Table 1.
KEYNOTE-177 | CheckMate 142 | KEYNOTE-164 | KEYNOTE-016 | |||||
---|---|---|---|---|---|---|---|---|
Treatment line | 1st | 1st | ≥ 2nd | ≥ 2nd | ≥ 2nd | ≥ 3rd | ≥ 3rd | |
Phase | III | II | II | II | II | II | ||
Number of patients | 153 | 154 | 45 | 74 | 119 | 63 | 61 | 10 |
Regimen | Pembro | Chemo | Nivo + Ipi* | Nivo | Nivo + Ipi** | Pembro | Pembro | Pembro |
ORR | 44% | 33% | 60% | 31% | 55% | 33% | 33% | 40% |
DCR | 65% | 75% | 84% | 69% | 80% | 57% | 51% | 90% |
mPFS (months) | 16.5 | 8.2 | NR | 14.3 | NR | 4.1 | 2.3 | NR |
12-month PFS rate | 55% | 37% | 77% | 50% | 71% | 41% | 78% (at 20 weeks) |
|
mOS (months) | - | - | NR | NR | NR | NR | 31.4 | NR |
12-month OS rate | - | - | 83% | 73% | 85% | 76% | 72% | - |
Abbreviations: dMMR, deficient mismatch repair; MSI-H, microsatellite instability-high; Pembro, pembrolizumab; Nivo, nivolumab; Ipi, ipilimumab; Chemo, chemotherapy; ORR, overall response rate; DCR, disease control rate; PFS, progression-free survival, OS, overall survival; NR, not reached.
* Nivo 3 mg/kg biweekly + Ipi 1 mg/kg every 6 weeks
** Nivo 3 mg/kg + Ipi 1 mg/kg every 3 weeks (four doses) followed by Nivo 3 mg/kg biweekly