Pembralizumab |
|
|
|
|
|
|
|
KEYNOTE-012 [49] |
PD-1 |
1b |
Pembrolizumab |
Any |
39 with positive PD-L1 |
ORR (%): 22 (95% CI, 10-39; all PR) |
|
KEYNOTE-059 (cohort 1) [50] |
PD-1 |
2 |
Pembrolizumab |
≥ 3rd |
259 |
ORR (%): 11.6 (95% CI, 8.0–16.1; CR in 2.3) |
|
Median response duration (mo): 8.4 (1.6 +a to 17.3 +) |
|
OS (mo): 5.6; PFS (mo): 2.0 |
|
KEYNOTE-061 [51] |
PD-1 |
3 |
Pembrolizumab |
2nd |
592 (395 with CPS ≥ 1) |
OS (mo): 9.1 vs. 8.3 (HR, 0.82; 95% CI, 0.66-1.03) |
|
PaCIitaxel |
PFS (mo): 1.5 vs. 4.1 (HR, 1.27; 95% CI, 1.03-1.57) (both analyses in the subgroup of positive PD-L1) |
|
KEYNOTE-062 [52] |
PD-1 |
3 |
Pembrolizumab vs |
1st |
763 with CPS ≥ 1 (281 with CPS ≥ 10) |
OS (mo): 10.6 vs. 12.5 vs. 11.1 (CPS ≥ 1) |
|
Pembrolizumab + cisplatin + 5-FU or capecitabine |
OS (mo): 17.4 vs. 12.3 vs. 10.8 (CPS ≥ 10) |
|
PFS (mo): 2.0 vs. 6.9 vs. 6.4 (CPS ≥ 1) |
|
Placebo + cisplatin + 5-FU or capecitabine |
PFS (mo): 2.9 vs. 5.7 vs. 6.1 (CPS ≥ 10) |
Nivolumab (± ipilimumab) |
|
|
|
|
|
|
|
CheckMate-032 [53] |
PD-1 |
1/2 |
Nivolumab 3 mg/kg nivolumab 1 mg/kg + ipilimumab 3 mg/kg |
≥ 2nd |
160 |
ORR (%): 12 vs. 24 vs. 8 (independent of PD-L1 status) |
|
CTLA-4 |
|
Nivolumab 3 mg/kg+ipilimumab 1 mg/kg |
12-mo PFS rates (%): 8 vs. 17 vs. 10 |
|
12-mo OS rates (%): 39 vs. 35 vs. 24 |
|
ONO-4538-12, ATTRACTION-2 [46] |
PD-1 |
3 |
Nivolumab alone placebo |
≥ 3rd |
493 |
OS (mo): 5.26 vs. 4.14 (HR, 0.63; 95% CI, 0.51-0.78) |
|
12-mo OS rates (%): 26.2 vs. 10.9 |
|
ATTRACTION-4, part 1 [54] |
PD-1 |
2 |
Nivolumab + oxaliplatin+capecitabine |
1st |
40 |
ORR (%): 76.5 vs. 57.1 |
|
Nivdumab+oxaliplatin+S-1 |
PFS (mo): 10.6 vs. 9.7 |
|
ATTRACTION-4, part 2 |
PD-1 |
3 |
Nivolumab + oxaliplatin+S-1 or capecitabine Placebo + oxaliplatin+S-1 or capecitabine |
1st |
Approx. 650 |
Ongoing |
|
CheckMate-649 [55] |
PD-1 |
3 |
Nivolumab + ipilimumab |
1st |
870 |
Ongoing |
|
CTLA-4 |
Nivolumab + oxaliplatin + 5-FU or capecitabine Oxaliplatin + 5-FU or capecitabine |
Others |
|
|
|
|
|
|
|
JAVELIN Gastric 100 [58] |
PD-L1 |
3 |
Avelumab |
Maintenance after 1st-line |
499 |
Ongoing |
|
BSC after response or stability to oxaliplatinb + fluoropyrimidine |
|
JAVELIN Gastric 300 [57] |
PD-L1 |
3 |
Avelumab |
3rd |
371 |
OS (mo): 4.6 vs. 5.0 (HR, 1.1; 95% CI, 0.9-1.4) |
|
PaCIitaxel or irinotecan |
PFS (mo): 1.4 vs. 2.7 (HR, 1.73; 95% CI, 1.4-2.2) |
|
ORR (%): 2.2 vs. 4.3 |
|
NCT02340975 [59] |
PD-L1 |
1b/2 |
Durvalumab (anti-PD-L1) |
≥ 2nd |
94 (phase 2; as of Sep 13, 2017) |
Ongoing |
|
CTLA-4 |
Tremelimumab (anti-CTLA-4) |
|
Durvalumab+tremelimumab |
|
NCT01968109 [60] |
LAG-3 |
1/2a |
Relatlimab (anti-LAG3) vs. Relatlimab + nivolumab |
Last |
Advanced solid tumors |
Ongoing |
|
PD-1 |