Table 1.
Clinical efficacy of tislelizumab in prospective clinical studies.
| Clinical studies | CTR20160872 | NCT02407990 | NCT02407990 | NCT04004221/CTR20170071 | NCT03209973 | CTR20160872 | NCT03419897 | NCT03736889 | NCT02660034 | NCT03469557 | RATIONALE 302/NCT03430843 | NCT03432598 | RATIONALE 307/NCT03594747 | RATIONALE 307 (≥65 years) |
RATIONALE 304/NCT03663205 | AdvanTIG-105/ NCT04047862 |
| Races | Chinese | 64.3% Caucasian, 28.8% Asian | Caucasian | 96% Chinese, 4% Korean | Chinese | Chinese | Global | Chinese | 89.8% Caucasian, 10.2% Asian | Chinese | Global | Chinese | Chinese | Chinese | Chinese | Global |
| Tumor type | ST | ST | UC | UC | r/r cHL | NPC | HCC | MSI-H/dMMR | ST | ESCC, G/GEJ | ESCC | NSCLC, SCLC | sq NSCLC | sq NSCLC | nsq NSCLC | ST |
| Numbers of cases | 300 | 451 | 17 | 113 | 70 | 20 | 249 | 80 | 49 | 15, 15 | 256, 256 | 37, 17 | 120, 118, 117 | 39, 52, 36 | 223, 111 | 24 |
| Therapeutic regimen | Tislelizumab monotherapy | Tislelizumab monotherapy | Tislelizumab monotherapy | Tislelizumab monotherapy | Tislelizumab monotherapy | Tislelizumab monotherapy | Tislelizumab monotherapy | Tislelizumab monotherapy | tislelizumab plus pamiparib | tislelizumab plus chemotherapy | tislelizumab, chemotherapy | tislelizumab plus chemotherapy | arm A, arm B, arm C | arm A, arm B, arm C | group A, group B | tislelizumab plus ociperlimab |
| ORR | 18.4% (41/223) | 13.3% (60/451) | 29.4% (5/17) | 24% (25/104) | 87.1% (16/70) | 20.0% (3/15) | 12.2% (31/249) | 45.9% (34/74) | 20.4% (10/49) | 46.7 (7/15), 46.7 (7/15) | 20.3%, 9.8% | 62.2% (23/37), 76.5% (13/17) | 60.0%(72/120),63.6%(75/118),51.3%(60/117) | 69.2%, 75.0%, 50.0% | 57.4%(128/223), 36.9%(41/111) | 1 PR |
| DCR | - | 44.60% | 47.1% (8/17) | 38.50% | 92.9% (65/70) | 80.0% (12/15) | NA | 71.6% (53/74) | 53.10% | 80.0% (12/15), | NA | 91.9% (34/37), | 72.5%(87/120),77.1%(91/118),68.4%(80/117) | NA | 89.2% (199/223), 81.1% (90/111) | 9 SD |
| (201/451) | (40/104) | (26/49) | 66.7% (10/15) | 88.2% (15/17) | ||||||||||||
| OS | 11.5 m | 10.3 m | NA | 9.8 m | — | — | 12.4 m | NA | 388 d | NA | 8.6 m, 6.3 m | NA, 15.6 m | NA, NA, NA | NA | NA, NA | NA |
| PFS | 2.6 m | 2.1 m | NA | 2.1 m | 31.5 m | — | 2.7 m | NA | 92 d | 10.4 m, 6.1 m | NA | -, | 7.6 m, 7.6 m, 5.5 m | 9.7 m, 9.7 m, 5.2 m | 9.7 m, 7.6 m | NA |
| Grade 1-5 TRAEs | - | 96.7% (436/451) | NA | 93.8% (106/113) | 97.1% (68/70) | 46.7% (7/15) | NA | NA | 100%(49/49) | 100% (30/30) | NA | 100% (54/54) | 100%(120/120), 99.2%(117/118), 100%(117/117) | NA | 100%(222/222), 99.1%(109/110) | 83.3% (20/24) |
| Grade 3-5 TRAEs | 39.7% (119/300) | 47.0% (212/451) | NA | 44.2% (50/113) | 31.4% (22/70) | 0 | NA | 47.5% (38/80) | — | 76.7% (23/30) | 19%, 56% | 79.6% (43/54) | 85.8%(103/120), 83.9% (99/118), 80.3% (94/117) | 84.6% (33/39), 84.6% (44/52), 82.4% (28/34) | 67.6%(150/222), 53.6% (59/110) | 8.3% (2/24) |
| Grade 5 TRAEs | 4.0% (12/300) | 3.1% (14/451) | NA | 2.7% (3/113) | 0 | 0 | 0.8% (2/249) | 0 | 0 | 3.3% (1/30) | 14%, 12% | 1.9%(1/54) | 0.8% (1/120), 1.7% (2/118), 2.6% (3/117) | NA | 1.4% (3/222), 0.9% (1/110) | 0 |
Abbreviations: ORR, overall survival rate; DCR, disease control rate; OS, overall survival; PFS, progression-free survival; TRAEs, treatment-related adverse effects; ST, solid tumors; UC, urothelial carcinoma; NA, not available; r/r cHL, relapsed or refractory classical Hodgkin lymphoma; NPC, nasopharyngeal carcinoma; HCC, hepatocellular carcinoma; MSI-H/dMMR, microsatellite instability-high/mismatch repair-deficient tumor; ESCC, esophageal squamous cell carcinoma; G/GEJ, gastric/gastroesophageal junction cancer; NSCLC, non-small cell lung cancer; SCLC, small cell lung cancer; sq, squamous; nsq, non-squamous; arm A, patients receiving tislelizumab plus paclitaxel, carboplatin; arm B, patients receiving tislelizumab plus nab-paclitaxel, carboplatin; arm C, patients receiving placebo plus paclitaxel, carboplatin; group A, tislelizumab plus chemotherapy; group B, chemotherapy alone; PR, partial remission; SD, stable disease.