (13.0)
Partial response24week6 (66.7)6 (42.9)4 (66.7)8 (50.0)12 (52.2)
Stable disease24week2 (22.2)4 (28.6)2 (33.3)4 (25.0)6 (26.1)
Progressive disease24week02 (14.3)01 (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, months1.6 (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% CI100 (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% CI88.9 (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.