Summary of efficacy by indication (safety analysis set)
| Response category, n (%) | NSCLC (n=56) | Melanoma (n=34) | ESCC (n=26) | GC (n=24) | UC (n=22) | RCC (n=21) | NPC (n=21) | HCC (n=18) | MSI-H/ dMMR* (n=16) |
| BOR† | |||||||||
| CR | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| PR | 10 (18) | 5 (15) | 2 (8) | 4 (17) | 3 (14) | 2 (10) | 9 (43) | 3 (17) | 3 (19) |
| SD | 21 (38) | 8 (24) | 7 (27) | 3 (13) | 6 (27) | 9 (43) | 9 (43) | 7 (39) | 5 (31) |
| PD | 21 (38) | 17 (50) | 13 (50) | 9 (38) | 5 (23) | 7 (33) | 3 (14) | 8 (44) | 6 (38) |
| Unknown | 4 (7) | 4 (12) | 4 (15) | 8 (33) | 8 (36) | 3 (14) | 0 | 0 | 2 (13) |
| ORR, confirmed 95% CI | 18 8.9 to 30.4 | 15 5.0 to 31.1 | 8 0.9 to 25.1 | 17 4.7 to 37.4 | 14 2.9 to 34.9 | 10 1.2 to 30.4 | 43 21.8 to 66.0 | 17 3.6 to 41.4 | 19 4.0 to 45.6 |
| Median overall survival, months, 95% CI | NE 10.1 to NE | 11.3 6.8 to 18.0 | 4.8 3.6 to 8.4 | 4.7 2.4 to NE | 4.3 2.1 to NE | NE 8.0 to NE | NE 9.2 to NE | NE 5.5 to NE | NE 4.2 to NE |
| Probability of survival at 1 year, 95% CI | 0.6 0.4 to 0.7 | 0.4 0.2 to 0.6 | 0.2 0.1 to 0.4 | 0.4 0.2 to 0.6 | 0.3 0.1 to 0.6 | 0.7 0.5 to 0.9 | 0.6 0.3 to 0.8 | 0.6 0.4 to 0.8 | 0.7 0.4 to 0.8 |
| Median PFS, months, 95% CI | 4.0 2.1 to 8.1 | 2.3 2.1 to 6.1 | 2.2 2.0 to 4.2 | 2.2 2.0 to 4.0 | 2.1 2.0 to 4.3 | 4.1 2.1 to 10.4 | 10.4 4.2 to 10.5 | 4.0 2.1 to NE | 6.1 2.0 to NE |
| CBR‡, 95% CI | 52 38.0 to 65.3 | 35 19.7 to 53.5 | 27 11.6 to 47.8 | 25 9.8 to 46.7 | 27 10.7 to 50.2 | 52 29.8 to 74.3 | 81 58.1 to 94.6 | 50 26.0 to 74.0 | 50 24.7 to 75.3 |
| DCR, 95% CI | 55 41.5 to 68.7 | 38 22.2 to 56.4 | 35 17.2 to 55.7 | 29 12.6 to 51.1 | 41 20.7 to 63.6 | 52 29.8 to 74.3 | 86 63.7 to 97.0 | 56 30.8 to 78.5 | 50 24.7 to 75.3 |
*Cancers with centrally confirmed MSI-H/dMMR.
†Confirmed responses per RECIST V.1.1.
‡CBR was defined as the rate of patients who achieved CR, PR, or SD with a duration ≥16 weeks.
BOR, best overall response; CBR, clinical benefit rate; CR, complete response; DCR, disease control rate; dMMR, deficient mismatch repair; ESCC, esophageal squamous cell carcinoma; GC, gastric cancer; HCC, hepatocellular carcinoma; MSI-H, microsatellite instability-high; NE, not estimable; NPC, nasopharyngeal carcinoma; NSCLC, non-small cell lung cancer; ORR, objective response rate; PD, progressive disease; PR, partial response; RCC, renal cell carcinoma; RECIST, Response Evaluation In Solid Tumors; SD, stable disease; UC, urothelial bladder cancer.