Table 1 Clinical trials investigating the benefit of immune checkpoint inhibitors in MMR-D/MSI-H CRC patients

From: Immune checkpoint inhibitors for the treatment of MSI-H/MMR-D colorectal cancer and a perspective on resistance mechanisms

Study

Le et al.10

Overman et al.9

Overman et al.12

Design

Phase 2

Phase 2

Phase 2

Number of CRC patients enrolled in the study

A total of 41 patients with various cancer including 10 with metastatic MMR-D/MSI-H CRC

74 metastatic MMR-D/MSI-H CRC patients

119 metastatic MMR-D/MSI-H CRC patients

Agent

Pembrolizumab

Nivolumab

Nivolumab and ipilimumab

Dose

10 mg/kg every 2 weeks

3 mg/kg every 2 weeks

Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks ×4 followed by nivolumab 3 mg/kg every 2 weeks

ORR

40%

31%

55%

PFS

PFS rate at ~5 months (20 weeks) was 78%

PFS rate at 12 months was 50%

PFS rates at 9 months and 12 months were 76% and 71%, respectively

Common adverse effects

Fatigue (32%), rash (24%), diarrhoea (24%), pancreatitis (15%)

Fatigue (23%), diarrhoea (22%), pruritus (10%), rash (10%)

Diarrhoea (22%), fatigue (18%), pruritus (17%), rash (11%), hypothyroidism (14%)

Biomarkers investigated

CD8 and PD-L1 expressions were not predictors of outcome

BRAF, KRAS mutations, PD-L1 expression and Lynch syndrome were not predictors of response

BRAF, KRAS mutations, PD-L1 expression and Lynch syndrome were not a predictor of response

  1. CRC Colorectal cancer, MMR-D Mismatch repair deficiency, MSI-H Microsatellite instability high, ORR Overall response rate, PFS Progression-free survival, PD-L1 Programmed death-ligand 1
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