NSCLC | SCLC | ||||||
---|---|---|---|---|---|---|---|
Study | Design | ORR, PFS, and OS | TRAE | Study | Design | ORR, PFS, and OS | TRAE |
First-line | |||||||
NCT 00527735 [48] II R 1: 1: 1 N = 204 | 1. Placebo+Pacl+Carbo 2. Concurrent Ipi+Pacl+Carbo 3. Phased Ipi+Pacl+Carbo | irBORR, 18%, 21%, 32% mWHO-BORR, 14%, 21%, 32% Median irPFS, 4.6 m, 5.5 m, 5.7 m Median PFS, 4.2 m, 4.1 m, 5.1 m Median OS, 8.3 m, 9.7 m, 12.2 m | G3-4 6% 20% 15% | NCT 00527735 [49] II R 1: 1: 1 N = 130 | 1. Placebo+Pacl+Carbo 2. Concurrent Ipi+Pacl+Carbo 3. Phased Ipi+Pacl+Carbo | irBORR, 53%, 49%, 71% mWHO-BORR, 49%, 33%, 57% Median irPFS, 5.3 m, 5.7 m, 6.4 m Median PFS, 5.2 m, 3.9 m, 5.2 m Median OS, 9.9 m, 9.1 m,12.9 m | G3-4 9% 21% 17% |
NCT01285609 [50] III R 1: 1 N = 749 | 1. Phased Placebo+Pacl+Carbo 2. Phased Ipi+Pacl+Carbo | BORR, 47%, 44% Median PFS, 5.6 m, 5.6 m Median OS, 12.4 m, 13.4 m | G3-4 35% 51% | CA184-156 [51] III R 1, 1 N = 954 | 1. Phased Placebo+Etop+Plat 2. Phased Ipi+Etop+Plat | BORR, 62%, 62% Median PFS, 4.4 m, 4.6 m Median OS, 10.9 m, 11.0 m | G3-5 11% 22% |
IMpower131 [52] III R 1: 1 N = 578 | 1. Atezo+Nab-Pacl+Carbo 2. Nab-Pacl+Carbo | ORR, 49%, 41% Median PFS, 6.3 m, 5.6 m Median OS, 14.0 m, 13.9 m | G3-5 67% 58% | IMpower133 [53] III R 1: 1 N = 403 | 1. Atezo+Etop+Carbo 2. Placebo+Etop+Carbo | ORR, 60.2%, 64.4% Median PFS, 5.2 m, 4.3 m Median OS, 12.3 m, 10.3 m | G3-5 58.1% 57.6% |
IMpower132 [54] III R 1: 1 N = 403 | 1. Atezo+Pem+Plat 2. Placebo+Pem+Plat | ORR, 47%, 32% Median PFS, 7.6 m, 5.2 m Median OS,18.1 m, 13.6 m | G3-5 58.1% 57.6% | ||||
IMpower150 [55] III R 1: 1 N = 692 | 1. Atezo+Bev+Pacl+Carbo 2. Bev+Pacl+Carbo | ORR, 63.5%, 48% Median PFS, 8.3 m, 6.8 m Median OS,19.2 m, 14.7 m | G3-5 58.5% 50% | ||||
Second-line and beyond | |||||||
CheckMate 017 [56] Squamous III R 1: 1 N = 272 | 1. Nivo 2. Docetaxel | ORR, 20%, 9% Median PFS, 3.5 m, 2.8 m Median OS, 9.2 m, 6.0 m 1-year OS, 42%, 24% | G3-4 7% 55% | CheckMate 032 [57] I/II NR, N = 216 | 1. Nivo 3 mg/kg 2. Nivo 1 mg/kg + Ipi 3 mg/kg 3. Nivo 3 mg/kg + Ipi 1 mg/kg. | ORR, 10%, 23%, 19% Median PFS, 1.4 m, 2.6 m, 1.4 m Median OS, 4·4 m, 7.7 m, 6.0 m 1-year OS, 33%, 43%, 35% | G3-4 13% 30% 19% |
CheckMate 057 [58] Nonsquamous III R 1: 1 N = 582 | 1. Nivo 2. Docetaxel | ORR, 19%, 12% Median PFS,2.3 m, 4.2 m Median OS, 12.2 m, 9.4 m 1-year OS, 51%, 39% | G3-4 10% 54% | CheckMate 331 [59] III R 1: 1 N = 569 | 1. Nivo 2. Topotecan/Amrubicin | ORR, 13.7%, 16.5% Median PFS, 1.5 m, 3.8 m Median OS, 7.5 m, 8.4 m 1-year OS, 37%, 34% | G3-4 4.7% 74% |
KEYNOTE-010 [60] PD-L1 ≥ 1% II/III R 1: 1: 1 N = 1034 | 1. Pembro 2 mg/kg, 2. Pembro 10 mg/kg 3. Docetaxel 75 mg/m2 | ORR, 18%, 18%, 9% Median PFS, 3.9 m, 4.0 m, 4.0 m Median OS, 10·4 m, 12.7 m, 8.5 m 1-year OS, 43.2%, 52.3%, 34.6% | G3-5 13% 16% 35% | KEYNOTE-028 KEYNOTE-158 [61] Ib/II N = 83 | Pembro | ORR, 19.3% Median PFS, 2.0 m Median OS, 7.7 m 1-year OS, 20.7% | G3-5 8% |
POPLAR [62] II R 1: 1 N = 287 | 1. Atezo 2. Docetaxel | ORR, 15%, 15% Median PFS, 2.7 m, 3.0 m Median OS, 12.6 m, 9.7 m | G3-4 11% 39% | IFCT-1603 [63] II R 2: 1 N = 64 | 1. Atezo 2. Etop+Carbo/Topotecan | 6-week ORR, 2.3%, 10% Median PFS, 1.4 m, 4.3 m Median OS, 11.4 m, 9.4 m | G3-4 4.2% ~ 35% |
OAK [64] III R 1: 1 N = 850 | 1. Atezo 2. Docetaxel | ORR, 14%, 13% Median PFS, 2.8 m, 4.0 m Median OS, 13.8 m, 9.6 m | G3-4 15% 43% | ||||
Maintenance | |||||||
PACIFIC [65] III R 2: 1 N = 709 | 1. CRT+Durva 2. CRT+Placebo | Median PFS, 17.2 m, 5.6 m Median OS, NR, 28.7 m 1-year OS, 66.3%, 55.6% | G3-4 30.5% 26.1% | CheckMate 451 III R 1: 1: 1 N = 810 | 1. Nivo 2. Nivo+Ipi 3. Placebo | Maintenance nivo/nivo+ipi did not improve OS | NA |
NCT02359019 [66] II N = 45 | Pembro | Median PFS, 1.4 m Median OS, 9.6 m | ~ 15% |