Table 2.
Completed clinical trial of PD-1/PD-L1 inhibitors combination in R/M NPC.
| Trial | Design | Population | Treatment | ORR (%), ICI arm versus placebo arm | DCR (%), ICI arm versus placebo arm | Median PFS (months), ICI arm versus placebo arm | Median OS, ICI arm versus placebo arm | DOR (months), ICI arm versus placebo arm | 1-year PFS rate (%), ICI arm versus placebo arm |
Grade ⩾ 3 TRAEs (%) ICI arm versus placebo arm |
The most common grade ⩾ 3 TRAEs in ICI arm |
|---|---|---|---|---|---|---|---|---|---|---|---|
| JUPITER-02 | Phase III | 289 R/M NPC (1:1) without prior CT | Toripalimab 240 mg or placebo (day 1), gemcitabine 1 g/m2
(Days 1 and 8), and cisplatin 80 mg/m2 (day 1) every 3 weeks |
77.4 versus 66.4 p = 0.0335 |
87.7 versus 79.7 p = 0.0650 |
11.7 versus 8.0 p = 0.0003 |
Immature | 10.0 versus 5.7 p < 0.005 |
49.4 versus 27.9 | 89.0 versus 89.5 p > 0.05 |
Neutropenia (63.6%) Leukopenia (58.0%) |
| CAPTAIN-1st | Phase III | 263 R/M NPC (1:1) without prior CT | Camrelizumab 200 mg or placebo (day 1), gemcitabine 1 g/m2
(Days 1 and 8), and cisplatin 80 mg/m2 (day 1) every 3 weeks |
87.3 versus 80.6 p > 0.05 |
96.3 versus 94.6 p > 0.05 |
9.7 versus 6.9 p = 0.0002 |
Immature | 8·5 versus 5.6 | N/A | 94.0 versus 91.0 p > 0.05 |
Decreased WBC count (66.0%); Neutropenia (64.0%); anemia (40.0%) |
| RATIONALE 309 | Phase III | 263 R/M NPC (1:1) without prior CT | Tislelizumab 200 mg or placebo (day 1), gemcitabine 1 g/m2
(Days 1 and 8), and cisplatin 80 mg/m2 (day 1) every 3 weeks |
69.5 versus 55.3 | 89.3 versus 84.8 | 9.2 versus 7.4 p < 0.0001 |
Immature | 8.5 versus 6.1 | 35.7 versus 12.2 | 80.9 versus 81.8 | Neutropenia (30.0%); anemia (25.0%) |
| NCT03121716 | Phase I | 22 R/M NPC without prior CT | Camrelizumab 200 mg (day 1), gemcitabine 1 g/m2
(Days 1 and 8), and cisplatin 80 mg/m2 (day 1) every 3 weeks |
91.0 | 100 | NR | NA | NR | 61.0 | 13 (57.0%) | Neutropenia (53.0%); anemia (48.0%) |
CT, chemotherapy; DCR, disease control rate; DOR, duration of response; ICI, immune checkpoint inhibitors; N/A, not available; NPC, nasopharyngeal carcinoma; NR, not reached; ORR, objective response rate; OS, overall survival; PD-1, programmed death-1; PD-L1, programmed death ligand-1; PFS, progression-free survival; R/M, recurrence and/or metastatic; TRAE, treatment-related adverse effect; WBC, white blood cell.