Table 1.
Studies | Line of treat-ment | Type of study | Region & population | Sample (Number of patients tested PD-L1) | Male (%) | Median age (range) |
Follow-up (years) | Treatment | Top three most common adverse events | Outcomes |
---|---|---|---|---|---|---|---|---|---|---|
24
(JUPITER-02) |
1st | Prospective (phase III) |
China, Asian (100%) |
146 (130) |
124 (85) |
46 (19–72) |
2 | Toripalimab 240 mg (day 1), gemcitabine 1 g/m2 (Days 1 and 8), and cisplatin 80 mg/m2 (day 1) every 3 weeks | Leukopenia 91.1%, Anemia 88.4%, Neutropenia 85.6% | PFS |
143 (133) |
116 (81) |
51 (21–72) |
Placebo(day 1), gemcitabine 1 g/m2 (Days 1 and 8), and cisplatin 80 mg/m2 (day 1) every 3 weeks | Leukopenia 94.4%, Anemia 94.4%, Neutropenia 93.0% | ||||||
25
(RATIONALE 309) |
1st | Prospective (phase III) |
China, Asian (100%) |
131 (123) |
103 (78.6) |
50 (26–74) |
2 | Tislelizumab 200 mg (day 1), gemcitabine 1 g/m2(Days 1 and 8), and Cisplatin 80 mg/m2 (day 1) every 3 weeks | Anemia 87.8%, WBC decreased 61.8%, Neutropenia 60.3% | PFS |
132 (119) |
103 (78.0) |
50 (23–73) |
Placebo (day 1), gemcitabine 1 g/m2(Days 1 and 8), and cisplatin 80 mg/m2 (day 1) every 3 weeks | Anemia 89.4%, Nausea 70.5%, WBC decreased 61.4% | ||||||
26
(NCI-9742) |
2nd or later | Prospective (phase II) |
Hong Kong, Asian (82.2%) |
45 (42) |
35 (77.8) |
57 (37-76) |
2 | Nivolumab 3 mg/kg every 2 weeks | Fatigue 33%, Hypothyroidism 13%, AST level increased 13% | ORR |
27
(KEYNOTE-028) |
2nd or later | Prospective (phase Ib) |
Hong Kong, Asian (63.0%) |
27 | 21 (77.8) |
52 (18–68) |
2 | Pembrolizumab 10 mg/kg every 2 weeks | Rash 25.9%, Pruritus 25.9%, Pain 22.2% | OS, PFS, ORR |
28
(POLARIS-02) |
2nd or later | Prospective (phase II) |
China, Asian (100%) |
190 (182) |
158 (83.2) |
46.4 (22–71) |
2.5 | Toripalimab 3mg/kg every 2 weeks | Hypothyroidism 23.7%, Anemia 15.3%, AST increased 15.3% | ORR |
29
(KEYNOTE-122) |
2nd or later | Prospective (phase III) |
world | 117 | 98 (83.8) |
51 (42-59) |
2 | Pembrolizumab 200 mg every 3 weeks | Hypothyroidism 13.8%, Fatigue 12.1%, Rash 11.2% | OS, PFS, ORR |
116 | 95 (81.9) |
53 (46.5–61) | Capecitabine 1000 mg/m2, gemcitabine 1250 mg/m2 or docetaxel 75 mg/m2 every 3 weeks | Neutropenia 34.8%, Anemia 25.9%, Palmar-plantar erythrodysesthemia syndrome 19.6% | ||||||
30
(M7824) |
2nd or later | Prospective (phase II) |
Hong Kong, Asian (100.0%) |
38 (31) |
33 (86.8) |
54 (18–72) |
1.5 | Bintrafuspalfa 1200 mg every 2 weeks | Anemia 50%, Pruritus 36.8%, Rash 31.6% | OS, PFS, ORR |
31
(KL-A167) |
2nd or later | Prospective (phase II) |
China, Asian (100%) |
132 (127) |
109 (82.6) |
49 (26−68) | 2 | KL-A167 900mg every 2 weeks | Hypothyroidism 13.1%, WBC decrease 10.5%, AST increase 9.2% | OS, PFS, ORR |
32
(CAPTAIN) |
2nd or later | Prospective (phase II) |
China, Asian (100%) |
156 (150) |
124 (79.5) |
48 (23–71) | 2 | Camrelizumab 200mg every 2 weeks | RCEP 89.7%, Anemia 27.6%, Hypothyroidism 24.4% | OS, PFS, ORR |
33 | 2nd or later | Prospective (phase II) |
China, Asian (100%) |
40 (29) |
32 (80.0) |
49 (37–54) | 2 | Camrelizumab 200 mg every 3 weeks plus oral apatinib 250 mg daily | Hypothyroidism 68.1%, Hypertension 66.7%, Leukopenia 61.1% | PFS, ORR |
33 | 32 (23) |
24 (75.0) |
40(36–50) | Apatinib in the first 2 weeks, then camrelizumab plus apatinib. | ||||||
34 | 2nd or later | Prospective (phase II) |
China, Asian (100%) |
58 (47) |
46 (79.3) |
NA | 2 | Apatinib 250 mg daily and camrelizumab 200 mg every 3 weeks | Hypertension 70.7%, Dysphagia 69.0%, Pharyngolaryngeal pain 67.2% | PFS, ORR |
35 | 2nd or later | Prospective (phase I/II) |
China, Asian (100%) |
21 (20) |
NA | NA | 2 | Tislelizumab 200mg every 3 weeks | Anemia 7.7%, AST increase 7.7%, ALT increase 6.3% | ORR |
36 | 2nd or later | Prospective (phase II) |
China, Asian (100%) |
18 | 15 (83.3) |
47 | 2 | Famitinib 20 mg daily and camrelizumab 200 mg every 3 weeks | Neutropenia 66.7%, Albuminuria 61.1%, Leukopenia 61.1% | PFS, ORR |
PD-L1, programmed cell death ligand-1; NA, not reported; IV, intravenous injection; WBC, white blood cell; AST, aspartate aminotransferase; RCEP, reactive capillary endothelial proliferation; ALT, alanine aminotransferase.