Table 1. Most relevant studies with immune checkpoint inhibitors in the second-line setting of advanced colorectal cancer.
| Trial | Phase | Agent (Dosage) | N | Target population | ORR | PFS | OS | G3-4 TRAEs |
|---|---|---|---|---|---|---|---|---|
| Keynote-028 | Ib | Pembro (10 mg/kg/q2wk) | 23 | PD-L1+ mCRC | 1/23 | - | - | - |
| Keynote-028 | II | Pembro (10 mg/kg/q2wk) | 78 | MMRd cancers | CRC: 52% Non-CRC: 54% |
NR 2-y PFS: 53% |
NR 2-y OS: 64% |
|
| Keynote-164 | II | Pembro (200 mg/q3wk) | 124 | MSI-H/MMRd mCRC A: 1 prior line B: >2 prior lines |
A, B: 33% | A: 2.3 m B: 4.1 m |
A: 31.4 m B: NR |
A: 16% B: 13% |
| CheckMate-142 | II | Nivo (3 mg/kg/q2wk) | 74 | MSI-H/MMRd mCRC with 1 prior line | 31% | 1-y PFS: 50.4% | 1-y OS: 73.4% | - |
| CheckMate-142 | II | Nivo (3 mg/kg/q2wk) + Ipi (1 mg/kg/q4wk) × 4 cycles →Maintenance Nivo |
119 | MSI-H/MMRd mCRC with >1 prior lines | 55% | 1-y PFS: 71% | 1-y OS:85% | 32% |
| IMblaze 370 | III | Atezo (840 mg/q2wk) + Cobimetinib (60 mg/qd 1–21) versus atezo (1200 mg/q3wk) versus regorafenib (160 mg/qd 1-21) | 363 | MSS mCRC (95%) MSI-H mCRC (5%) |
- | - | 8.87 versus 7.10 vs 8.51 m | - |
Atezo: Atezolizumab, Ipi: Ipilimumab, mCRC: Metastatic colorectal cancer, MMRd: Mismatch-repair deficient, MSI-H: Microsatellite instability-high, MSS: Microsatellite stable, N: Number of patients, Nivo: Nivolumab, NR: Not reached, ORR: Objective response rate, OS: Overall survival, Pembro: Pembrolizumab, PFS: Progression-free survival, TRAEs: Treatment-related adverse events