Items | KEYNOTE-028 | NCI-9742 | CheckMate-358 | JS001 | SHR-1210 (monotherapy) | GEM20110714a | SHR-1210 (combination) |
---|---|---|---|---|---|---|---|
Trial-level characteristics | |||||||
Region | Taiwan | International-collaborated | International-collaborated | Mainland China | Mainland China | Mainland China | Mainland China |
Inclusion period | 2014–2016 | 2015–2016 | 2015–2017 | 2016–2018 | 2016–2017 | 2012–2015 | 2017–2017 |
Phase | 1 | 2 | 1/2 | 2 | 1 | 3 | 1 |
Key eligibility criteria | Recurrent/metastatic NPC; Failure on prior standard therapy; PD-L1 expression ≥1% | Recurrent/metastatic NPC; Failure on at least one prior line of platinum-based chemotherapy | Recurrent/metastatic NPC; ≤ 2 prior systemic therapies | Recurrent/metastatic NPC; Failure on at least one prior line of platinum-based chemotherapy | Recurrent/metastatic NPC; Failure on at least one prior line of platinum-based chemotherapy | Treatment-naive recurrent/metastatic NPC | Treatment-naive recurrent/metastatic NPC |
Experimental regimen | Anti-PD-1: Pembrolizumab 10 mg/kg q2wks up to 2 years or until disease progression or unacceptable toxicity | Anti-PD-1: Nivolumab 3 mg/kg q2wks on a 4-week cycle until disease progression | Anti-PD-1: Nivolumab 240 mg/kg q2wks until disease progression | Anti-PD-1: JS001 3 mg/kg q2wks until disease progression or unacceptable toxicity | Anti-PD-1: Camrelizumab at escalating doses of 1, 3 and 10 mg/kg, and a bridging dose of 200 mg per dose q2wks until unacceptable toxicity | Chemotherapy: Gemcitabine 1 g/m2 (days 1 and 8), and cisplatin 80 mg/m2 (day 1) q3wks for six cycles | Anti-PD-1 + chemotherapy: Camrelizumab 200 mg (day 1), gemcitabine 1 g/m2 (days 1 and 8), cisplatin 80 mg/m2 (day 1) q3wks for six cycles followed by camrelizumab 200 mg maintenance q3wks |
Sample size | 27 | 45 | 24 | 143 | 93 | 181 | 23 |
Patient-level characteristics | |||||||
Age, median (range), years | 52 (18–68) | 57 (37–76) | 51 (NR) | 46 (24–71) | 45 (38–52) | 47 (39–55) | 44 (34–51) |
Sex, male, n (%) | 21/27 (77.8) | 35/45 (77.8) | 21/24 (88%) | 121/143 (84.6) | 75/93 (81) | 148/181 (83.1) | 17/23 (74) |
PD-L1 expressionb | |||||||
< 1%, n (%) | 0 | 24/42 (57.1) | – | 76/136 (55.9) | – | – | – |
≥ 1%, n (%) | 27/27 (100) | 18/42 (42.9) | – | 60/136 (44.1) | – | – | – |
Clinical endpoints | |||||||
Median follow-up, months | 20.0 | 12.5 | 26.0 | NR | 9.9 | 22.0 | 10.2 |
ORR (%) | 26.3 | 20.5 | 20.8 | 23.2 | 34.1 | 64.1 | 90.9 |
OS | |||||||
Median (months) | 16.5 | 17.1 | NR | NR | NR | 29.1 | NR |
1-year rate (%) | 63.0 | 59.0 | NR | NR | NR | 83.2 | NR |
PFS | |||||||
Median (months) | 6.5 | 2.8 | 2.4 | NR | 9.9 | 7.0 | 10.2 |
1-year rate (%) | 33.4 | 19.3 | NR | NR | 27.1 | 19.6 | 61.4 |
All grade AEs (%) | 74.1 | NR | 54.2 | 92.3 | 96.8 | 91.7 | 100 |
Grade 3–5 AEs (%) | 29.6 | 22.2 | 8.3 | 24.5 | 16.1 | 42.8 | 87.0 |