Table 1 Comparison of two major phase III studies of dMMR/MSI-H mCRC immunotherapy
Pembrolizumab (KEYNOTE 177, First Line) | Nivolumab plus Ipilimumab (CheckMate 8HW, All Line)2 | Nivolumab (CheckMate 8HW, All Line) | ||
|---|---|---|---|---|
Efficacy | ||||
PFS | 54.1 (54.1 - NE)a | 16.5 (5.4–38.1)a | NR (53.8 - NE) | 39.3 (22.1 - NE) |
12 m PFS | 79% (72–84) | 55.3% (47.0–62.9) | 76% (71–80) | 63% (57–68) |
24 m PFS | 74% (67–80)a | 48.3% (39.9–56.2) | 71% (65–76) | 56% (49–61) |
36 m PFS | 69% (61–76)a | 42.3% (34.0–50.4) | 68% (62–73) | 51% (45–57) |
OS | - | NR (49.2 - NE) | - | - |
ORR | - | 45.1% (37.1–53.3) | 71% (65–76) | 58% (52–64) |
CR rate | - | 13.1% | 30% | 28% |
PD rate | - | 29.4% | 10% | 19% |
Special subgroup (HR)b | versus chemotherapy | versus chemotherapy | ||
Overall | HR: 0.21 (0.14–0.31)a | HR: 0.60 (0.45–0.80) | HR: 0.63 (0.49–0.82) | |
Wide type BRAF/RAS | - | HR: 0.44 (0.29–0.67) | HR: 0.64 (0.39–1.06) | |
KRAS / NRAS mutation | HR: 0.24 (0.09–0.63) | HR: 1.19 (0.68–2.07) | HR: 0.76 (0.44–1.31) | |
BRAF V600E | - | HR: 0.50 (0.31–0.80) | HR: 0.62 (0.39–0.97) | |
Liver metastases | HR: 0.11 (0.05–0.25) | - | HR: 0.68 (0.44 -1.03) | |
Lung metastases | - | - | - | |
Peritoneal metastases | HR: 0.19 (0.10–0.34) | - | HR: 0.55 (0.37–0.82) | |
Lynch syndrome | - | - | HR: 0.90 (0.47–1.72) | |